The following is a summary of the “Protocol 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 of Psychiatry by Li et al.
Depression is a major factor in adolescents’ inability to function, although few of them are given the treatment that has been shown to be effective. The lack of cognitive behavioral therapy (CBT) mobile apps for teenagers is surprising, given their potential to help break down obstacles to treatment uptake and adherence. To fill this void, researchers created ClearlyMe®, a CBT smartphone app that provides adolescents with self-guided, interactive therapy for depression and anxiety. You can use ClearlyMe® on its own or as part of a ‘collection’ made up of 37 short lessons covering essential CBT principles.
Investigators provide the strategy for a randomized controlled study to compare ClearlyMe® with and without guided support to an attention-matched control in terms of its impact on depressive symptoms and secondary outcomes like engagement, anxiety, and well-being. With this study, they hope to enroll 489 depressed young people between the ages of 12 and 17. Study participants will be assessed for eligibility, take a baseline assessment, and then be randomly assigned to either ClearlyMe® (self-directed usage), ClearlyMe ® with guided SMS support (guided use), or digital psychoeducation (attention-matched control). About 6 weeks (principal endpoint) and 4 months (secondary endpoint) after baseline will be used to evaluate improvement in depressive symptoms and other outcomes (secondary endpoint). In addition, 6 weeks after the baseline, the study group will additionally evaluate engagement.
6 weeks post-baseline is defined as uptake, adherence, and completion. Intention-to-treat analyzes will be conducted using mixed-effects linear modeling to assess if ClearlyMe®-treated conditions show higher decreases in depression symptoms and secondary outcomes than control conditions 6 and 4 weeks after baseline. Participants who report suicidal ideation at the baseline, 6-week, and 4-month post-baseline assessments will have the option to get a call from the clinical psychologist team and will be urged to use the app’s Get Help section to reduce their risk. This study represents the first randomized controlled trial of a cognitive behavioral therapy (CBT) smartphone app for adolescent depression. Specifically, it will offer hard data on how ClearlyMe® affects depression symptoms with and without guidance.