ABSTRACT
Aim This trial evaluated the efficacy of a CBT smartphone application (ClearlyMe®) for reducing depressive symptoms in adolescents when delivered with and without guidance and when compared to an active control.
Design An online three-arm, parallel-group randomised controlled trial. Ethical approval was provided by the University of New South Wales Human Research Ethics Committee.
Methods Adolescents in Australia aged 12 to 17 years with mild to moderate depressive symptoms as measured by the Patient Health Questionnaire-9 Adolescent version (PHQ-A) who were not receiving treatment or experiencing recent or severe suicidality, had access to a smartphone, and parental consent were randomly allocated to receive (i) self-directed use of ClearlyMe®, (ii) ClearlyMe® with SMS-guided support, or the active control (SMS-delivered psychoeducation content) for six weeks. Participants were not directly informed of their allocation and the statistician was blinded for analysis. Outcomes were assessed at baseline, post intervention (primary endpoint: 6-weeks post baseline) and follow-up (secondary endpoint: 4-months post baseline). Primary outcome was change in depressive symptoms from baseline to post intervention as measured by the PHQ-A. Intention-to-treat analyses used multilevel linear modelling.
Results 569 adolescents (Mean age: 15.89, SD: 1.26, 74.2% female) were included in the analyses. The declines in depressive symptoms post intervention in the self-directed (d=0.35, 95%CI:-0.57 – -0.12) and guided conditions (d=0.33, 95%CI: -.0.55 – -0.10) were significantly greater than the control. The effects of self-directed and guided were comparable. There were no differences between the conditions at follow-up for any outcomes. Secondary outcomes followed a similar pattern of change at both endpoints, although there were no differential effects for anxiety symptoms. The risk of adverse events was almost double in the control when compared to the self-directed (IRR: 1.73, 95%CI: 1.15 – 2.62, P=.009) and guided conditions (IRR: 1.98 (95%CI: 1.27 – 3.08, P=.002).
Conclusions ClearlyMe®, when delivered with or without SMS-guided support, was efficacious for short term reductions in depressive symptoms in adolescents when compared to SMS-delivered psychoeducation.
Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12622000131752). Universal Trial Number: U1111-1271-8519
Trial funding 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).
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
Data Availability
All data produced in the present study are available upon reasonable request to the authors.
