The MobiliseMe study: A randomised controlled efficacy trial of a cognitive behavioural therapy smartphone application (ClearlyMe(R)) for reducing depressive symptoms in adolescents.

BackgroundThe effectiveness of Digital Cognitive Behavioural Therapy (dCBT) smartphone applications for reducing depressive symptoms in adolescents remain unclear. MethodsAn online three-arm, parallel-group randomised controlled trial evaluated the effectiveness of a CBT smartphone application (ClearlyMe(R)) for reducing depressive symptoms in adolescents with outcomes assessed at baseline, post intervention (primary endpoint: 6-weeks post baseline) and follow-up (secondary endpoint: 4-months post baseline). The University of New South Wales Human Research Ethics Committee provided ethical approval. Youth were eligible if they were aged 12 to 17 years, in Australia, had mild to moderate depressive symptoms as measured by the adolescent Patient Health Questionnaire-9 (PHQ-A), were not receiving treatment or experiencing recent or severe suicidality, had access to a smartphone, and parental consent. Participants were randomised to self-directed ClearlyMe(R), ClearlyMe(R) with SMS-guided support, or the attention-matched control. Participants were not directly informed of their allocation. The statistician was blinded for analysis. The primary outcome was PHQ-A change post intervention. Intention-to-treat analyses used mixed models for repeated measures. The trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12622000131752). Outcomes569 adolescents (Mean age: 15.89, SD: 1.26, 74.2% female) were included in the analyses. The self-directed and guided conditions showed significantly greater reductions in depressive symptoms post intervention than the control (self-directed: Cohens d=0.35, mean differential decline 1.77; 95%CI: 0.56 - 2.98; P=.004; guided: d=0.33, mean differential decline: 1.31; 95%CI: 0.12 - 2.49; P=.030). The effects of self-directed and guided were comparable. Effects were also more robust and substantially larger post intervention among adolescents with probable MDD at baseline. Secondary outcomes showed similar patterns of change, although no differential effects for anxiety. There were no differences between the conditions at follow-up for any outcomes. Risk of adverse events was almost double in controls compared to self-directed (IRR: 1.73, 95%CI: 1.15 - 2.62, P=.009) and guided (IRR: 1.98 (95%CI: 1.27 - 3.08, P=.002). InterpretationClearlyMe(R), self-directed or with SMS-guided support, was effective for the short-term reduction of depressive symptoms in adolescents who have mild to moderate depression and are not receiving any other treatment. FundingThe Goodman Foundation and the Australian National Health and Medical Research Council Investigator Grants (MRF1197249, GNT2008839, GNT115614).