Digital delivery of Behavioural Activation therapy to overcome depression and facilitate social and economic transitions of adolescents in South Africa (the DoBAt study): protocol for a pilot randomised controlled trial

Abstract

Introduction: Scalable psychological treatments to address depression amongst adolescents are urgently needed. This is particularly relevant to low- and middle-income countries where 90% of the world's adolescents live, socioeconomic adversities affecting mental ill-health are prevalent, and mental health service resources remain very limited. Whilst digital delivery of Behavioural Activation presents a promising solution, its feasibility, acceptability, and effectiveness remain to be shown. Methods and analysis: This study is a two-arm single-blind individual-level randomised controlled pilot trial to assess the feasibility, acceptability, and initial efficacy of digitally delivered Behavioural Activation (BA) therapy amongst adolescents with depression. The intervention has been co-produced with adolescents at the study site. The study is based in the rural north-east of South Africa in the Bushbuckridge sub-district of Mpumalanga Province. A total of 200 adolescents with symptoms of mild to moderately-severe depression on the Patient Health Questionnaire Adolescent Version (PHQ-A) will be recruited (1:1 allocation ratio). The treatment group will receive digitally delivered Behavioural Activation (the Kuamsha app programme) whilst the control group will receive an Enhanced Standard of Care. The feasibility and acceptability of the intervention will be evaluated using a mixed-methods design, and signals of initial efficacy of the intervention in reducing symptoms of depression will be determined on an intention-to-treat basis. Secondary objectives are to pilot a range of cognitive, mental health, risky behaviour, and socioeconomic measures; and to collect descriptive data on the feasibility of trial procedures to inform the development of a further larger trial. Ethics and dissemination: This study has been approved by the University of the Witwatersrand Human Research Ethics Committee (MED20-05-011) and the Oxford Tropical Research Ethics Committee (OxTREC 34-20). Study findings will be published in scientific open access peer-reviewed journals, presented at scientific conferences, and communicated to participants, their caregivers, public sector officials, and other relevant stakeholders. Trial registration: This trial was registered on 19 November 2020 with the South African National Clinical Trials Registry (DOH-27-112020-5741) and the Pan African Clinical Trials Registry (PACTR202206574814636).