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

IntroductionScalable 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 analysisThis 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 disseminationThis 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 numbersThis 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).

Feasibility and utility of mobile health interventions for depression and anxiety in rural populations: A scoping review

“…Nine present data for feasibility, acceptability, or outcomes from the evaluation of mHealth interventions ( Bauer et al, 2017 ; Bhatia et al, 2021 ; Bhuiyan et al, 2021 ; Knutson et al, 2021 ; Maharjan et al, 2021 ; Seshu et al, 2021 ; Silfee et al, 2021 ; Vigil-Hayes et al, 2021 ; Forman-Hoffman et al, 2023 ) and two are study protocols describing development, deployment, or evaluation of future mHealth interventions ( Arenas-Castañeda et al, 2020 ; Moffett et al, 2022 ). Of these eleven studies, six were conducted in the U.S. ( Bauer et al, 2017 ; Bhuiyan et al, 2021 ; Knutson et al, 2021 ; Silfee et al, 2021 ; Vigil-Hayes et al, 2021 ; Forman-Hoffman et al, 2023 ) while the others were conducted in Mexico ( Arenas-Castañeda et al, 2020 ), Canada ( Bhatia et al, 2021 ), Nepal ( Maharjan et al, 2021 ), South Africa ( Moffett et al, 2022 ), and India ( Seshu et al, 2021 ). All included user depression and anxiety symptoms among the problems they were designed to address.…”

“… - In the future, StandStrong should be integrated with a self-report intervention, such as the Health Activity Program (HAP). Moffett et al, 2022 South Africa Protocol to evaluate feasibility, acceptability, and initial efficacy of the Kuamsha mobile app for adolescents in rural South Africa. - Kuamsha is an interactive narrative game with six tailored modules based on Behavioral Activation principles, coproduced with users.…”

“…Nine mHealth interventions are designed to provide psychoeducation and support: (SPIRIT) ( Bauer et al, 2017 ), Manage My Pain ( Bhatia et al, 2021 ), Calm ( Bhuiyan et al, 2021 ), WB-LIFE ( Forman-Hoffman et al, 2023 ), TExT ( Knutson et al, 2021 ), Kuamsha ( Moffett et al, 2022 ), IVRS ( Seshu et al, 2021 ), RxWell ( Silfee et al, 2021 ), and ARORA ( Vigil-Hayes et al, 2021 ). Kuamsha ( Moffett et al, 2022 ) is under development and will employ an interactive narrative game to engage and support adolescents with depressive symptoms living in rural South Africa. One app (StandStrong ( Maharjan et al, 2021 )) is designed for passive data collection with young mothers experiencing postpartum depression.…”

“…However, it is notable that three of the studies included in this review are based on interventions that were co-produced with rural users and/or providers ( Bauer et al, 2017 ; Vigil-Hayes et al, 2021 ; Moffett et al, 2022 ). Coproduction involves an iterative process of evidence review, systematic community input, intentional stakeholder and research team discussions, and intervention testing and refinement ( Hawkins et al, 2017 ).…”

“…Based upon insights gained through a coproduction development process, Bauer et al's ( Bauer et al, 2017 ) SPIRIT app includes a simplified installation and SMS-driven self-registration process, intentional complementarity to existing patient management systems within resource-limited rural settings (i.e., as opposed to stand-alone apps), and mechanisms for ongoing in-app feedback. Similarly, Moffett et al ( Moffett et al, 2022 ) gamified their Kuamsha app to be appealing to adolescent users with depression and included features such as character personification and the ability to earn in-app points. Vigil-Hayes et al ( Vigil-Hayes et al, 2021 ) went to great lengths to use coproduction methods to ensure that their ARORA app honored the rural Hopi and Navajo cultures for which it was designed.…”