The following is a “protocol summary for a randomized controlled trial evaluating the effectiveness of a CBT-based smartphone application for improving mental health outcomes in adolescents: The MobiliseMe Study,” published in the November 2022 issue. Psychiatry Li et al.
Depression is a major factor in adolescent dysfunction, although treatment has been shown to be effective for some of them. The lack of cognitive behavioral therapy (CBT) mobile apps for adolescents is surprising, given their potential to help break down barriers to treatment acceptance and adherence. To fill this void, researchers created ClearlyMe®, a CBT smartphone app that provides self-guided, interactive therapy for depression and anxiety in adolescents. You can use ClearlyMe® on its own or as part of a ‘collection’ of 37 short lessons covering essential CBT principles.
Investigators provide strategy for a randomized controlled study to compare ClearlyMe® with and without guided support for attention-congruent control in terms of its effects on depressive symptoms and secondary outcomes such as engagement, anxiety, and well-being. For this study, they hope to enroll 489 depressed youth between the ages of 12 and 17. Study participants will be assessed for eligibility, undergo a baseline assessment, and then be randomly assigned to ClearlyMe® (self-directed use) and ClearlyMe. ® Guided SMS support (guided use), or digital psychoeducation (attention-matched control). Approximately 6 weeks (primary endpoint) and 4 months (secondary endpoint) after baseline will be used to assess improvement in depressive symptoms and other outcomes (secondary endpoint). Additionally, 6-weeks after baseline, the study team will further assess engagement.
6 weeks post-baseline mean acquisition, adherence, and completion. Intention-to-treat analyzes using mixed-effects linear modeling will be conducted to assess whether ClearlyMe®-treated conditions show greater reductions in depressive symptoms and secondary outcomes than control conditions at 6 and 4 weeks after baseline. Participants reporting suicidal ideation at baseline, 6-week, and 4-month post-baseline assessments will have the option to receive a call from the team clinical psychologist and be prompted to use the Get Help section of the app to reduce their risk. This study represents a randomized controlled trial of a cognitive behavioral therapy (CBT) smartphone application for adolescent depression. Specifically, it will offer hard data on how ClearlyMe® affects depressive symptoms with and without guidance.