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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.

Published version
Peer-reviewed

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Authors

van Heerden, Alastair  ORCID logo  https://orcid.org/0000-0003-2530-6885
O'Mahen, Heather A 
Craske, Michelle 

Abstract

INTRODUCTION: Scalable psychological treatments to address depression among adolescents are urgently needed. This is particularly relevant to low-income and middle-income countries where 90% of the world's adolescents live. While digital delivery of behavioural activation (BA) presents a promising solution, its feasibility, acceptability and effectiveness among adolescents in an African context 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 BA therapy among adolescents with depression. The intervention has been coproduced with adolescents at the study site. The study is based in the rural northeast of South Africa in the Bushbuckridge subdistrict of Mpumalanga province. A total of 200 adolescents with symptoms of mild to moderately severe depression on the Patient Health Questionnaire Adolescent Version will be recruited (1:1 allocation ratio). The treatment group will receive BA therapy via a smartphone application (the Kuamsha app) supported by trained peer mentors. 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 the 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 NUMBERS: 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).

Description

Peer reviewed: True


Acknowledgements: We would like to acknowledge the field supervisors Meriam Meritze, Princess Makhubela and Nokthula Mayindi, as well as all the fieldworkers, registered counsellor, Tinyiko Mafumo and peer mentors for their hard work and dedication. We would also like to thank all the adolescents who were involved in the formative work and participatory workshops that were integral to the design and development of the intervention, as well as the educators, healthcare workers and non-governmental organisations that provided valuable input into the trial design, particularly regarding recruitment and risk management strategies.

Keywords

Child & adolescent psychiatry, Depression & mood disorders, PUBLIC HEALTH, Humans, Adolescent, Depression, South Africa, Pilot Projects, Single-Blind Method, Behavior Therapy, Randomized Controlled Trials as Topic

Journal Title

BMJ Open

Conference Name

Journal ISSN

2044-6055
2044-6055

Volume Title

Publisher

BMJ
Sponsorship
MRC (via Wits Health Consortium (Pty) Ltd) (MR/S008748/1)