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
Stephen Tollman,
Kathleen Kahn,
F Xavier Gómez-Olivé,
Crick Lund,
Alan Stein,
Heather A O'Mahen,
Eustasius Musenge,
Sarah-Jayne Blakemore,
Alastair van Heerden,
Tholene Sodi,
Bianca D Moffett,
Julia R Pozuelo,
Michelle Craske,
Kate Orkin,
Emma J Kilford,
Mahreen Mahmud,
Meghan Davis,
Zamakhanya Makhanya,
Tlangelani Baloyi,
Daniel Mahlangu,
Gabriele Chierchia,
Sophie L Fielmann,
Imraan Valodia
Affiliations
Stephen Tollman
Umeå Centre for Global Health Research, Division of Epidemiology and Global Health, Department of Public Health and Clinical Medicine, Umeå Universitet, Umea, Sweden
Kathleen Kahn
Umeå Centre for Global Health Research, Division of Epidemiology and Global Health, Department of Public Health and Clinical Medicine, Umeå Universitet, Umea, Sweden
F Xavier Gómez-Olivé
Medical Research Council/Wits Rural Health and Health Transitions Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Crick Lund
4 Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King`s College London, London, UK
Alan Stein
Department of Psychiatry, University of Oxford, Oxford, UK
Heather A O'Mahen
Mood Disorders Centre, Department of Psychology, University of Exeter, Exeter, Devon, UK
Eustasius Musenge
MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Sarah-Jayne Blakemore
MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Alastair van Heerden
Centre for Community Based Research, Human Sciences Research Council, Pietermaritzburg, South Africa
Tholene Sodi
SAMRC-DSI/NRF-UL SARChI Research Chair in Mental Health and Society, Faculty of Humanities, University of Limpopo, Polokwane, Limpopo, South Africa
Bianca D Moffett
MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Julia R Pozuelo
1 Department of Global Health and Social Medicine, Harvard University, Cambridge, Massachusetts, USA
Michelle Craske
Department of Psychology, University of California Los Angeles (UCLA), Los Angeles, California, USA
Kate Orkin
Blavatnik School of Government, University of Oxford, Oxford, UK
Emma J Kilford
Department of Clinical, Educational and Health Psychology, University College London, London, UK
Mahreen Mahmud
Department of Economics, University of Exeter, Exeter, UK
Meghan Davis
Department of Psychiatry, University of Oxford, Oxford, UK
Zamakhanya Makhanya
MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Tlangelani Baloyi
Department of Psychology, University of Limpopo, Polokwane, South Africa
Daniel Mahlangu
MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Gabriele Chierchia
Department of Psychology, University of Cambridge, Cambridge, UK
Sophie L Fielmann
Department of Psychology, University of Cambridge, Cambridge, UK
Imraan Valodia
Southern Centre for Inequality Studies, University of the Witwatersrand, Johannesburg, South Africa
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).
