This protocol is for a feasibility study of a mindfulness-based stress reduction (MBSR) program adapted for pregnant women with psychosocial vulnerabilities. The rationale for the study is the need for a wider array of evidence-based options to address prenatal mental health care needs in pregnant women. MBSR is a promising mental health intervention but has not yet been adapted for pregnant women with the aim of addressing prenatal mental health. The purpose is thus to evaluate the feasibility, acceptability, and clinical outcomes of an adapted MBSR program, prenatal MBSR, compared to usual care to inform a randomized controlled trial.Pregnant women (n = 60) referred to an outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark, will be recruited for the study. The design is a single-center feasibility trial, with prenatal MBSR, as an add-on to usual care. The primary outcome is to assess the feasibility of a full-scale randomized controlled trial. The secondary feasibility outcome includes possible effects of the adapted MBSR program estimated by self-report questionnaires measuring stress, anxiety, depression, well-being, decentering, reflective functioning, mindfulness, and compassion. Participants will be randomized in a 1:1 ratio to prenatal MBSR or usual care.Good Start to Family Life study anchored at Copenhagen University Hospital, Amager and Hvidovre, Denmark. Teaching the skills of mindfulness meditation to a psychosocially vulnerable group of pregnant women could prove a viable and non-pharmacological approach to reduce stress, improve mental health, and provide support in the transition to parenthood. The outcomes of the feasibility study will inform the design of a fully powered randomized controlled trial.The study is part of the NCT04571190. Registered on September 30, 2020ClinicalTrials.gov, The online version contains supplementary material available at 10.1186/s40814-021-00860-w. Good Start to Family Life study, and the primary aim is to address the need of psychosocially vulnerable pregnant women and care providers. This in order to provide a wider array of evidence-based and non-pharmacological options to improve prenatal mental health. Mindfulness-based interventions are promising non-pharmacological interventions for mental disorders or symptoms, and performance has been found to be equivalent to evidence-based treatments, such as cognitive behavioral therapy and antidepressant medication for some disorders [This protocol is for a feasibility study of an adapted mindfulness-based stress reduction (MBSR) program for psychosocially vulnerable pregnant women referred to a hospital-based outpatient clinic specialized in antenatal care. Reasons for referral to the outpatient clinic are mental disorders, substance abuse, or other psychosocial vulnerabilities such as domestic violence or a history of sexual abuse. The protocol is part of the isorders , 2. Moreisorders . The adaEntering motherhood is one of the most intensive transitional stages in life that require adaptations on many levels , and thiMindfulness can be conceptualized as an attentional skill , and theMore studies have addressed mental health in pregnancy using mindfulness-based interventions, e.g., MBSR; mindfulness-based cognitive therapy (MBCT); or mindfulness-based yoga. Systematic reviews and meta-analyses point towards a trend in favor of mindfulness-based interventions but state that shortcomings in study designs limit the conclusions. The majority of studies are pilot and feasibility trials that are not adequately powered to demonstrate the effectiveness , 18, 19.The primary aim of the study is to determine the feasibility and acceptability of the prenatal MBSR program delivered to psychosocially vulnerable pregnant women in a hospital-based setting. The objectives are to examine the following: (1) acceptance of trial participation; (2) acceptance of allocated interventions; (3) risk of bias: loss to follow-up in the study arms, acceptance and compliance with the intervention, i.e., attending ≥ 5 sessions; and (4) the extent of missing data leading to missing outcomes. The secondary aim is to explore the potential efficacy of the prenatal MBSR program on self-reported measures of stress, well-being, anxiety, depression, reflective functioning, mindfulness, and self-compassion. The outcomes of the feasibility study will inform the design of a fully powered RCT.The protocol is for a randomized, single-center feasibility trial comparing the prenatal MBSR program as an add-on to usual care with usual care alone. Participants will be randomized in a 1:1 ratio to an intervention or waitlist control group. A completed SPIRIT checklist is available in The study will be carried out at an outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark. The outpatient clinic is specialized in providing interdisciplinary antenatal care for psychosocially vulnerable pregnant women. In Denmark, there is free and equal access to most healthcare services including hospitals, general practitioners, and practicing specialists. The International Classification of Diseases, Tenth Revision (ICD-10) is used for the classification of diseases. The Copenhagen University Hospital, Amager and Hvidovre, is located in the greater Copenhagen area and is the country’s largest birthplace with 7000 annual births. Every year, about 800 pregnant women are referred to the outpatient clinic by their general practitioner with the first consultation being around 18 weeks’ gestation. Reasons for referral are past or present mental disorders, substance abuse, or other psychosocial vulnerabilities such as domestic violence or a history of sexual abuse. About 66% of all referrals are substantiated by a psychiatric diagnosis.Pregnant women referred to the outpatient clinic are recruited at their first or second consultation with a midwife. The first consultation is on average approximately 18 weeks’ gestation and the second approximately 24 weeks’ gestation. In order to determine eligibility, the midwife will use the information from the patient record regarding reasons for a referral to the outpatient clinic. The information includes past or present psychiatric diagnoses, and past or present substance abuse. The information is registered in an Excel sheet along with name and contact information and passed on to the responsible researcher. The midwife will provide verbal information about the study and email written information to eligible women, who express an interest in participating in the study. An online zoom interview is then scheduled with the responsible researcher. The women will be encouraged to find a time and a place where the interview can take place undisturbed, and information is provided about the possibility of having a partner or other person present. The online format provides the women with an opportunity to participate in the interview in their own homes as they may feel particularly vulnerable during the corona pandemic. The corona pandemic, coupled with our experience working with this population, led to offering this option. If an online interview is not possible, the interview will be conducted at the outpatient clinic. The interview will contain information about the study such as study criteria, procedures, randomization, intervention, and motivation for study participation. Women who consent to study participation will be asked to sign the consent form within 1 week from the interview. The women can choose to either return a signed consent form by email or sign the consent form at the outpatient clinic, who will then return it to the responsible researcher.The aim of the study is to address prenatal mental care in psychosocially vulnerable women with no particular attention to any specific psychiatric diagnosis or other psychosocial vulnerability. However, there are some cases where MBSR is not suited, which is specified in the exclusion criteria.Estimated due date no sooner than 3 months from the start of the intervention. The adapted MBSR program includes nine weekly sessions, and these criteria were included in order for the women to be able to complete the intervention.Eighteen + years of age.Speak and write Danish.Available for group intervention scheduled sessions. Being unavailable for two or more sessions is a reason for exclusion from study participation.Written informed consent to study criteria.The following are the inclusion criteria:Concurrent substance abusePsychotic disorders and post-traumatic stress disorderSuicidalityThe following are the exclusion criteria:The criteria for discontinuation of study participation are (1) if requested by the participant, and (2) if the participant is absent from the prenatal MBSR class for two consecutive sessions and does not respond to email or phone calls.When adapting MBSR to high-risk pregnancies, the essential program elements characterizing MBSR were maintained  and inteThe adaptations draw upon both empirical data as well as existing research and theory. The process of adapting the MBSR program was led by a psychiatrist, with extensive clinical and MBSR teaching experience, in collaboration with psychologists and researchers with relevant clinical and/or MBSR teaching experience.In terms of empirical data, all staff at the outpatient clinic initially participated in a standard MBSR program. The purpose was for the staff to get a sense of what mindfulness training involves, by experiencing it for themselves, and, further, to generate knowledge that could inform the organization of an MBSR course for psychosocially vulnerable pregnant women. Thus, two focus group interviews with the staff were conducted after finalizing the 8-week MBSR course. The interview questions assessed the potential barriers for program attendance, the structure of the program, how to provide the best support to ensure attendance, and criteria for success.The prenatal MBSR program has been pretested in five groups of pregnant women referred to the outpatient clinic. There was a maximum of 15 participants in each group. A psychiatrist and a psychologist with extensive clinical experience and MBSR teaching experience taught the groups. A midwife or a psychologist, from the outpatient clinic, participated in each of the groups. Pre- and post-self-report measures were collected. Attendance and dropout rates were systematically registered. Subsequent individual interviews with the participants and participating staff resulted in some adjustments to the program. In sum, the developmental process resulted in the following adaptations to the standard MBSR program: The first adaptation is that the prenatal MBSR program consists of nine 2-h sessions and no full-day  session. The rationale for including shorter sessions and no full-day sessions is to make the program more adaptable for the clinical context that it is intended for. The second adaption relates to the fact that transition to motherhood is often presented as an exciting and joyful time with naturally developing emotional growth by modern society and the media . The ideThe prenatal MBSR program will be delivered by two highly trained MBSR teachers from the Danish Center for Mindfulness, Aarhus University. Both have been involved in the process of adapting the MBSR program to the present context and have extensive clinical psychiatric experience.Standard clinical practice, usual care (TAU), consists of routine pregnancy visits to the outpatient antenatal clinic at Copenhagen University Hospital, Amager and Hvidovre, and to a general practitioner. A multidisciplinary approach involves primarily preventive counseling by midwives and, in some cases, consultations with a physician or social worker throughout the pregnancy and follow-up until the early post-partum period. In some cases, usual care may include consultations with a psychologist, although usually limited to a few sessions, and in more severe cases, referral to psychiatric treatment. All consultations are individual, and the first session is planned in gestational week 18, with an average of six following consultations. Additional consultations are planned if deemed necessary.The primary outcome of the study is to access the feasibility of a full-scale RCT, including accessing acceptance of trial participation among psychosocially vulnerable pregnant women. Acceptance of trial participation includes recruitment rate, acceptance of allocated interventions, compliance , non-completion, and adverse events.The recruitment process will be systematically registered in close collaboration between the Danish Center for Mindfulness, Aarhus University, and the outpatient clinic at Copenhagen University Hospital. Project meetings, every other week, will provide an opportunity for continuous evaluation of the recruitment process.Prenatal MBSR class attendance will be registered at each session, and participants will be asked to notify the teacher in case of non-participation. Participants canceling two consecutive sessions will be contacted by phone, and the responsible midwife will be informed in order to provide support and prevent dropout. Adherence and acceptability of the prenatal MBSR program will be evaluated after the trial is finalized by examining attendance, time spent on home practice, and overall satisfaction with the program. On a daily basis, participants will be asked to register time spent on home practice. Satisfaction with the program will be evaluated at the last session. The prenatal MBSR teacher will register any adverse event ascribed to the prenatal MBSR program and notify the responsible researcher.The secondary feasibility outcome includes the possible effects of the prenatal MBSR program as estimated by self-report measures assessing stress, anxiety, depression, well-being, decentering, reflective functioning, mindfulness, and compassion. The questionnaire packet is built and managed via REDCap (Research Electronic Data Capture) hosted by Aarhus University. Reminders will be emailed after 1 week in case of non-response.The Perceived Stress Scale 10-item version (PSS-10) is a global measure of stress . The queThe Edinburgh Depression Scale (EDS) is a widely used screening questionnaire containing questions on how the respondent has felt in the past 7 days . The queThe Depression Anxiety Stress Scales (DASS-21)  has threThe WHO-5 is a short and generic global rating scale measuring subjective well-being . It consParental reflective functioning refers to the caregiver’s capacity to reflect upon his/her own internal mental experiences as well as those of the child . The PreDecentering reflects the capacity to take a non-judgmental and accepting stance regarding one’s thoughts and emotions as opposed to identifying with them . The decThe Five Facet Mindfulness Questionnaire (FFMQ) assesses five general facets of being mindful in daily life: observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience. Items are rated on a 5-point Likert scale ranging from 1 “never or very rarely true” to 5 “very often or always true.” Higher scores suggest higher levels of mindfulness. Previous studies have provided good support for the construct validity of the FFMQ; furthermore, four of the five facets (except for “acting with awareness”) have been found to be significantly correlated with meditation experience .The Self-Compassion Scale measures the ability to have a healthy stand towards oneself that does not involve evaluations of self-worth . The scaBaseline data on age, marital status, number of children, social support, working status, education, obstetric complications , current use of psychotropic medication, and prior and current history of a mental disorder or drug abuse will be collected. Assessment of health practices will include self-reports of level and type of habitual exercise, smoking, and alcohol. Information on time of birth (weeks) and birth weight will be collected postnatally.The study will include a total of 60 participants. This sample size is justified based on the design and objectives of the study .Eligible participants will be randomized in a 1:1 ratio to either prenatal MBSR + usual care or usual care alone using the REDCap randomization module hosted by Aarhus University. REDCap is a secure, web-based application designed to support data capture for research studies . A data Statistical analyses will be performed using SPSS for Windows . Skewness, kurtosis, and visual inspection of normal Q-Q plots will be used to inspect normality. Descriptive statistics will be presented as mean and SDs or median and interquartile range (IQR) depending on the distribution of the continuous variables or as frequencies for categorical variables.Recruitment, participation, and retention rates will be reported and presented in a CONSORT flow diagram . Data co2). A loss to intervention analysis will be conducted for participants attending < 5 sessions of the intervention applying a similar approach.Acceptability of the intervention will be assessed by dropout rates, by computing the mean number of completed sessions, and time spent on at-home practices in the prenatal MBSR group. Participation in ≥ 5 sessions will be considered compliant with the program. A loss to 12-week follow-up analysis will be conducted for age, education, employment, history of a mental disorder, participation in < 5 sessions of the intervention, and pre-scores on the PSS-10 by means of t-test and chi-squared test  will be conducted to compare the pre- and post-questionnaire scores of the intervention and control groups. In case of skewed distributions in baseline variables, e.g., age and history of mental disorders, logistic regression analyses will be performed.Group affiliation will be concealed for the researcher performing the statistical analyses.Participants will not be blinded. Keeping participants blind to this type of intervention would not be possible. Part of the study is to understand if this introduces any difficulties  into the study that would need to be addressed before a larger trial.Participation in a mindfulness-based program has not been associated with major side effects when the program is delivered by a certified teacher. The Danish Center for Mindfulness, Aarhus University, is affiliated with the Center for Mindfulness at Brown University and collaborates on setting international standards for education and teacher training. In the present study, a psychiatrist and a psychologist will be teaching the prenatal MBSR program. Both have extensive clinical experience and are certified mindfulness teachers. Some side effects have been reported in connection with mindfulness training, such as aggravation of symptoms that could be due to the increased focus on internal states and feelings of losing oneself. If any adverse events should occur, the teachers have the relevant expertise to ensure participant safety or referral to relevant treatment elsewhere. Both teachers are available for individual sessions between the program sessions. Any side effects related to the intervention will be systematically registered by the responsible researcher and published with the results of the study. The possible benefits of mindfulness training in pregnancy as described in earlier sections thus outweighs the potential side effects of the intervention. Moreover, there is a need for more evidence-based, non-pharmacological options for addressing prenatal mental healthcare needs in vulnerable groups for the benefit of both mother and fetus. The adaptations made to the original MBSR program require more research in order to establish an evidence base for the prenatal MBSR program, which is initiated with this feasibility study.The evidence to date suggest that MBSR and mindfulness-based interventions have great potential in improving mental health in both clinical and non-clinical populations. There is a need for evidence-based and non-pharmacological options addressing mental health during pregnancy. Teaching the skills of mindfulness meditation to a vulnerable group of pregnant women could prove as a viable and non-pharmacological approach, to improve mental health. Moreover, it may provide support in the transition to parenthood. It is anticipated that the findings from the study will access and determine the acceptability and feasibility of the prenatal MBSR program and inform the design of a fully powered randomized controlled trial. The results could also be relevant for other hospitals or healthcare settings working with pregnancy both in and outside of Denmark.The study was initiated in mid-January 2021.Good Start to Family Life Project including the management at the outpatient clinic, Oestifterne, and the Danish Center for Mindfulness. The involvement of the staff during the development of the prenatal MBSR program is described in the “The Danish Center for Mindfulness, Aarhus University, is responsible for the development and evaluation of the prenatal MBSR program. The developmental and evaluation process is carried out in close collaboration with the outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre. The collaboration includes project meetings every other week and regular meetings with staff at the clinic. Project meetings are held with the responsible parties involved in the Additional file 1. SPIRIT Checklist.


Approximately 20% of patients experience chronic pain after total knee arthroplasty (TKA). Due to the growing number of TKA procedures, this will affect an increasing number of people worldwide. Catastrophic thinking, dysfunctional illness perception, poor mental health, anxiety and depression characterize these non-improvers, and indicate that these patients may need individualized treatment using a treatment approach based on the bio-psycho-social health model. The present study developed an internet-delivered cognitive behavioral therapy (iCBT) program to be combined with exercise therapy and education for patients with knee osteoarthritis (OA) at increased risk of chronic pain after TKA.The development process followed the first two phases of the UK Medical Research Council framework for complex interventions. In the development phase, the first prototype of the iCBT program was developed based on literature review, established iCBT programs and multidisciplinary workshops. The feasibility phase consisted of testing the program, interviewing users, condensing the program, and tailoring it to the patient group. A physiotherapist manual was developed and adapted to physiotherapists who will serve as mentors.The development process resulted in an iCBT program consisting of 10 modules with educational texts, videos and exercises related to relevant topics such as goalsetting, stress and pain, lifestyle, automatic thoughts, mindfulness, selective attention, worry and rumination. A physiotherapist manual was developed to guide the physiotherapists in supporting the patients through the program and to optimize adherence to the program.The iCBT program is tailored to patients at risk of chronic pain following TKA, and may be useful as a supplement to surgery and/or exercise therapy. A multicentre RCT will evaluate the iCBT program in combination with an exercise therapy and education program. This novel intervention may be a valuable contribution to the treatment of OA patients at risk of chronic pain after TKA.NCT03771430 11/12/2018. The RCT is pre-registered at ClinicalTrials.gov:  Total knee arthroplasty (TKA) for osteoarthritis (OA) is quite a successful procedure, with improvements in pain, function and quality of life , 2. HoweHowever, the OARSI-based treatment modalities alone may not be sufficient for all patients. A growing literature suggests that non-improvers following TKA have a distinct preoperative psychological profile characterized by catastrophic thinking , dysfuncIn cognitive behavioral therapy (CBT), pain is recognized as a complex, subjective phenomenon, and the use of CBT in the management of chronic pain thus fits well with the bio-psycho-social health model , 25. ResOur research team aimed to take these results one step further and develop an evidence-based and internet-delivered CBT (iCBT) program for all OA patients who are candidates for TKA, but specifically targeted for patients less likely to benefit from standard TKA treatment. The program was designed to be combined with an exercise therapy and education program based on AktivA , consistDevelop an iCBT program to be combined with an exercise therapy and education program for patients with knee OA at increased risk of chronic pain after TKA (Phase 1)Thoroughly test and customize the program (Phase 2)The aims of the present research were to:This paper originates from the MultiKnee multi-center randomized controlled trial , investigating the effectiveness of an exercise therapy and education program combined with iCBT on pain and functional outcomes in patients with higher risk of chronic pain following TKA. The development process is presented according to guidance for reporting intervention development (GUIDED) .The UK Medical Research Council (MRC) framework for complex interventions  served an = 3), physiotherapists (n = 3), orthopedic surgeons (n = 4), psychologists (n = 2), a pain specialist and a health economist, all with long-term experience in clinical practice and research. The group met regularly to identify and define the topic and discuss theoretical and practical questions. Furthermore, a core group consisting of a physiotherapist, a nurse and an orthopedic surgeon with long-term experience from the TKA field, in addition to two psychologists with extensive experience in CBT and internet-based therapy, were responsible for designing the iCBT program.A multidisciplinary intervention development advisory group was established. The group was broadly composed of national and international representatives consisting of nurses :Discussions in the advisory group and results from the literature review formed the rationale, theory and goal for the intervention and the selection of included elements.The core treatment for knee OA is exercise therapy combined with education and weight reduction if needed . OA patiHence, the goal of the intervention is to increase patients’ awareness of their own thoughts and behavior, and to learn and practice new ones so they can initiate, maintain or resume their normal physical and social activities. Further learning goals are to increase patients’ confidence in making their own assessments and to learn techniques for dealing with pain in an appropriate way.The first draft of the iCBT program was designed from relevant elements of the commercially-available Braive program , which iSince the iCBT program elements from Braive were not specifically designed for OA patients, it was necessary to tailor and adjust the content by emphasizing OA pain and cognitions associated with OA pain. Two versions of the iCBT program were developed, one non-surgical version for OA patients, and one version for patients undergoing TKA surgery. A persona, an animated figure based on a typical OA or TKA patient, was created for each version of the program. The personas represent a figure that OA or TKA patients can identify with, and appear in all modules throughout the programs. To help patients see the relevance of the iCBT exercises in each module and how to implement them into their exercise therapy program, the iCBT exercises in both versions included lists of relevant examples for OA and TKA patients. Both versions were identical in content except for minor differences in the examples and personas. The interventional development advisory group, users and physiotherapists were consulted and contributed their input throughout development of the program. This phase yielded a prototype of an iCBT program with 12 modules and a manual for physiotherapists serving as patient mentors.In this stage, we evaluated whether the program was relevant, manageable and understandable for the patients and whether the program and the clinician manual were relevant for the physiotherapists. This process was characterized by feedback-loops where users and researchers were challenged to give input to refine the program.To evaluate the program’s relevance for OA patients, and its feasibility and acceptability, we conducted interviews with users in two rounds. For planning and conducting the interviews, Norman and Skinner’s eHealth literacy model  was emplThe first draft of the program was distributed to three users, two men and one woman, who had undergone TKA surgery, followed by individual interviews conducted by a physiotherapist. The interview guide and results from the first round of interviews are described in Table To discuss further condensation of the content, the professionals in the research group arranged a workshop. The aim was to tailor the program to the patient group and condense it to the most essential CBT elements. Priorities were made based on the literature , feedbacA physiotherapist manual was developed in order to ensure treatment fidelity. Four physiotherapists experienced in treating patients undergoing TKA surgery were introduced to the iCBT program and the physiotherapist manual to optimize their relevance and usefulness. A workshop was arranged where the physiotherapists discussed the relevance and feasibility of all elements of the manual. Revisions were made accordingly, such as clarification of the physiotherapist’s role and customization of the information sheet.Phase 2 resulted in a final version of the iCBT program consisting of ten modules Table , accompaThe iCBT program is presented according to the template for intervention description and replication (TIDieR) checklist and guide . To use The iCBT program consists of ten modules. Participants are encouraged to complete one module before moving on to the next. Each module follows a similar structure, consisting of psychoeducational texts and videos that present relevant topics for the module. Most of the modules include a video where the patients can follow the “persona” – the fictional character with OA or TKA, who undergoes either non-surgical treatment (version A) or TKA surgery (version B). Each module includes tasks related to the topics covered. Some tasks can be performed immediately ; others are expected to be done as behavioral experiments between the modules.The purpose of the first two modules is to help patients change their habits and lifestyles, and set new goals in areas that are important for pain management. Based on various psychoeducational texts and videos, patients are challenged to identify areas in which they want to change, and to set step-by-step goals for how the goals can be reached. Throughout the program, patients are challenged to continue to revise their goals in the subsequent sessions by describing the strategies they chose to apply and the progress they have made, and by setting additional goals for their rehabilitation.To optimize adherence to the program, physiotherapists will support the patients through telephone contact every second week. Using physiotherapists as mentors is intended to facilitate integration of the iCBT and exercise therapy, and increase the likelihood of generalization to daily life. The physiotherapists will participate in a one-day course, led by an experienced psychologist, to be able to support the patients throughout the program. The course includes an introduction to the iCBT program and the physiotherapist manual, in addition to education about CBT principles. The physiotherapist manual will support the physiotherapists and increase the consistency of mentoring the patients. The physiotherapist manual contains the same ten modules from the iCBT program, specific learning objectives for each module, and a list of themes the physiotherapist should consider discussing with the patients, including recommendations as to how each theme might be addressed. In addition, two extra learning modules are available for the physiotherapists. The first module contains an introduction to basic CBT and MI principles. The second module provides guidance on how to handle patients’ resistance and address challenges Table . FurtherThe cognitive-behavioral model focusing on the “cognitive diamond”, which illustrates the link between thoughts, emotions, bodily reactions and behavior , is the Some iCBT exercises are carried out throughout the program. A diary writing exercise is introduced at the beginning of the program, and patients are asked to write on different topics in the coming sessions. They are also introduced to a relaxation technique (progressive muscle relaxation) and are encouraged to practice it regularly. In a later module, they learn about mindfulness, including selective attention and conscious refocusing, and undergo an exercise in mindfulness that they are encouraged to use repeatedly .In the present paper, we have described the development process of an iCBT program for knee OA and TKA patients at increased risk of chronic pain after TKA surgery, to provide clinicians and researchers with enough details to replicate the program. The developmental process following the MRC framework resulted in an iCBT program consisting of ten modules and a manual to guide the physiotherapists mentoring the patients.One in five patients undergoing TKA have limited or no effect of the surgery when it comes to pain and function . They arWe base our study on current evidence suggesting that several of the risk factors for a suboptimal TKA outcome are modifiable . Because these psychological factors, combined with pain, may constitute significant barriers to participation in exercise therapy , we expeCBT-based treatment for persons at risk of poor outcome following TKA has been evaluated in several recent studies, which concluded that CBT alone is likely insufficient to improve TKA outcomes –70. WhilBecause the program is intended to be combined with an exercise therapy and education program, physiotherapists will mentor the patients through the program. Thus, the physiotherapists’ manual was designed to clarify and support the role of the physiotherapists. Using physiotherapists as mentors is in line with findings from a recent study , which dThis study is the first to create an iCBT program for patients with knee OA and patients undergoing TKA, to be combined with exercise therapy and education. In a recent systematic review, Calbring et al. demonstrated that iCBT targeting psychiatric and somatic conditions is as effective as face-to-face treatment for all conditions studied . For ourInternet-based CBT programs have been evaluated in other populations with chronic pain , 72 and Schuster et al.  listed sHowever, using online treatment programs may be challenging for patients without internet access or for those who are unfamiliar with using a computer or smartphone. It is therefore likely that the program is more applicable to younger patients who are familiar with using tablets, smartphones or computers. However, the user interface of our program is designed to be as simple and intuitive to use as possible and the program is supported by mentor physiotherapists, which may limit potential barriers to using such a program.It is estimated that 85% of research activity is wasted . The strWe have developed an iCBT intervention tailored to patients at risk of chronic pain following TKA. The development process followed the first two phases of the MRC framework for complex interventions. The iCBT program consists of 10 modules with educational texts, videos and exercises related to relevant topics. A physiotherapist manual guides physiotherapists in mentoring patients through the program. A planned multi-centre three-armed RCT will test the effectiveness of iCBT combined with an exercise therapy and education program.The iCBT intervention developed in this study may be a valuable contribution to the treatment of knee OA. It is easy to use and less time-consuming for patients and therapists than face-to-face programs. The result of the RCT may contribute to the general knowledge of how to treat patients at risk of an unfavorable TKA outcome. The intervention may benefit a substantial number of patients every year, as well as society by reducing costs associated with chronic pain.


Although cancer is the leading cause of death among Mexican-Americans, few community-based programs target obesity reduction as a way to reduce the prevalence of obesity-related cancer in underserved populations. Evidence suggests that obesity correlates with 13 types of cancer. The objective is to provide an overview of evaluation and selection of evidence-based content; details of the implementation process; modifications needed to tailor education programs to specific needs of different target audiences; and demonstrate challenges of implementing a community-based prevention program intended to reduce cancer incidence and mortality in Mexican-Americans. We used the Social Cognitive Theory (SCT) to develop a 10-topic menu of educational classes using elements of multiple evidence-based curricula. Outcome measures for physical activity and nutrition were determined using the International Physical Activity Questionnaire (IPAQ) and the Dietary Screener Questionnaire (DSQ). Weight status was determined using weight, body fat, and body mass index (BMI). To date, 2845 adults received wellness education from our program. Multiple delivery models were used to reach a larger audience; they included a 4-week model, 5-week model, employer model, low-income housing, 1- and 2-h sessions, and clinic encounters. Individuals were given education at multiple community locations including senior centers (14%), churches (0.6%), employers (17.6%), low-income housing (8.2%), community centers (16.6%), clinics (11.5%), and schools (32.5%). Our study indicates that our delivery model is feasible and can disseminate evidence-based obesity education. Further investigation is necessary to assess long-term behavioral change and to assess the most effective model for delivery. Cancer is the leading cause of death among Mexican-Americans and larger Latinx communities , 2. ReduThere has been a concerted effort to reverse current trends in obesity in Mexican-Americans through prevention and intervention programs primarily to prevent cardiovascular and metabolic diseases –7. Most Programs specific to Latinx populations primarily target children and their families , 16 withImplementing programs with populations and in environments not available during validation testing is a significant challenge. Most programs utilized Non-Latinx, urban Latinx, or non-Mexican–American Latinx populations , 9, 18. Pasos Para Prevenir Cancer is a community-based primary prevention program intended to reduce cancer incidence and mortality in Mexican-Americans living in El Paso, TX. The program utilizes curricula from evidence-based programs. This paper provides an overview of the evaluation and selection of evidence-based content, details of the implementation process, modifications needed to tailor to specific needs of different target audiences, and challenges to implementation. We will also provide lessons learned and next steps in widespread uptake of the Pasos Para Prevenir Cancer program.Pasos Para Prevenir Cancer is a primary prevention program funded by the Cancer Prevention and Research Institute of Texas (CPRIT) (PP180026). The program’s purpose is to provide obesity-related cancer prevention education to adults aged 18 years and older. We conducted a comprehensive review of existing programs and used elements from multiple evidence-based curricula to create a ten topic menu of courses. The menu allowed us to select educational material that met the needs of a socioeconomically diverse Mexican–American population living in El Paso, TX.We used the Social Cognitive Theory (SCT) as the underpinning of our curriculum design. Albert Bandura developed the SCT as a framework for understanding human behaviors . The corThe implementation process consisted of multiple steps using multiple strategies to maximize uptake and maintain fidelity to the evidence-based programming as much as possible . A timelPasos Para Prevenir Cancer. Criteria set for programs included consideration made on El Paso residents’ socioeconomic, cultural, and health literacy needs. In El Paso, bilingual programs are essential to maximizing English-dominant Mexican-Americans’ and younger U.S.-born participants’ reach. However, many previous programs targeted only monolingual Spanish participants  2 × 703 [Anthropometric measures ) helped determine participants’ weight status. We used a non-rigid measuring tape to measure waist circumference. Proper waist circumference measurement places the tape right above the participant’s hipbones and snugly and horizontally placed around the waist. The participant exhaled before the recording of final measurements . Height  2 × 703 .To date, the evaluation study consists of 272 participants. Table Pasos Para Prevenir Cancer is a program developed to deliver evidence-based obesity education tailored to the diverse Mexican–American population living in El Paso, TX. Considerations for implementation included accessing bilingual programming, tailored to the different levels of health literacy and interests, and varying delivery duration. Using this tailored approach, we were able to educate more than 4000 El Pasoans over 2 years.Cancer is the leading cause of death among Mexican-Americans , 2 and oPasos Para Prevenir Cancer are needed and have the potential of curbing cancer risk by educating Latinx populations at a large scale through a tailored approach.Most of the programs we evaluated targeted obesity prevention or reduction to help prevent heart disease or diabetes. No program focused on obesity-related cancer prevention despite growing incidence and mortality . ChallenTailoring evidence-based programming was required to reach large numbers of participants. In El Paso, most residents are Mexican–American; however, they vary in socioeconomic status, language preferences, and health literacy. Many programs focusing on Mexican-Americans or other minority groups targeted low-income children or older adults , 16, 30.While we were able to educate in-person or online 2845 participants in our education program, more evaluation is needed to determine which aspects of the program are most effective at inciting behavioral change. Additionally, the key to implementing tailored programs is assuring that participants receive in some way all aspects of the evidence-based information. Further investigation is needed to determine the most effective form of content delivery  in El Paso or similar settings. An additional limitation is that we do not have long-term data on the program’s effectiveness in creating meaningful behavioral change. Therefore, the next step to our implementation is to evaluate behavioral change and assess which program components were associated with change.Pasos Para Prevenir Cancer demonstrates the feasibility and a potential model for disseminating evidence-based obesity education. The next steps for Pasos Para Prevenir Cancer include assessing long-term behavioral change 6 and 12 months after participating in the program. Additionally, assessing different aspects of evidence-based education approaches will help determine which aspects have the best results.Despite limitations,


Central Italy suffered from the earthquake of 2016 resulting in great damage to the community. The purpose of the present study was to determine the long-term traumatic outcomes among the population. A preliminary study aimed at obtaining the Italian translation of the first 16 item of HTQ IV part [p < .05) and SQD-D subscales . ROC analysis suggested an area of .951 (95% CI = .917–.985) for the PTSD prediction. Basing on sensibility (.963) and specificity (.189), the best cut-off of 2.0 allowed discriminating for PTSD positive cases. After 20 months of the earthquake, the estimate prevalence of PTSD among the survivors is of 21.71% with a consistent and graded association between exposure variables and vulnerability factors  and PTSD symptoms.A Confirmatory Factor Analysis (CFA) revealed a HTQ five-factors solution as best model, with satisfactory indexes of fit. HTQ held a positive correlation with both the SQD-P (r = .65,  Earthquakes are unpredictable, uncontrolled disasters that cause widespread devastation threatening physical and psychological integrity of affected populations. Italy is one of the most seismically active countries in Europe. These disasters are associated with severe psychiatric disorders among survivors such as Major Depressive Episode (MDE), Generalized Anxiety Disorder (GAD), Panic Disorder, Obsessive-Compulsive Disorder (OCD), Post-Traumatic Stress Disorder (PTSD), specific phobias for loud sounds (thunders or thunderstorms), “quick trigger” suicidal episodes, substance abuse, and impaired quality of life –4. The mOn August 24, 2016, a Mw 6.0 earthquake hit Central Italy, overwhelming Amatrice and several minor towns and rural communities, with almost 300 deaths and leaving 30.000 people homeless. Reconstruction of the destroyed facilities was still lacking years after the earthquake. This situation hampered the recovery process even further and may having had further negative consequences on the population. The long-term psychological outcomes in the Center Italy population, however, are not yet known.Prevalence rates of PTSD subsequent an earthquake are extremely heterogeneous across research and range from 4% to 67%; causes for this variability include the population considered, the age groups considered, the time elapsed since the event, the sample size, and the study design. It is worth observing here, that together with PTSD, depression is one of the most typical psychiatric disorders appearing in earthquake survivors several weeks or months after traumatic events. Moreover, both disorders tend to endure over time. In addition to the considerable mental health burden, research studies also indicate that PTSD and depression are related with improved risk of cardiovascular diseases, diabetes, functional impairment, lower quality of life, and mortality . ClarifyThe influence of natural disasters on mental health varies for several pre-, peri- and post-disaster factors . Risk anThe main purpose of the current study was to estimate the long-term PTSD’s occurrence in a convenience sample from the Center Italy population. With this aim, we firstly obtained the Italian version of the first 16 items of part IV from the Harvard Trauma Questionnaire (HTQ) on non-exposed individuals exploring its psychometric properties . The HTQThe preliminary study consisted of translation to the Italian language and validation of the first 16 items of the HTQ IV part  investigN = 254 in total) filled in the complete questionnaire without missing data. After six months (October/November 2017), they were invited to participate in the test-retest.While a priori sample size determinations for AUC are highly susceptible to assumptions about the performance of the test, it was suggested that a sample size of 100 is generally sufficient to make a qualitative assessment of the utility of a test to run the factorial analysis , 32. GivThe Harvard Trauma Questionnaire (HTQ) was created , 21 beca-Administered PTSD Scale for DSM-IV  was utilized . This isV  was of V  was appV . Following the recruitment, a research assistant explained to the participants both the research aims and procedures asking their collaboration and signature of the informed consent. Participants filled the informed consent, the HTQ, the Screening Questionnaire for Disaster Mental Health (SQD) and the Binge Eating Scale (BES) completing all tests together with a questionnaire about socio-demographic data in a self-report mode. The criteria for exclusion from the study were: (1) history of severe brain injury; (2) diagnoses of intellectual disability or neurological damage; and (3) diagnoses of psychiatric disorders or being to drug intervention. Evaluations were administered during two periods .All analyses were carried out using the statistical program R version 4.0.1; lavaan  and sem The internal consistency, which refers to the scale reliability or the degree of consistency among the scores on items of an instrument concerning a particular sample or subsample of a population  was deteP ≥ 6 score, thus resulting above the cut-off for a diagnosis of probable PTSD and were therefore excluded from the following analyses. The remaining 232 participants  were mainly resident in the province of Parma . One hundred fifty of them  agreed to be called back for the re-test. Each subject provided consent, and potential participants were excluded if they were unable to provide written informed consent.For the first study two hundred fifty-three subjects were recruited. Of those, 21 participants obtained an SQD-Scores of the all tests were summed to provide an overall score for the HTQ with M = 1.505  for the test phase, and with M = 1.522  for the re-test, respectively. The mean score is very far from 2.5 that represent the threshold value, confirming the absence of a post-traumatic symptomatology. Scores on SQD were also summed to provide an overall score for both psychological distress  and depression .2120 = 1043.57, p.000) was run: it showed that a five-factors solution was the best model, with satisfactory indexes of fit .In Fig. Intrusion symptoms were saturated on Factor 1, alteration in arousal and reactivity on Factor 2 , negative alterations in cognition and mood on Factor 3 , and avoidance strategies on Factor 4 . A single item (5 “Inability to feel emotions” saturated on factor 5). This statement was frequently misunderstood, exhibiting a low endorsement and loading in other validation studies see , 27)..27]).p < 0.05) and a significant positive correlation with depression, as measured by the SQD-D . Conversely, the BES showed a very weak correlation with HTQ .The convergent and divergent validity of the HTQ was explored by calculating its Pearson correlations with well-established measures of PTSD  and depression , and binge eating disorder (BES), respectively. HTQ held a fair positive correlation with the SQD-P subscale , if we refer to the lower thresholds typically referenced by health professionals /d = (1.962 × .25 × .75)/.052 = 288.12. The result required a total of Participants for this study were recruited through contacts with the municipalities, by newspaper and online advertisements and notices requesting to provide contact information so that the research staff can reach them to review eligibility and discuss next step. The study used flyers and oral presentations at various sites to recruit participants; these sites included collaborating organizations, and diverse associations representing the earthquake’s victims of the. In three rural villages, the researcher first obtained permission from the local authorities, and then posted flyers. During a phone screen, study staff confirmed potential interest, eligibility answering any question the participant may have about the study. After checking the inclusion and exclusion criteria, the eligible subjects were scheduled for a consent visit for additional screening and confirm eligibility. The inclusion criteria were: 1) age (over 18 years); 2) possible use of drugs for the clinical disorders treatment ; 3) written informed consent; 4) residence and being during the earthquake of 2016 in one of the municipalities of Ascoli Piceno , Macerata , and Rieti . The exclusion criteria were: 1) presence of neurodegenerative diseases ; 2) occurrence of neuro-developmental disorders ; 3) participation in other clinical trial. Three hundred and ten potential participants were contacted and offered study participation; fifteen of them did not meet inclusion criteria, and seven declined to participate because of conflict with their work schedule. Thus, the sample of the present study was initially composed of 288 individuals. Written informed consent was obtained from all participants before performing any study procedures.To obtain more knowledge on the influence of earthquake on the individuals, we decided to include an additional questionnaire on the socio-demographic and earthquake-related factors, as well as a widely used assessment tool for PTSD symptoms. Questionnaire was constructed for the current research to assess exposures during the earthquakes, negative experiences from the earthquake and the impact of the earthquakes on the life. The questionnaire contained dichotomous or multiple-choice answers. The statements collected data on participant’s gender, year of birth, place of residence, educational qualification, marital status, profession, delocalization in the post-earthquake period, current housing situation, damage to houses, psychological diagnoses, current psychotherapy or pharmacological treatments, and life events suffered in the last year. The incorporated traumatic experiences during the earthquakes were seeing someone who were injured or killed, whether they assisted in rescue efforts and if family members (relatives or close family) were killed, injured, or trapped. The statements were based on previous traumatic exposure instruments and on consultations in the team of investigators with experience from the research field. Post-Traumatic Stress Related Symptoms (HTQ-PTSD-R) were measured by the Harvard Trauma Questionnaire (HTQ) Part IV , 21 and A psychology graduate (the second author) was trained at the Cognitive Psychology Laboratory in the Department of Medicine and Surgery of the University of Parma  to manage the HTQ and SQD tools with the earthquake victims. She administered the socio-demographic questionnaire (see Instruments and assessment paragraph) in a face-to-face interview to enrolled participants in the districts belonging Ascoli Piceno, Macerata, and Rieti. Data was collected from June and October 2018 approximately 20 months after the earthquakes within the frame of specific environments to protect the privacy of the participant (home administration or in structured contexts). After a verbal consent, each subject filled in the written informed consent. Afterwards, they responded to the socio-demographic interview, the HTQ, and the SQD. Each administration took approximately 10–30 min for completion and was held at the participants’ home or at a place where they felt comfortable as long as confidentiality was assured. Prior to the interview the researchers explained that it was likely that the socio-demographic and questionnaires’ affirmations would recall memories related to the events; therefore, participants could experience some discomfort or distress as a result. The information contained on the subjects’ information booklet was then explained and clarified. The participants were reminded that their information would be handled in agreement with ethical guidelines and confidential procedures, and that they could withdraw their collaboration at any time during or after the interview. The involved trial has been conducted in accordance with the Helsinki Declaration.All analyses were carried out using the statistical program R version 4.0.1; ROCit  and MuMiData obtained with individuals recruited from survivors were compared to those of the normative sample (one sample t-test). The sensitivity was calculated through the associations among the PTSD cases identified from the reference test (SQD-P) and those suggested from the HTQ test (chi - squared test). The impact of different socio-demographic and earthquake-related variables on HTQ scores was explored through backward stepwise logistic regressions to get the best predictors for PTSD. With the purpose to investigate the relationship between traumatic symptomatology and earthquake-related factors, during data processing, subjects were distributed according to the area of origin into three subgroups: 1) Red zone, where participants suffered additional traumatic experiences ; 2) Orange zone, with participants coming from the district of Macerata; 3) Yellow zone, whose members came from the Ascoli Piceno district.t-test: t280 = 14.406, p < .001; Cohen’s d = .681).The HTQ-PTSD-R average score of the sample exposed to the earthquake, obtained from raw scores following the guidelines of Mollica et al. , (M = 1.Table N = 49) was assessed as probably depressed. As seen in Fig. N = 61) of the sample is considered symptomatic of PTSD, followed by 19.9% who reported a partial PTSD (N = 56). Meanwhile, according to the SQD-P subscale the 28.5% (N = 80) of the sample showed a probable PTSD, and the 24.2% (N = 68) a partial PTSD. The diagnostic categories of SCD-P and HTQ emerged as associate , mainly the absence of PTSD  and its positive occurrence (z = 11.1),In this phase of the study, the average scores for HTQ and SQD-P sub-scale were 1.92 ± .61 (range = 1–3.80) and 3.93 ± 2.5 (range = 0–9), respectively. The SQD-D mean was 2.37 ± 1.8 (range = 0–6), and the 17.44% of the sample , as well as the zero-order correlation between HTQ total score and SQD-D ). However, despite the partial correlation HTQ-SQD-P, controlled for SQD-D, remained quite strong and significant , the partial correlation HTQ-SQD-D, controlled for SQD-P, disappeared .The zero-order correlation between HTQ total score and SQD-P subscale was positive and very good  and Hypervigilance  scales, and rather well to Avoidance  and Negative mood .The SQD-P scale was strongly related to the Intrusion  in a ROC analysis Fig.  for the χ2 = 21.98, p < .001, Hosmer-Lemeshow pseudo-R2 R2H-L = 0.059). Women appeared more exposed to the risk than men , while younger people were more secure than older ones . Proximity to epicentre significantly predicted the PTSD onset , only gender and age significantly predicted PTSD : the likelihood of developing symptoms was more than twice in people whose homes had been damaged , while it was halved in those who did not suffer from bereavement .Among the factors contemporary or immediately following the earthquake , home damage and bereavement were predictive of PTSD symptoms . The time spent away from home (but not the type of the relocation) had a significant effect : the likelihood of developing PTSD was significantly lower in people who could remain at home than in those who were taken away for 6–12 months  or more than a year , while it was analogous to the probability of who has been away for 3–6 months  and less than three months .Among the earthquake long-term consequences , the job loss was analysed separately, because it only applied to 151 participants (130 subjects were retirees or pre-earthquake unemployed). Analysis indicated that when participants did not lose their jobs, there was less probability to evolve PTSD  and the time spent away from home (w = 0.359).The model selection . The correlation between HTQ and SQD-P was higher, with a great index result (r = 0.85). The HTQ showed a convergent validity like that of SQD-P subscale. Furthermore, findings suggested a good correlation between HTQ and the SQD-D subscale (r = 0.71), due to the HTQ items 4, 5, 12, 13 and 14 that addressed negatives mood and cognitions.In conclusion, the Cronbach alpha of the Italian version of the Harvard Trauma Questionnaire , 21 (a =The primary aim was to assess the prevalence of PTSD among the adult survivors of the earthquake of 24 August 2016. The issue of psychiatric morbidity after the earthquake needs to be explored to promote positive mental health among the earthquake victims. An important finding of the present investigation is that two years after a devastating earthquake, PTSD is prevalent among the 21.71% of the adult survivors and that this value does not differ so much from the mean percentage of 23.66% reported by the literature . This suIn detail, our data indicated a higher PTSD prevalence in the red zone compared to the other two zones, an outcome firstly anticipated, since the red zone was the epicenter and suffered extensive damage, loss of life and misplacement of entire municipalities. Our study confirmed the proximity to the epicenter as a risk factor ; being tAn earthquake has serious concerns on the quality of life for people directly exposed to the disaster and there are consequences that can increase the PTSD development and its chronic course. The consequences of the earthquake affected much more the survivors living near the epicenter revealing similar findings to previous investigations . Our stuOur study is not without limitations. The aims of this research were to assess the long-lasting post-traumatic responses of exposure to earthquake of different districts during 18 weeks of data collection period in 2018, thus it may not represent the whole survivors of earthquake in Central Italy. The sample size is rather modest. Study results recommend executing further larger sample in other settings for better generalization of the findings. Another shortcoming is that the distribution of the gender was not homogeneous, as women were more frequently represented in the sample. The administration of the instruments took place about two years from the earthquake, and the impact was revealed dissimilar according to the area: some countries restarted normal activities while other areas were still facing the management of the population in the SAE. A further limitation is not having explored the influence of social or family support, since it could affect personal resources in managing traumatic events. Additional drawback was that the inter-rater reliability of diagnoses could not be investigated. Therefore, it remains unclear to what extent these symptoms would correlate with formal clinical diagnoses based on the DSM or ICD. This had implications, as the sensitivity to change could not be examined against diagnoses based on structured clinical interviews. Hence, the possibility that the HTQ poses some bias in diagnosis should not be ignored, and the combination of self-reports and clinical-based criteria should be addressed in future. Finally, both Cronbach’s alpha values and the lack of correspondence between the previous revision  and our The current study adds to the growing literature supporting the validity of the HTQ as screening tools of PTSD, even if it would be better an integration with the additional items included in the HTQ-5 . An updaFirst, the HTQ is an easily administered screening tool with adequate psychometric properties, allowing practitioners to distinguish individuals who revealed trauma symptomatology. When a high number of victims are involved, it is essential to have fast screening questionnaires that identify possible pathologies addressing the suffering individuals to appropriate therapeutic pathways. In addition, the first items of the HTQ IV part is a useful instrument in the clinical or research field, specifying a severity score for each cluster, more than reporting the presence/absence of PTSD. This questionnaire does not require enormous healthcare costs and it is different from other more invasive tools. Overall, the HTQ can be useful in catastrophes with a high number of victims. The benefit of such a list would be a shorter time of administration that, in turn, would increase the number of individuals having access to professional care. Additionally, this investigation provides further evidence for the value of the scale in a new country, namely, Italy. In conclusion, the PTSD prevalence of 21.71% after two years from the earthquake should encourage Italian institutions to plan psychological intervention not only in the emergency period, but also for the population reintegration.


Employment improves mental health and well-being by providing financial security, daily structure, a sense of identity and purpose, and social engagement. However, securing and sustaining employment is exceptionally challenging for vulnerable populations who experience persistent and multiple barriers, such as mental illness, homelessness, food and housing insecurity, and marginalization. Evidence-based supported employment programs, most notably individual placement and support (IPS) are becoming a more common approach for addressing the needs of these high-risk individuals. The aim of this paper is to outline the protocol for evaluating an IPS program in Vancouver’s downtown and Downtown Eastside (DTES).This prospective quasi-experimental study of persons with persistent and multiple barriers to employment will use a mixed-methods approach for evaluating a novel IPS program. The evaluation will consist of survey packages and interviews that will capture outcomes related to employment and well-being, as well as the experiential process of receiving individualized and integrated supports through the IPS program. A mixed-methods approach is appropriate for this study as quantitative data will provide an objective assessment of program impacts on employment and well-being outcomes over time, while qualitative data will provide an in-depth understanding of continued barriers and experiences.The results from this evaluation will contribute evidence within a local British Columbian (BC) context that may increase access to meaningful employment for those with long-term experience of complex barriers to employment. Further, the findings will support continued improvements, and guide decision-making around practices and policy for future implementation of IPS and employment supports across BC. Unemployment rates in British Columbia (BC), Canada have risen from 4.7% in 2019 to 7.5% at the start of 2021 . SustainSupported employment refers to the assortment of programs and services available to help people with disability secure competitive work . IndividOne of the core principles of the IPS model is the intentional integration of employment services with broader mental health treatment . In CanaIn British Columbia, individuals who face a disproportionate number of barriers to employment may receive a designation by the Government as “persons with persistent and multiple barriers (PPMB).” Individuals with PPMB status have a persistent health condition, and may experience any combination of other health and social challenges including but not limited to homelessness or risk to homelessness, food insecurity, unsafe housing, and marginalisation, as well as need basic skills or language training for employment readiness . A healtOur overarching objective is to contribute new knowledge of IPS embedded within primary care to inform decision making, and guide practice and policy related to employment supports for vulnerable populations  across British Columbia. Specifically, our research aims are to:Assess the effectiveness of the IPS program for securing employment for individuals with PPMB status;Assess the impact of individualized and integrated primary care supports provided through the IPS program on health and social outcomes for individuals with PPMB status; andGain an understanding of the experiential process of the IPS program from individuals accessing the program, as well as from healthcare professionals and staff involved in its implementation.Links to Employment program provided through the Canadian Mental Health Association (CMHA) BC Division. In addition, this evaluation will investigate the implementation process of the IPS program, in order to improve program features and practices for future implementation, including anticipated program expansion. All components of this study have been approved by the University of British Columbia Behavioural Research Ethics Board (BREB) on March 17, 2021 (UBC BREB# H20-02198).This is an ongoing prospective quasi-experimental study that will run for 18 months from February 2021 to September 2022. The evaluation is designed as a mixed-methods process that will assess the impact on employment, health, and social, outcomes of the Links to Employment is a novel supported employment program targeted at promoting the well-being of vulnerable individuals within Metro Vancouver, British Columbia, a diverse city of 2.6 million people located on Canada’s west coast. Within Vancouver’s downtown core exists a neighborhood called the Downtown Eastside (DTES), often described as a community with a complex set of social issues including high levels of substance use, homelessness, poverty, and crime [Links to Employment program include time unlimited services, access to IPS trained and trauma informed program staff embedded within a primary care team, involvement of an integrated care team that includes clinicians located within the same primary care setting, and ongoing focus on health and well-being simultaneous to vocational support. Continued consideration of environmental needs , and mental and emotional well-being is also a critical component, given the vulnerability of the target population. By engaging a variety of professionals in a coordinated way, including a vocational counsellor, occupational therapist, job developer, case manager, and primary care providers, the program is able to provide greater integrated health services and supports to support individualized employment and health goals.nd crime . Our intLinks to Employment program is designed to support complex populations, primarily those who currently have little to low employment readiness, throughout their entire employment journey. This remains an unmet need for a large portion of those living or accessing services in the DTES. For this population, existing vocational services  targeted to those with moderate to high employment readiness are not sufficient or effective. Links to Employment is currently filling.The Links to Employment IPS program is operating out of two central sites located within primary care settings: The Three Bridges Community Health Centre located in Vancouver’s central downtown area and the REACH Community Health Centre located adjacent to Vancouver’s DTES.The Participants are eligible for this study if they are receiving or will be receiving employment supports through the IPS program. This includes individuals currently enrolled in the program, as well as those waitlisted. As such, eligibility is primarily based on eligibility criteria being met for enrollment in the IPS program; there is no other exclusion criteria for this study. To receive a referral to the program, all individuals must be considered eligible for PPMB status by a primary care physician. That is, individuals need to currently be experiencing a number of barriers to employment that are not expected to improve in the short-term. Qualifying barriers include, but are not limited to, a persistent health condition, homelessness or risk to homelessness, the need for basic skills or language training, a criminal record, food insecurity, unsafe housing, discrimination, and marginalisation . In addiIn addition to those enrolled in the IPS program, all healthcare providers and staff involved in the implementation of the program will be invited to participate in the research by providing their feedback and experience around the implementation process.To ensure consistency in recruitment, we have developed a recruitment protocol to engage clients in the IPS program for the research study. The initial introduction to the study is made through IPS program staff , who provide a brief summary of the study to their clients and seek permission for them to be contacted by research staff. If clients are interested, program staff also provide a copy of the detailed study information and blank consent form. Program staff them contact the research coordinator, who will contact clients via their preferred method of communication  within 1 week. All potential participants have multiple opportunities to engage with the research coordinator prior to providing their signed consent. A traditional (print) or digital signature is accepted.Sample size of participants will depend on the capacity of the IPS program, and client turnover within the program. Based on IPS fidelity standards , we antiGiven the observational nature of this study, there are no direct risks associated with participation, as individuals will continue along their natural employment service trajectories. While some of the questions included in the assessments may trigger negative feelings or discomfort for participants, we attempt to mitigate this by providing a list of local mental health resources and contacts alongside each assessment, as well as collaborating with their broader care team, as necessary.Given the complexity of the study population, current COVID-19 pandemic public health restrictions, and diverse nature of the research questions, a mixed-methods approach will be used for data collection. The quantitative assessments will be used to capture demographic characteristics about the population enrolled and waitlisted for the IPS program, as well as objectively measure their employment, health, and social outcomes over time. The qualitative assessments will be used to capture a more in-depth and detailed understanding of the experiential process, including program feedback, from those who received services/supports through the IPS program, as well as those involved with implementation. Drawing from multiple sources for data is a form of methodological triangulation that allows us to investigate different but complementary aspects of a phenomenon to gain a more exhausted understanding of it , 28. ForIn addition to data collection from those who participated in the IPS program, a subset of individuals who remain on the waitlist at 12 -months will complete an assessment of their current employment and well-being. All program participants will be compensated for their time, receiving an honorarium for each research activity completed up to a total of $200.00 Canadian.Service providers involved in the implementation of the IPS program will complete an open-ended survey. There will be no compensation for this activity.Data on socio-economic characteristics will be collected as part of the baseline assessment. This information includes but is not limited to age, sex at birth, gender, level of education, language(s) spoken, ethnicity, self-reported health condition, and current living situation.The primary outcome of interest is the proportion of study participants who secure employment over the course of one year. In addition to this, employment quality and sustainability will be assessed through both quantitative survey questions and qualitative interview questions. Participants will be asked to provide detailed information about their employment/training  and self-rate their employment satisfaction, as well as have the opportunity to provide their in-depth experiences and reflections around their current or past employment.Secondary outcomes of interest include measures of both health and social well-being over time. The GAD-7 , PHQ-9 , C-PROM To complement the employment, health, and social outcome data described above, qualitative data will be collected from both 1:1 semi-structured interviews (program participants) and open-ended survey questions, including questions about how PPMB status was determined (service providers). Program participants will have the option to complete their interview in-person, over the phone, or through the video conferencing system Zoom. Service providers will complete their survey electronically. The decision to use an open-ended survey rather than conduct interviews with service providers was based on the anticipated time commitment. The selected approach allows for capture of in-depth qualitative feedback with minimum disruption to workflow. Both instruments were developed based on existing evaluations for IPS and the IPS model, and discussed across a multi-disciplinary team to ensure contextual appropriateness.Links employment program; what key factors or supports or needed to help you achieve your short/long-term employment goals?; what do you feel are necessary supports for maintaining employment?. Sample questions/prompts from the open-ended survey for implementation staff include: In your opinion, what key factors are needed to maximize the employment/education potential of individuals with PPMB status over the long term?; how would you describe the implementation of this IPS program?.The qualitative data collected will provide a better understanding of how the IPS program was experienced and key strengths/weaknesses to its implementation, as well as continued barriers/gaps in supports. Sample questions/prompts from the interview guide for program participants include: Describe your experience with the Quantitative data will be analyzed using version 4.0.2 of R software: A language and environment for statistical computing . DescripQualitative data will be analyzed using version 12 of NVivo Pro . InterviThere is widespread recognition and a strong body of evidence that IPS is an effective approach for improving employment outcomes for those with severe mental illness , 15–18. There are potential limitations to this study protocol. First, the study is quasi-experimental rather than randomly controlled. Given the known needs of the population in Vancouver’s downtown and DTES, and pilot RCT work led by our team, there were ethical considerations around assigning high-risk individuals to traditional vocational services  that are not designed for people with severe mental illness , and proThe results of this study will be disseminated through a variety of different mediums targeted to our range of stakeholders  and audiences . Knowledge translation activities include but are not limited to academic publications and conference presentations, community and government reports, community engagement activities including World Cafés, and traditional medial/social media activities.In conclusion, the novel findings from this research will provide insights into the impact and effectiveness of IPS embedded within primary care. This will contribute to ongoing strategies and practices for addressing the employment and well-being needs of British Columbia’s most complex and vulnerable population. Additionally, findings will be used to inform decision making and guide policy around employment supports at local, provincial, and federal levels.


The reactivation of this fault occurred after the Mw 8.1 Iquique earthquake, and it seems to be connected to a N–S interplate locking segmentation of the plate margin, which is clearly shown by the locking pattern before the Iquique earthquake. This poses the question of how heterogeneous locking influences upper plate seismicity and how it relates to trench-parallel shortening.Quaternary deformation in the northern Chile forearc is controlled by trench parallel shortening along reactivated Mesozoic faults. Dextral strikes-slip is expressed in NW–SE striking faults of the Atacama Fault System, and reverse displacement dominates in E–W faults. This deformation results of the convergence in a concave-seaward continental margin. On September 11th, 2020, a M These observations have revealed that Interplate locking is fundamental for earthquake nucleation and earthquake propagation6. However, an unexplored aspect is how interplate locking can influence the earthquake generation in the upper plate. As, interplate locking is a transient property that is strongly dependent on the subduction earthquake cycle, the interlink between locking and the permanent deformation of the upper plate has remained unexplored. Sippl et al.7 presented a high-resolution relocation of upper plate earthquakes in northern Chile, detecting a clustered background seismicity in areas of low-interplate locking.Geodetic observations have shown with unprecedented details how plates are locked at subduction zones9, suggesting the contribution of the trench-parallel shortening to the Quaternary upper plate deformation . The depth location accuracy has been quantified for only the Mw 6.7 off-Iquique 2014 earthquake11. The rest of the other earthquakes were located sufficiently far from the interplate contact by at least 8 km  and the USGS (https://earthquake.usgs.gov/earthquakes/eventpage/us7000blm2/executive), which is characterized by trench-transverse nodal planes. The compressional character of the reported focal mechanisms for the mainshock clearly warns of the potential reactivation of upper faults by N–S shortening. In this contribution, we relocate the main earthquake and aftershocks to illuminate the rupture zone and calculated the moment tensor solution for the mainshock and aftershocks. Through these procedures, the determination of the stress condition present during the rupture and the aftershock phase was completed. The occurrence of this earthquake raises two fundamental questions about the ability of some trench orthogonal reverse faults of the Coastal Cordillera to be reactivated by the N–S compression and whether the reactivation of these faults is in some way related to the locking structure of the plate interface. The Cascadia subduction zone in the northwest of the North American Plate and also the Hokkaido segment in the northeastern Japan subduction zone are analogous in terms of the margin curvature of the Andean Orocline margin11. Therefore, the result of this contribution can add to a better understanding of the active faulting process in this type of curved margin, and in turn, studying this upper plate deformation may help us understand the plate interface regime.In northern Chile, several trench-orthogonal reverse faults and trench-oblique strike-slip faults of the Atacama Fault System are heavily expressed in the topographyion Fig. . Despite12. This gap partially ruptured during two recent earthquakes, i.e., the March 2014 Mw 8.1 Pisagua earthquake14 and the November 2007 Mw 7.7 Tocopilla earthquake15. Both earthquakes released nearly 20% of the slip deficit that had accumulated since the last large earthquake that occurred in northern Chile in 187714. Recently, Sippl et al.7 presented a summary of the seismicity of northern Chile between 2007 and 2014, illuminating in great detail the seismogenic structures present in northern Chile. According to this work, upper plate seismicity is widely distributed beneath the Coastal Cordillera near the Salar Grande, where the northern termination of the Atacama Fault System is located . This fault system was formed during the Early Cretaceous as a response to oblique convergence between the Phoenix Plate and the South American Plate5°S–20°S.21. GPS observations are based on survey mode (sGPS) and operated continuously (cGPS). Interseismic velocity is characterized by an ENE displacement of GPS sites parallel to the convergence velocity over the entire forearc area, being higher near the coastline and decreasing eastward . This interseismic pattern was transiently affected by the two large subduction earthquakes that occurred in northern Chile, the 2007 Mw 7.8 Tocopilla earthquake and the 2014 Mw 8.1 Iquique earthquake. Presently, the entire section of northern Chile is relocked, and a clear interseismic stage is well defined22.Northern Chile is densely covered by GPS stations of the Integrated Plate Boundary Observatory (IPOC), which is dedicated to the study of earthquakes and deformation of the active continental margin of Chile23 defined an along-strike segmentation of locking, which is characterized by a northern segment (Camarones Segment 19°S-20.16°S) separated from a southern segment (Loa Segment 20.4°S–22.4°S) by a low coupled zone near Iquique (20.15°S Iquique LCZ). A similar interplate-locking structure was resolved by the interseismic model of Hoffmann et al.22. In this model, the Iquique LCZ is located at 20.92°S–21.36°S, displaced southward with respect to the definition of the model of Metois et al.23. The epicentre of the 2020 Mw 6.3 Loa River earthquake was located above this low locked zone. Since the locking model of Hoffmann et al. uses three components  of interseismic velocities, the resolution of this model is more appropriate for the analysis of the interseismic velocity variation that we include in the discussion section.The image of interplate locking prior to the Iquique earthquake in northern Chile has been reproduced by several research groups Fig. . In partw 6.3 Loa River Earthquake occurred is well covered by seismic stations . We built a seismic catalogue including the principal event and 9 days of aftershock sequences, detecting a total of 83 aftershocks . When the arrival times were obtained, we relocated the events using the double-difference programme (HypoDD25) and the 1D velocity model of Husen et al.26. The final catalogue consists of 50 events . The focal mechanisms28, including nodal planes, slip vector and kinematic axes, were denoted by FaultKin software v.8.1.2 (http://www.geo.cornell.edu/geology/faculty/RWA/programs/faultkin.html).We determined the focal mechanisms of the 84 events using the polarities of the P-wave  and the SV/P, SH/P, and SH/SV amplitude ratios. The polarities were directly obtained from the vertical components of the seismograms for each station. As the polarities could be clearly detected, the use of a filter was unnecessary. The amplitude ratios were obtained from both the vertical and horizontal components filtered between 1 and 5 or 5–10 Hz. Based on the polarities and amplitude ratios, we computed the focal mechanisms for events with more than seven polarities using the FOCMEC programmew 6.3 earthquake is covered by four cGPS sites, CSRC, PB02, PB07 and PB03 . cGPS data later than 2018 are not available for all of these stations; therefore, our analysis does not cover the time when the Mw 6.3 earthquake occurred. Since the northern Chile region during this period was affected by the 2014 Mw 8.1 Iquique earthquake, we divided our analysis into two datasets. One dataset includes the period between February 28, 2008, and January 1, 2014. The other dataset includes the period between April 1, 2015, and January 1, 2018. With this strategy, we discarded the dataset affected by the preseismic stage and the afterslip of this earthquake. In the processing of the GPS data, we used the best possible two phases to minimize the error range. In the first phase, we used 24-h sessions of day-to-day GPS site positions, picking the ionosphere-free combination and fixing the ambiguities to integer values. We used precise orbits from the International GNSS Service (IGS) for Geodynamics31 and IGS Tables to describe the phase centres of the antennas. We estimated one tropospheric vertical delay parameter per station every 3 h. In the second phase, we produced daily time series by constraining regional stations unaffected by the earthquake to their well-recognized coordinates in the ITRF2014, such as KOUR in French Guyana; BRAZ, BRFT and CHPI in Brazil; RIO2 in Patagonia; and GLPS on the Nazca plate32. We utilized the linear trajectory method34 to model x(t), and the GPS daily position time series in the east, north, and up components are:i is the coefficient of polynomial functions of np maximum power, tR is a reference time defined as t0, B is the coefficient of H heaviside jumps to simulate earthquakes and nontectonic effects, C and D are the coefficients of a truncated Fourier series to account for seasonal variations mostly induced by the hydrological cycle , E is the coefficient of the transient postseismic logarithmic component, teq is the time of the Pisagua earthquake , and T is a constant determining the timescale of the logarithmic transient.The epicentral area of the MB03 Fig. , providiw 6.3; the main international agencies reported a moment magnitude (Mw) of 6.2 for this event. The Mw 6.3 earthquake was localized at a depth of 47 km immediately above the downdip limit of the seismogenic zone  located at the bottom of the upper plate near the plate interface. The alignment of the aftershocks in map view, as well as in a cross-section, shows the reactivation of a buried planar structure striking 315° and dipping 75° to the northeast. The aftershocks were distributed from a depth of 28 km down to near the interplate contact (Fig. According to our results, the mainshock and aftershock sequence of the Mact Fig. . To geom9. The fault trace of the Cerro Aguirre Fault is curved and composed of an E-W central segment and two bounding NW–SE and NE-SW fault segments in the eastern and western terminations of the fault trace, respectively (Fig. 9. Since the Miocene, this fault has been reactivated and has accumulated up to 130 m of vertical displacement, forming a prominent southward facing scarp (Fig. 36.One open question left by this earthquake sequence is whether there is some correlation between this sequence and the upper plate structure exposed at the topographic surface. Figure ely Fig. . The wesarp Fig. . The lon7; in this projection, the aftershocks alienate within a single zone of concentrated upper plate seismicity, which coincides with the interpreted projection of the Cerro Aguirre Fault in the section. The small deviation to the north of the cluster of aftershocks is due to our relocation method, which distributes the aftershocks with respect to the mainshock. Another source of uncertainty might be posed by the velocity model used, which does not resolve the uppermost levels of the crust in great detail. The profile in Fig. The Fig. 37. In these models, the trench parallel component of the interseismic velocity decreases towards the maximal plate curvature, generating trench-parallel shortening. Since the plate margin where the Mw 6.3 earthquake occurred forms a straight section, the reduction in the trench parallel component of the interseismic velocity, i.e., trench-parallel shortening, cannot be explained by the large-scale plate curvature of the southern Peru-northern Chile subduction margin (Fig. w 6.3 Loa River earthquake was caused by a reduction in the interseismic velocity due to along-strike variation in interplate locking (Fig. 22. The CRSC and PB02 sites are located in the area of low locking, whereas the PB07 and PB03 sites are situated in an area of higher interplate locking given by the Loa Segment (Fig. w 6.3 Loa River earthquake. One important aspect for validating this interpretation is whether the resolution of the locking model is sufficient to detect locking variation at the scale of distance between PB02 and PB07. This locking model is resolved with 1,016 triangular faults with an average of 170 km222. The centroids of each patch are at a distance of 13 km from each other. Sensitive analysis based on the checkerboard test22 indicates that interseismic locking is well resolved south of 19° at depths between 20 and 55 km. Since PB07 and PB02 are separated by a distance of 45 km, the locking model has sufficient resolution to explain the gradient in the interseismic velocity between these two sites.Theoretical models explain the trench parallel shortening in concave sea subduction zones as a result of interseismic deformation along a locked curved plate margingin Fig. . We postw 6.3 earthquake demonstrated the inelastic component of the upper plate deformation during the interseismic period. This behavior was generated by the occurrence of a pre-fractured crust, where optimally oriented older structures could be reactivated by the stress generated by plate interactions.Because PB02 and PB07 form a perfect baseline oriented perpendicular to the strike of the Cerro Aguirre Fault, the gradient in the northern component of the interseismic velocity, 2.8 ± 1.9 mm/year, between these two cGPS sites is a proxy of the loading rate of the Cerro Aguirre Fault. This conceptual model suggests that trench-parallel shortening occurred in a straight section of this plate margin where high and low locking patches coexist along strike. A relevant kinematic element of this model is the obliquity of the plate convergence velocity. This ensures the existence of a trench-parallel component of the interseismic velocity of the GPS sites situated above the coupling zone. The M38, and all of these models reproduced the same N-S locking variation characterized by two segments of high locking separated by an intersegment of low locking referred to as the Iquique low coupled zone. This intersegment acted as a barrier for the southern rupture of the Mw 8.1 Iquique earthquake revealing the occurrence of mechanical anisotropy dominated by rate strengthening in this zone. At this latitude, the bathymetry of the incoming Nazca Plate is dominated by the Iquique Ridge. The occurrence of this structure is a potential explanation for this low coupled zone; in fact, a previous work39 explained the occurrence of the southern barrier of the Iquique earthquake as controlled by the occurrence of seamounts. Seamounts can cause coupling reduction by aseismic slip and seismic swarms. The occurrence of the Iquique Ridge, controlling the first-order frictional properties of the interplate contact, suggests that these locking structures are probably expressed long term on this plate margin and controlling, to some extent, the upper plate deformation in northern Chile.The structure of interseismic locking in northern Chile before the Iquique earthquake has been modelled by several authorsw 6.3 Loa River earthquake was generated in the deep-seated portion of an orthogonal to the trench active upper plate fault zone, which is spatially linked to the Cerro Aguirre Fault. This fault represents a key structure of the upper plate marked by a prominent fault scarp at the surface, as well as a continuously downdip fault trace marked by seismicity. During the Mw 6.3 earthquake and its aftershock sequences, the fault zone slipped along a plane down from mid-crustal level at 28 km depth to 47–50 km near the subduction zone interface. This fault zone forms a sharp limit of the upper plate fault seismicity of the Coastal Cordillera, separating a northern zone with widely distributed upper plate seismicity from a southern zone devoid of crustal events. This segmentation is also expressed in the faulting configuration of the Coastal Cordillera; the region exposed north of the Cerro Aguirre Fault contains a large number of oblique to the trench and trench-orthogonal faults with a Quaternary faulting record, whereas these features do not exist southward. Therefore, we propose that the Cerro Aguirre Fault represents a complex upper plate structure forming an active segment boundary of the upper plate. The observed seismic reactivation of this fault zone is controlled by N–S shortening related to trench-parallel variation of the interplate locking.We demonstrate that the MSupplementary Figure S1.Supplementary Figure S2.Supplementary Figure S3.Supplementary Figure S4.Supplementary Figure S4.Supplementary Legends.Supplementary Table S1.Supplementary Table S2.