An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial

Abstract

Background Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders. Objective This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns. Methods This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email 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 from baseline to 8 weeks (posttreatment), which was used to determine the 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 cointerventions, and health care resource use, including a cost-consequence analysis. Results Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents’ scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. 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 an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks. Conclusions Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point. Trial Registration ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.

Digital interventions in mental health: evidence syntheses and economic modelling

“…As a result of the updated literature search, we identified 10 additional studies that met the inclusion criteria of our review and had been published over the preceding 2 years, [113][114][115][116][117][118][119][120][121][122] as shown in Figure 7. All 10 additional studies used DIs based on CBT delivered via the web/internet 113,114,[116][117][118][119]121,122 or via VR 120 or a mobile app. 115 One study used a non-CBT DI (progressive muscle relaxation).…”

“…115 One study used a non-CBT DI (progressive muscle relaxation). 119 The comparators against which the DIs were evaluated included NI, 114,115,117,[120][121][122] non-therapeutic controls 118 and NoDIs including face-to-face CBT. 113,116,119 With the exception of one study that recruited adolescents with anxiety, 118 the rest related to adult populations with depression, [113][114][115][116] mixed depression and anxiety, 122 social anxiety, 121 OCD, 119 paranoia in psychosis 120 and stress-related disorders (i.e.…”

“…adjustment disorder and exhaustion disorder). 117 The evaluations were conducted across six high-income countries: two in Germany, 113,114 three in the Netherlands, 115,116,120 one in Sweden, 117 one in Canada, 118 one in Australia 119 and two in the UK. 121,122 One study was a model-based economic evaluation 113 and the other nine used within-trial analyses.…”

“…121,122 One study was a model-based economic evaluation 113 and the other nine used within-trial analyses. [114][115][116][117][118][119][120][121][122] It is worth noting that one within-trial analysis 119 used a direct comparison between two DIs (CBT and relaxation) from a two-arm RCT benchmarked against a third intervention (face-to-face CBT) in an indirect comparison with data from previous meta-analyses. The time horizon across the 10 studies ranged from 8 weeks 118 to 3 years.…”

“…The time horizon across the 10 studies ranged from 8 weeks 118 to 3 years. 113 The analytical framework used in the studies included CMA, 114 CCA, 118 CEA, 113,[115][116][117]119 CUA [115][116][117][120][121][122] and CBA. 119 The perspectives adopted were either societal 113,[115][116][117]119,120 or that of the health-care provider.…”