JMIR Publications

ABSTRACT

Background:

Internet-based cognitive-behavioural therapy (ICBT) is a newer studied treatment format that provides frontline treatment to adolescents with anxiety disorders.

Objective:

This study piloted procedures and obtained data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomised controlled trial (RCT) of the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns.

Methods:

Two-arm, multi-site, pilot RCT. Adolescents aged 13–17 years with a self-identified anxiety concern were recruited online, from health care settings, and from school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with limited telephone and e-mail support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety on the MASC2 from baseline to 8 weeks (post-treatment) in order to determine a sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of co-interventions, and health care resource use, including a cost-consequence analysis.

Results:

Of the 588 adolescents screened, 94 adolescents were eligible and enrolled in the study (49 adolescents were allocated to the Breathe group and 45 allocated to the control group). Analysis was based on 70/94 adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (standard deviation, SD: 1.2) and female (90.0%). The retention rates at 8 weeks were 28.3% (Breathe group) and 58.1% (control group). Fourteen (38.9%) adolescents provided feedback at the completion of the Breathe program. The mean satisfaction score among these adolescents was 28.5/40 (SD 4.0) indicating modest satisfaction. All but one adolescent indicated that the Breathe program was easy to use and that they had understood all the material presented within the program. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating a MCID or conducting a cost-consequence analysis were insufficient due to a low participant response rate.

Conclusions:

Adolescents were moderately satisfied with the Breathe program. However, program adjustments are needed to address attrition during program use and reduce adolescents’ perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program will be feasible if protocol adjustments are made to improve the study’s recruitment and retention rates to ensure timely study completion and increase the completeness of the data at each outcome measurement time-point. Clinical Trial: clinicaltrials.gov NCT02059226