Daily electronic monitoring of subjective and objective measures of illness activity in bipolar disorder using smartphones– the MONARCA II trial protocol: a randomized controlled single-blind parallel-group trial Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial. Using Smartphones to Monitor Bipolar Disorder Symptoms: A Pilot Study Daily electronic self-monitoring of subjective and objective symptoms in bipolar disorder—the MONARCA trial protocol (MONitoring, treAtment and pRediCtion of bipolAr disorder episodes): a randomised controlled single-blind trial Design and implementation of a randomized trial evaluating systematic care for bipolar disorder. Association between bipolar spectrum features and treatment outcomes in outpatients with major depressive disorder. Online psycho-education to the treatment of bipolar disorder: protocol of a randomized controlled trial Psychosocial disability in the course of bipolar I and II disorders: a prospective, comparative, longitudinal study. Long-term effectiveness and cost of a systematic care program for bipolar disorder. Augmenting psychoeducation with a mobile intervention for bipolar disorder: a randomized controlled trial. A randomized controlled trial of cognitive therapy for bipolar disorder: focus on long-term change. Appreciation of research information in patients with bipolar disorder. Voice analysis as an objective state marker in bipolar disorder Antidepressant-induced mania in bipolar patients: identification of risk factors. Patterns of pharmacological maintenance treatment in a community mental health services bipolar disorder cohort study (SIN-DEPRES). Self-monitoring and psychoeducation in bipolar patients with a smart-phone application (SIMPLe) project: design, development and studies protocols Adjunctive psychosocial intervention following Hospital discharge for Patients with bipolar disorder and comorbid substance use: A pilot randomized controlled trial
Background Patients with bipolar disorder often show decreased adherence with mood stabilizers and frequently interventions on prodromal depressive and manic symptoms are delayed . Recently , the MONARCA I r and omized controlled trial investigated the effect of electronic self-monitoring using smartphones on depressive and manic symptoms . The findings suggested that patients using the MONARCA system had more sustained depressive symptoms than patients using a smartphone for normal communicative purpose s , but had fewer manic symptoms during the trial . It is likely that the ability of these self-monitored measures to detect prodromal symptoms of depression and mania may be insufficient compared to automatically generated objective data on measures of illness activity such as phone usage , social activity , physical activity , and mobility . The Monsenso system , for smartphones integrating subjective and objective measures of illness activity was developed and will be tested in the present trial . Methods The MONARCA II trial uses a r and omized controlled single-blind parallel-group design . Patients with bipolar disorder according to ICD-10 who previously have been treated at the Copenhagen Clinic for Affective Disorder , Denmark are included and r and omized to either daily use of the Monsenso system including an feedback loop between patients and clinicians ( the intervention group ) or to the use of a smartphone for normal communicative purpose s ( the control group ) for a 9-month trial period . The trial was started in September 2014 and recruitment is ongoing . The outcomes are : differences in depressive and manic symptoms ; rate of depressive and manic episodes ( primary ) ; automatically generated objective data on measures of illness activity ; number of days hospitalized ; psychosocial functioning ( secondary ) ; perceived stress ; quality of life ; self-rated depressive symptoms ; self-rated manic symptoms ; recovery ; empowerment and adherence to medication ( tertiary ) between the intervention group and the control group during the trial . Ethical permission has been obtained . Positive , neutral and negative findings will be published . Discussion If the system is effective in reducing depressive and /or manic symptoms ( and other symptoms of bipolar disorder ) and the rate of episodes , there will be basis for extending the use to the treatment of bipolar disorder in general and in larger scale . Trial registration Clinical Trials.gov NCT02221336 . Registered 26th of September 2014 BACKGROUND The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence . Nevertheless , the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a r and omized controlled trial ( RCT ) . The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder . METHOD A total of 78 patients with bipolar disorder according to ICD-10 criteria , aged 18 - 60 years , and with 17-item Hamilton Depression Rating Scale ( HAMD-17 ) and Young Mania Rating Scale ( YMRS ) scores ≤17 were r and omized to the use of a smartphone for daily self-monitoring including a clinical feedback loop ( the intervention group ) or to the use of a smartphone for normal communicative purpose s ( the control group ) for 6 months . The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS , respectively , between the intervention and control groups . RESULTS Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones  on depressive as well as manic symptoms . There was a tendency towards more sustained depressive symptoms in the intervention group ( B = 2.02 , 95 % confidence interval -0.13 to 4.17 , p = 0.066 ) . Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group . CONCLUSIONS These results highlight that electronic self-monitoring , although intuitive and appealing , needs critical consideration and further clarification before it is implemented as a clinical tool Background Relapse prevention in bipolar disorder can be improved by monitoring symptoms in patients ' daily life .  Smartphone apps are easy-to-use , low-cost tools that can be used to assess this information . To date , few studies have examined the usefulness of smartphone data for monitoring symptoms in bipolar disorder . Objective We present results from a pilot test of a smartphone-based monitoring system , Social Information Monitoring for Patients with Bipolar Affective Disorder ( SIMBA ) , that tracked daily mood , physical activity , and social communication in 13 patients . The objective of this study was to investigate whether smartphone measurements predicted clinical symptoms levels and clinical symptom change . The hypotheses that smartphone measurements are ( 1 ) negatively related to clinical depressive symptoms and ( 2 ) positively related to clinical manic symptoms were tested . Methods Clinical rating scales were administered to assess clinical depressive and manic symptoms . Patients used a smartphone with the monitoring app for up to 12 months . R and om-coefficient multilevel models were computed to analyze the relationship between smartphone data and externally rated manic and depressive symptoms . Overall clinical symptom levels and clinical symptom changes were predicted by separating between-patient and within-patient effects . Using established clinical thresholds from the literature , marginal effect plots displayed clinical relevance of smartphone data . Results Overall symptom levels and change in clinical symptoms were related to smartphone measures . Higher overall levels of clinical depressive symptoms were predicted by lower self-reported mood measured by the smartphone ( beta=-.56 , P<.001 ) . An increase in clinical depressive symptoms was predicted by a decline in social communication ( ie , outgoing text messages : beta=-.28 , P<.001 ) and a decline in physical activity as measured by the smartphone ( ie , cell tower movements : beta=-.11 , P=.03 ) . Higher overall levels of clinical manic symptoms were predicted by lower physical activity on the smartphone ( ie , distance travelled : beta=-.37 , P<.001 ) , and higher social communication ( beta=.48 , P=.03 ) . An increase in clinical manic symptoms was predicted by a decrease in physical activity on the smartphone ( beta=-.17 , P<.001 ) . Conclusions Clinical symptoms were related to some objective and subjective smartphone measurements , but not all smartphone measures predicted the occurrence of bipolar symptoms above clinical thresholds . Thus , smartphones have the potential to monitor bipolar disorder symptoms in patients ’ daily life . Further validation of monitoring tools in a larger sample is needed . Conclusions are limited by the low prevalence of manic and depressive symptoms in the study sample . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 05663421 ; http://www.controlled-trials.com/IS RCT N05663421 ( Archived by WebCite at http://www.webcitation.org/6d9wsibJB Introduction Electronic self-monitoring of affective symptoms using cell phones is suggested as a practical and inexpensive way to monitor illness activity and identify early signs of affective symptoms . It has never been tested in a r and omised clinical trial whether electronic self-monitoring improves outcomes in bipolar disorder . We are conducting a trial testing the effect of using a Smartphone for self-monitoring in bipolar disorder . Methods We developed the MONARCA application for And roid-based Smartphones , allowing patients suffering from bipolar disorder to do daily self-monitoring — including an interactive feedback loop between patients and clinicians through a web-based interface . The effect of the application was tested in a parallel-group , single-blind r and omised controlled trial so far including 78 patients suffering from bipolar disorder in the age group 18–60 years who were given the use of a Smartphone with the MONARCA application ( intervention group ) or to the use of a cell phone without the application ( placebo group ) during a 6-month study period . The study was carried out from September 2011 . The outcomes were changes in affective symptoms ( primary ) , social functioning , perceived stress , self-rated depressive and manic symptoms , quality of life , adherence to medication , stress and cognitive functioning ( secondary and tertiary ) . Analysis Recruitment is ongoing . Ethics Ethical permission has been obtained . Dissemination Positive , neutral and negative findings of the study will be published . Registration details The trial is approved by the Regional Ethics Committee in The Capital Region of Denmark ( H-2 - 2011 - 056 ) and The Danish Data Protection Agency ( 2013 - 41 - 1710 ) . The trial is registered at Clinical Trials.gov as NCT01446406 OBJECTIVES Everyday care of bipolar disorder typically falls short of evidence -based practice . This report describes the design and implementation of a r and omized trial evaluating a systematic program to improve quality and continuity of care for bipolar disorder . METHODS Computerized records of a large health plan were used to identify all patients treated for bipolar disorder . Following a baseline diagnostic assessment , eligible and consenting patients were r and omly assigned to either continued usual care or a multifaceted intervention program including : development of a collaborative treatment plan , monthly telephone monitoring by a dedicated nurse care manager , feedback of monitoring results and algorithm-based medication recommendations to treating mental health providers , as-needed outreach and care coordination , and a structured psychoeducational group program ( the Life Goals Program by Bauer and McBride ) delivered by the nurse care manager . Blinded assessment s of clinical outcomes , functional outcomes , and treatment process were conducted every 3 months for 24 months . RESULTS A total of 441 patients ( 64 % of those eligible ) consented to participate and 43 % of enrolled patients met criteria for current major depressive episode , manic episode , or hypomanic episode .  An additional 39 % reported significant subthreshold symptoms , and 18 % reported minimal or no current mood symptoms . Of patients assigned to the intervention program , 94 % participated in telephone monitoring and 70 % attended at least one group session . CONCLUSIONS In a population -based sample of patients treated for bipolar disorder , approximately two-thirds agreed to participate in a r and omized trial comparing alternative treatment strategies . Nearly all patients accepted regular telephone monitoring and over two-thirds joined a structured group program . Future reports will describe clinical effectiveness and cost-effectiveness of the intervention program compared with usual care CONTEXT It has been suggested that patients with major depressive disorder ( MDD ) who display pretreatment features suggestive of bipolar disorder or bipolar spectrum features might have poorer treatment outcomes . OBJECTIVE To assess the association between bipolar spectrum features and antidepressant treatment outcome in MDD . DESIGN Open treatment followed by sequential r and omized controlled trials . SETTING Primary and specialty psychiatric outpatient centers in the United States . PARTICIPANTS Male and female out patients aged 18 to 75 years with a DSM-IV diagnosis of nonpsychotic MDD who participated in the Sequenced Treatment Alternatives to Relieve Depression ( STAR*D ) study . INTERVENTIONS Open treatment with citalopram followed by up to 3 sequential next-step treatments . MAIN OUTCOME MEASURES Number of treatment levels required to reach protocol -defined remission , as well as failure to return for the postbaseline visit , loss to follow-up , and psychiatric adverse events . For this secondary analysis , putative bipolar spectrum features , including items on the mania and psychosis subscales of the Psychiatric Diagnosis Screening Question naire , were examined for association with treatment outcomes . RESULTS Of the 4041 subjects who entered the study , 1198 ( 30.0 % ) endorsed at least 1 item on the psychosis scale and 1524 ( 38.1 % ) described at least 1 recent maniclike/hypomaniclike symptom . Irritability and psychoticlike symptoms at entry were significantly associated with poorer outcomes across up to 4 treatment levels , as were shorter episodes and some neurovegetative symptoms of depression . However , other indicators of bipolar diathesis including recent maniclike symptoms and family history of bipolar disorder as well as summary measures of bipolar spectrum features were not associated with treatment resistance . CONCLUSION Self-reported psychoticlike symptoms were common in a community sample of out patients with MDD and strongly associated with poorer outcomes . Overall , the data do not support the hypothesis that unrecognized bipolar spectrum illness contributes substantially to antidepressant treatment resistance Background Bipolar disorder patients frequently present recurrent episodes and often experience subsyndromal  symptoms  ,  cognitive impairment and difficulties in functioning  , with a  low quality of life , illness relapses and recurrent hospitalization . Early diagnosis and appropriate intervention may play a role in preventing neuroprogression in this disorder . New technologies represent an opportunity to develop st and ardized psychological treatments using internet-based tools that overcome some of the limitations of face-to-face treatments , in that they are readily accessible and the timing of therapy can be tailored to user needs and availability . However , although many psychological programs are offered through the web and mobile devices for bipolar disorder , there is a lack of high quality evidence concerning their efficacy and effectiveness due to the great variability in measures and methodology used . Methods This clinical trial is a simple-blind r and omized trial within a European project to compare an internet-based intervention with treatment as usual .  Bipolar disorder patients are to be included and r and omly assigned to one of two groups : 1 ) the experimental group ( tele-care support ) and 2 ) the control group . Participants in both groups will be evaluated at baseline ( pre-treatment ) and post-treatment . Discussion This study describes the design of a clinical trial based on psychoeducation intervention that may have a significant impact on both prognosis and treatment in bipolar disorder . Specifically , bringing different services together ( service aggregation ) , it is hoped that the approach proposed will significantly increase the impact of information and communication technologies on access and adherence to treatment , quality of the service , patient safety , patient and professional satisfaction , and quality of life of patients .Trial registration NCT02924415 . Retrospectively registered 27 September CONTEXT Evidence of psychosocial disability in bipolar disorder is based primarily on bipolar I disorder ( BP-I ) and does not relate disability to affective symptom severity and polarity or to bipolar II disorder ( BP-II ) . OBJECTIVE To provide detailed data on psychosocial disability in relation to symptom status during the long-term course of BP-I and BP-II . DESIGN A naturalistic study with 20 years of prospect i ve , systematic follow-up . SETTING Inpatient and outpatient treatment facilities at 5 US academic centers . Patients One hundred fifty-eight patients with BP-I and 133 patients with BP-II who were followed up for a mean ( SD ) of 15 ( 4.8 ) years in the National Institute of Mental Health Collaborative Depression Study . MAIN OUTCOME MEASURES The relationship , by r and om regression , between Range of Impaired Functioning Tool psychosocial impairment scores and affective symptom status in 1-month periods during the long-term course of illness from 6-month and yearly Longitudinal Interval Follow-up Evaluation interviews . RESULTS Psychosocial impairment increases significantly with each increment in depressive symptom severity for BP-I and BP-II and with most increments in manic symptom severity for BP-I. Subsyndromal hypomanic symptoms are not disabling in BP-II , and they may even enhance functioning . Depressive symptoms are at least as disabling as manic or hypomanic symptoms at corresponding severity levels and , in some cases , significantly more so . At each level of depressive symptom severity , BP-I and BP-II are equally impairing . When asymptomatic , patients with bipolar disorder have good psychosocial functioning , although it is not as good as that of well controls . CONCLUSIONS Psychosocial disability fluctuates in parallel with changes in affective symptom severity in BP-I and BP-II . Important findings for clinical management are the following : ( 1 ) depressive episodes and symptoms , which dominate the course of BP-I and BP-II , are equal to or more disabling than corresponding levels of manic or hypomanic symptoms ; ( 2 ) subsyndromal depressive symptoms , but not subsyndromal manic or hypomanic symptoms , are associated with significant impairment ; and ( 3 ) subsyndromal hypomanic symptoms appear to enhance functioning in BP-II CONTEXT Despite the availability of efficacious treatments , the long-term course of bipolar disorder is often unfavorable . OBJECTIVE To test the effectiveness of a multicomponent intervention program to improve the quality of care and long-term outcomes for persons with bipolar disorder . DESIGN R and omized controlled trial with allocation concealment and blinded outcome assessment . SETTING Mental health clinics of a group-model prepaid health plan . PATIENTS Of 785 patients in treatment for bipolar disorder who were invited to participate , 509 attended an evaluation appointment , 450 were found eligible to participate , and 441 enrolled in the trial . INTERVENTIONS Participants were r and omly assigned to a multicomponent intervention program or to continued care as usual . Three nurse care managers provided a 2-year systematic intervention program , including the following : a structured group psychoeducational program , monthly telephone monitoring of mood symptoms and medication adherence , feedback to treating mental health providers , facilitation of appropriate follow-up care , and as-needed outreach and crisis intervention . MAIN OUTCOME MEASURES In-person blinded research interviews every 3 months assessed mood symptoms using the Longitudinal Interval Follow-up Examination . Health plan administrative records were used to assess the use and cost of mental health services . RESULTS Intent-to-treat analyses demonstrated that the intervention significantly reduced the mean level of mania symptoms ( z = 2.09 , P = .04 ) and the time with significant mania symptoms ( 19.2 vs 24.7 weeks ; F(1 ) = 6.0 , P = .01 ) . There was no significant intervention effect on mean level of depressive symptoms ( z = 0.19 , P = .85 ) or time with significant depressive symptoms ( 47.6 vs 50.7 weeks ; F(1 ) = 0.56 , P = .45 ) . Benefits of the intervention were found only in a subgroup of 343 persons with clinical ly significant mood symptoms  at the baseline assessment . The incremental cost ( adjusted ) of the intervention was 1251 dollars ( 95 % confidence interval , 55 - 2446 dollars ) , including approximately 800 dollars for the intervention program services and an approximate 500 dollars increase in the costs of other mental health services . CONCLUSIONS Population -based systematic care programs can significantly reduce the frequency and severity of mania in bipolar disorder , and cost increases are modest considering the clinical gains . The incorporation of more specific cognitive and behavioral content or more effective medication regimens may be necessary to significantly reduce the symptoms of depression BACKGROUND Psychosocial interventions for bipolar disorder are frequently unavailable and re source intensive . Mobile technology may improve access to evidence -based interventions and may increase their efficacy . We evaluated the feasibility , acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms . METHODS This was a r and omized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either : 1 ) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies , or 2 ) paper- and -pencil mood monitoring . Participants were assessed at baseline , 6 weeks ( mid-point ) , 12 weeks ( post-treatment ) , and 24 weeks ( follow up ) with clinician-rated depression and mania scales and self-reported functioning . RESULTS Retention at 12 weeks was 93 % and both conditions were associated with high satisfaction . Compared to the paper- and -pencil condition , participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks ( Cohen׳s d for both were d=0.48 ) . However , these effects were not maintained at 24-weeks follow up . Conditions did not differ significantly in the impact on manic symptoms or functional impairment . LIMITATIONS This was not a definitive trial and was not powered to detect moderators and mediators . CONCLUSIONS Automated mobile-phone intervention is feasible , acceptable , and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder . However , sustainment of gains from symptom self-management  mobile interventions , once stopped , may be limited BACKGROUND This study reports the outcome of a r and omized controlled trial of cognitive therapy ( CT ) for bipolar disorder . The treatment protocol differed from other published forms of CT for bipolar disorder through the addition of emotive techniques . METHOD Fifty-two patients with DSM-IV bipolar I or II disorder were r and omly allocated to a 6-month trial of either CT or treatment as usual , with both treatment groups also receiving mood stabilizers . Outcome measures included relapse rates , dysfunctional attitudes , psychosocial functioning , hopelessness , self-control , and medication adherence . Patients were assessed during treatment by independent raters blind to the patients ' group status . RESULTS At posttreatment , patients allocated to CT had experienced less severe depression scores ( Beck Depression Inventory and Montgomery-Asberg Depression Rating Scale ) and less dysfunctional attitudes . After controlling for the presence of major depressive episode at baseline , there was a statistical trend toward a greater time to depressive relapse ( p=.06 ) for the CT group . At 12-month follow-up , the CT group showed a trend toward lower Young Mania Rating Scale scores and improved behavioral self-control . The Clinical Global Impressions-Improvement scale , comparing the 18 months prior to treatment to the severity of illness status at follow-up , showed a substantial difference between groups in favor of CT . CONCLUSION Our findings corroborate previous bipolar disorder research in demonstrating the value of CT , particularly immediately post-treatment , and indicate some continuation ( albeit diminishing ) of benefits in the succeeding 12 months . These findings suggest that psychological booster sessions may be crucial for maintaining the beneficial effects of cognitive therapy OBJECTIVE Ethicists have debated whether patients with serious mental illness can appreciate the risks of research participation and make autonomous decisions . We compared the abilities of euthymic and manic bipolar patients to appreciate and make voluntary decisions regarding  research participation . METHODS Twenty-six subjects with mania and 25 euthymic subjects review ed hypothetical consent forms for three research studies of varying risk . We assessed subjects ' appreciation of : their diagnosis and need for treatment ; the research er 's role ; the risks of participation ; and the degree of influence of family , the treating clinician , and payment on decisions to participate . RESULTS Most subjects ( 92 % ) agreed they had bipolar disorder requiring medication treatment . Subjects were less likely to participate in riskier studies . About half of subjects erroneously believed that research ers would make decisions based solely on what would be the best care for them ( therapeutic misconception ) ; and in r and omized medication trials , they mistakenly believed they had improved chances of receiving one treatment over another . There were no differences between mood groups on these measures . Over half of subjects ( 59 % ) indicated that their mental health provider might influence them to participate in a study even when they did not want to , but most rejected a role for family in decision making . Payment was rated as having little impact on decisions to participate in research . CONCLUSION Mania does not substantially influence appreciation of research participation .  Subjects with bipolar disorder , regardless of mood state , are at risk for therapeutic misconception and optimistic bias . Special protections may be needed when mental health professionals approach their own patients to participate in research Changes in speech have been suggested as sensitive and valid measures of depression and mania in bipolar disorder . The present study aim ed at investigating ( 1 ) voice features collected during phone calls as objective markers of affective states in bipolar disorder and ( 2 ) if combining voice features with automatically generated objective smartphone data on behavioral activities ( for example , number of text messages and phone calls per day ) and  electronic self-monitored data ( mood ) on illness activity would increase the accuracy as a marker of affective states . Using smartphones , voice features , automatically generated objective smartphone data on behavioral activities  and  electronic self-monitored data  were collected from 28 out patients with bipolar disorder in naturalistic setting s on a daily basis during a period of 12 weeks . Depressive and manic symptoms were assessed using the Hamilton Depression Rating Scale 17-item and the Young Mania Rating Scale , respectively , by a research er blinded to smartphone data . Data were analyzed using r and om forest algorithms . Affective states were classified using voice features extracted during everyday life phone calls . Voice features were found to be more accurate , sensitive and specific in the classification of manic or mixed states with an area under the curve (AUC)=0.89 compared with an AUC=0.78 for the classification of depressive states . Combining voice features with automatically generated objective smartphone data on behavioral activities  and electronic self-monitored data  increased the accuracy , sensitivity and specificity of classification of affective states slightly . Voice features collected in naturalistic setting s using smartphones may be used as objective state markers in patients with bipolar disorder BACKGROUND Concerns about possible risks of switching to mania associated with antidepressants continue to interfere with the establishment of an optimal treatment paradigm for bipolar depression . METHOD The response of 44 patients meeting DSM-IV criteria for bipolar disorder to naturalistic treatment was assessed for at least 6 weeks using the Montgomery-Asberg Depression Rating Scale and the Bech-Rafaelson Mania Rating Scale . Patients who experienced a manic or hypomanic switch were compared with those who did not on several variables including age , sex , diagnosis ( DSM-IV bipolar I vs. bipolar II ) , number of previous manic episodes , type of antidepressant therapy used ( electroconvulsive therapy vs. antidepressant drugs and , more particularly , selective serotonin reuptake inhibitors [ SSRIs ] ) , use and type of mood stabilizers ( lithium vs. anticonvulsants ) , and temperament of the patient , assessed during a normothymic period using the hyperthymia component of the Semi-structured Affective Temperament Interview . RESULTS Switches to hypomania or mania occurred in 27 % of all patients ( N = 12 ) ( and in 24 % of the subgroup of patients treated with SSRIs [ 8/33 ] ) ; 16 % ( N = 7 ) experienced manic episodes , and 11 % ( N = 5 ) experienced hypomanic episodes . Sex , age , diagnosis ( bipolar I vs. bipolar II ) , and additional treatment did not affect the risk of switching . The incidence of mood switches seemed not to differ between patients receiving an anticonvulsant and those receiving no mood stabilizer . In contrast , mood switches were less frequent in patients receiving lithium ( 15 % , 4/26 ) than in patients not treated with lithium ( 44 % , 8/18 ; p = .04 ) . The number of previous manic episodes did not affect the probability of switching , whereas a high score on the hyperthymia component of the Semistructured Affective Temperament Interview was associated with a greater risk of switching ( p = .008 ) . CONCLUSION The frequency of mood switching associated with acute antidepressant therapy may be reduced by lithium treatment . Particular attention should be paid to patients with a hyperthymic temperament , who have a greater risk of mood switches Maintenance therapy in bipolar disorder ( BD ) is usually required to prevent relapses and improve residual symptoms . Therefore , in this study , we describe patterns of pharmacological maintenance treatment and identify associated clinical features . This prospect i ve multicentre epidemiological study recruited a cohort of 739 consecutive out- patients with clinical ly stable BD . Clinical stability was assessed at baseline with the Clinical Global Impression scale for BD and depressive symptoms with the Hamilton Depression Rating Scale .  Psychotropic medications were classified and analysed according to their mechanism as well as use . Logistic regression models were used to examine the associations between pharmacological strategies and clinical features . Longer time since last episode [ odds ratio ( OR ) 1.002 , p < 0.0001 ] and family history of psychiatric disorders ( OR 1.911 , p = 0.028 ) were associated with lithium in monotherapy ;  manic polarity of the most recent episode ( OR 3.300 , p = 0.006 ) and longer duration of clinical stability ( OR 1.009 , p = 0.034 ) with antipsychotic in monotherapy ;  depressive polarity of the most recent episode ( OR 2.567 , p = 0.003 ) and bipolar II disorder diagnosis ( OR 2.278 , p = 0.008 ) with antidepressant combination ;  no ongoing psychiatric co-morbidity ( OR 0.230 , p = 0.004 ) with lithium and anticonvulsant ;  manic polarity of the most recent episode ( OR 3.774 , p < 0.0001 ) with lithium and antipsychotic ;  manic polarity of the most recent episode ( OR 2.907 , p = 0.028 ) with lithium , anticonvulsant and antipsychotic . The pharmacological patterns followed published recommendations , except for the excessive use of antidepressants . This study reveals clinical factors closely related to prescription patterns Background New technologies have recently been used for monitoring signs and symptoms of mental health illnesses and particularly have been tested to improve the outcomes in bipolar disorders . Web-based psychoeducational programs for bipolar disorders have also been implemented , yet to our knowledge , none of them have integrated both approaches in one single intervention . The aim of this project is to develop and vali date a smartphone application to monitor symptoms and signs and empower the self-management of bipolar disorder , offering customized embedded psychoeducation contents , in order to identify early symptoms and prevent relapses and hospitalizations . Methods / design The project will be carried out in three complementary phases , which will include a feasibility study ( first phase ) , a qualitative study ( second phase ) and a r and omized controlled trial ( third phase ) comparing the smartphone application ( SIMPLe ) on top of treatment as usual with treatment as usual alone . During the first phase , feasibility and satisfaction will be assessed with the application usage log data and with an electronic survey . Focus groups will be conducted and technical improvements will be incorporated at the second phase . Finally , at the third phase , survival analysis with multivariate data analysis will be performed and relationships between socio-demographic , clinical variables and assessment s scores with relapses in each group will be explored . Discussion This project could result in a highly available , user-friendly and not costly monitoring and psychoeducational intervention that could improve the outcome of people suffering from bipolar disorders in a practical and secure way . Trial registration Clinical Trials.gov : NCT02258711 ( October 2014 ) Bipolar disorder and substance use disorders are highly debilitating conditions , and especially when co-occurring , are associated with a variety of negative outcomes . Surprisingly , there is a relative lack of research on feasible and effective psychosocial treatments for individuals with comorbid bipolar and substance use disorder ( BD-SUD ) , and a dearth of literature examining interventions design ed specifically to improve outcomes such as symptoms , functioning , and treatment engagement/adherence following psychiatric hospitalization in this population . In the current paper , we report results of a pilot r and omized controlled trial ( n=30 ) , comparing the recently developed Integrated Treatment Adherence Program , which includes individual and telephone sessions provided to patients and their significant others , versus Enhanced Assessment and Monitoring for those with BD-SUD . Participants who received the Integrated Treatment Adherence Program demonstrated significantly faster and greater improvements in depression , mania , functioning , and values-consistent living than participants r and omized to Enhanced Assessment and Monitoring , and there was a trend for increased treatment adherence over time . Results are discussed in light of existing literature and study limitations , and suggestions for future research are proposed
Taken together , the literature presented in this dissertation illustrates that 1 ) smartphone-based electronic self-monitoring of mood  seems to reflect clinical ly assessed depressive and manic symptoms and enables the long-term characterization of mood instability in bipolar disorder ; 2 ) preliminary results suggest that smartphone-based automatically generated data ( e.g. the number of text messages sent/day ; the number of incoming and outgoing calls/day ; the number of changes in cell tower IDs/day ; and voice features ) seem to reflect clinical ly assessed depressive and manic symptoms in bipolar disorder ; 3 ) smartphone-based electronic self-monitoring had no effects on the severity of depressive and manic symptoms in bipolar disorder , according to a r and omized controlled trial ; and 4 ) electronic  monitoring of psychomotor activity and heart rate variability seems to reflect illness activity in bipolar disorder and differentiate between patients with bipolar disorder and healthy control individuals .
These findings point toward the usefulness of  electronic monitoring  as a marker of illness in bipolar disorder .
Major reasons for the insufficient effects of current treatment options in bipolar disorder include delayed intervention for prodromal depressive and manic symptoms and decreased adherence to psychopharmacological treatment .
The reliance on subjective information and clinical evaluations when diagnosing and assessing the severity of depressive and manic symptoms calls for less biased and more objective markers .
By using electronic devices , fine-grained data on complex psychopathological aspects of bipolar disorder can be evaluated unobtrusively over the long term .
Using electronic monitoring as a treatment intervention could provide innovative and novel interventions on-dem and with a potential global reach , filling the gap between availability and the need for treatment .