Increasing Access to Mental Health Care With Breathe, an Internet Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial
Background There is a demand to make first line treatments, including cognitive behavioural therapy (CBT) for adolescent anxiety disorders, more widely available. Internet based CBT is proposed to circumvent access and availability barriers and reduce health care system costs. Recent reviews suggest more evidence is needed to establish the treatment effects of Internet based CBT in children and adolescents and to determine related economic impacts. Objective This pilot trial aims to collect the necessary data to inform the planning of a full scale RCT to test the effectiveness of the Internet based CBT program Breathe (Being Real, Easing Anxiety: Tools Helping Electronically) Methods We are conducting a 27 month, 2 arm parallel group, pilot randomized controlled trial (RCT) Outcomes will inform the planning of a full scale RCT aimed to test the effectiveness of Internet based CBT with a population of adolescents with moderate to mild anxiety problems. In the pilot RCT we will: (1) define a minimal clinically important difference (MCID) for the primary outcome measure (total anxiety score using the Multidimensional Anxiety Scale for Children) (2) determine a sample size for the full scale RCT; (3) estimate recruitment and retention rates; (4) measure intervention acceptability to inform critical intervention changes; (5) determine the use of co interventions; and (6) conduct a cost consequence analysis to inform a cost effectiveness analysis in the full scale RCT. Adolescents aged 13 17 years seeking care for an anxiety complaint from a participating emergency department, mobile or school based crisis team, or primary care clinic are being screened for interest and eligibility. Enrolled adolescents are being randomly allocated to either 8 weeks of Internet based CBT with limited telephone and e mail support, or a control group with access to a static webpage listing anxiety resources. Adolescents are randomly assigned using a computer generated allocation sequence. Data are being collected at baseline, treatment completion, and at a 3 month follow up. Results Currently, adolescents are being enrolled in the study. Enrolment is taking place between March 2014 and February 2016; data collection will conclude May 2016. We expect that analysis and results will be available by August 2016. Conclusions In many communities, the resources available for front line anxiety treatment are outweighed by the need for care. This pilot RCT is an essential step to designing a robust RCT to evaluate the effectiveness of an Internet based CBT program for adolescents with moderate to mild anxiety problems. Trial Registration Clinicaltrials.gov NCT02059226; http:/clinicaltrials.gov/ct2/show/NCT02059226 (Archived by WebCite at http:/www.webcitation.org/6epF8v7k4)
JMIR research protocols