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

Background The effectiveness of Digital Cognitive Behavioural Therapy (dCBT) smartphone applications for reducing depressive symptoms in adolescents remain unclear.

An online three-arm, parallel-group randomised controlled trial evaluated the effectiveness of a CBT smartphone application (ClearlyMe®) 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®, ClearlyMe® 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). Outcomes 569 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: Cohen’s 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). Interpretation ClearlyMe®, 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. Funding: The Goodman Foundation and the Australian National Health and Medical Research Council Investigator Grants (MRF1197249, GNT2008839, GNT115614). Competing Interest Statement The ClearlyMe® app was developed and is owned by the Black Dog Institute, with the design and developed co-funded by a philanthropic donation from the Goodman Foundation. The MobiliseMe study was also supported by philanthropic funding from the Goodman Foundation and the National Health and Medical Research Council (NHMRC) Investigator Grants (BOD grant number MRF1197249, AWS grant number: GNT2008839, HC grant number GNT115614). Clinical Trial Australian New Zealand Clinical Trials Registry (ACTRN12622000131752). Universal Trial Number: U1111-1271-8519. Clinical Protocols https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383172&isReview=true Funding Statement The ClearlyMe® app was developed and is owned by the Black Dog Institute, with the design and developed co-funded by a philanthropic donation from the Goodman Foundation. The trial operations were funded by a philanthropic donation from the Goodman Foundation and investigators were funded by National Health and Medical Research Council Investigator Grants (BOD grant number MRF1197249, AWS grant number GNT2008839, HC grant number GNT115614). Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Human Research Ethics Committee of the University of New South Wales, Sydney, gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes This revision includes the following updates: (1) Inclusion of missingess analysis examining predictors of missingness and impact of missingness of primary effects. (2) Additional analysis testing intervention effects on PHQ-A at primary endpoint among those who were probable cases of MDD at baseline. (3) Updated data analysis section in Methods to account for this. Data Availability All data produced in the present study are available upon reasonable request to the authors.