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
Authors: Moffett Bianca D. , Pozuelo Julia R. , van Heerden Alastair , O’Mahen Heather A. , Craske Michelle , Sodi Tholene , Lund Crick , Orkin Kate , Kilford Emma J , Blakemore Sarah-Jayne , Mahmud Mahreen , Musenge Eustasius , Davis Meghan , Makhanya Zamakhanya , Baloyi Tlangelani , Mahlangu Daniel , Chierchia Gabriele , Fielmann Sophie L. , Gomez-Olive Xavier , Valodia Imraan , Tollman Stephen , Kahn Kathleen , Stein Alan 
Published: July 2022

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).

STRENGTHS AND LIMITATIONS

This study will address a critical evidence gap on managing adolescent depression in a low-resource African context by determining the feasibility, acceptability, and initial efficacy of digitally delivered Behavioural Activation therapy.

The intervention has been iteratively co-produced with local adolescents, clinicians and service/policy leads to ensure acceptability, cultural relevance, useability, and face validity of the intervention with the targeted population.

Novel culturally adapted measures of executive function and social cognition, as well as a range of relevant mental health, risky behaviours, and socioeconomic measures will be piloted.

This study is situated in a rural, socioeconomically disadvantaged area of South Africa, a middle-income country. Important contextual differences should be considered when evaluating the implications for other low- and middle-income countries and African populations.