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.
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.
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DOI：
10.1136/bmjopen-2022-065977
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发表时间：
2022-12-30
期刊：
影响因子：
2.9
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中科院分区：
文献类型：
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作者：
迫切需要可扩展的心理治疗来解决青少年的抑郁症。这对低收入和中等收入国家尤其重要，世界上90%的青少年生活在这些国家。虽然行为激活（BA）的数字化交付提供了一个有希望的解决方案，但其在非洲青少年中的可行性，可接受性和有效性仍有待证明。本研究是一项双组单盲个体水平随机对照先导试验，旨在评估数字化BA治疗青少年抑郁症的可行性、可接受性和初步疗效。该干预措施是与研究中心的青少年共同制作的。这项研究是基于在南非东北部的农村，在普马兰加省的Bushbuckridge分区。将招募200名青少年患者健康问卷青少年版上有轻度至中重度抑郁症状的青少年（1：1分配比例）。治疗组将通过智能手机应用程序（Kuamsha应用程序）接受BA治疗，并由经过培训的同伴导师提供支持。对照组将接受更高标准的护理。将使用混合方法设计评价干预的可行性和可接受性，并在意向治疗的基础上确定干预在减轻抑郁症状方面的初始疗效信号。次要目标是试验一系列认知，心理健康，危险行为和社会经济措施;并收集有关试验程序可行性的描述性数据，以告知进一步更大规模试验的发展。本研究已获得威特沃特斯兰德大学人类研究伦理委员会（MED 20 -05-011）和牛津热带研究伦理委员会（OxTREC 34-20）的批准。研究结果将发表在科学开放获取同行评审期刊上，在科学会议上介绍，并传达给参与者，他们的照顾者，公共部门官员和其他相关利益攸关方。该试验于2020年11月19日在南非国家临床试验注册中心（DOH-27-112020-5741）和泛非临床试验注册中心（PACTR 202206574814636）注册。
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. 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. 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. 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).
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影响因子：
2.9
作者：
Avery KN;Williamson PR;Gamble C;O'Connell Francischetto E;Metcalfe C;Davidson P;Williams H;Blazeby JM;members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research
通讯作者：
members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research
影响因子：
3.7
作者：
Fekadu A;Demissie M;Birhane R;Medhin G;Bitew T;Hailemariam M;Minaye A;Habtamu K;Milkias B;Petersen I;Patel V;Cleare AJ;Mayston R;Thornicroft G;Alem A;Hanlon C;Prince M
通讯作者：
Prince M
影响因子：
7.4
作者：
Connor, KM;Davidson, JRT
通讯作者：
Davidson, JRT
影响因子：
168.9
作者：
Kakuma, Ritsuko;Minas, Harry;Scheffler, Richard M.
通讯作者：
Scheffler, Richard M.
影响因子：
6.9
作者：
Erskine HE;Moffitt TE;Copeland WE;Costello EJ;Ferrari AJ;Patton G;Degenhardt L;Vos T;Whiteford HA;Scott JG
通讯作者：
Scott JG