Logie Carmen H, Okumu Moses, Kortenaar Jean-Luc, Gittings Lesley, Khan Naimul, Hakiza Robert, Kibuuka Musoke Daniel, Nakitende Aidah, Katisi Brenda, Kyambadde Peter, Khan Torsum, Lester Richard, Mbuagbaw Lawrence
Factor-Inwentash Faculty of Social Work, University of Toronto, Toronto, ON, Canada.
Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada.
JMIR Res Protoc. 2022 Dec 8;11(12):e42342. doi: 10.2196/42342.
Although mental health challenges disproportionately affect people in humanitarian contexts, most refugee youth do not receive the mental health support needed. Uganda is the largest refugee-hosting nation in Africa, hosting over 1.58 million refugees in 2022, with more than 111,000 living in the city of Kampala. There is limited information about effective and feasible interventions to improve mental health outcomes and mental health literacy, and to reduce mental health stigma among urban refugee adolescents and youth in low- and middle-income countries (LMICs). Virtual reality (VR) is a promising approach to reduce stigma and improve mental health and coping, yet such interventions have not yet been tested in LMICs where most forcibly displaced people reside. Group Problem Management Plus (GPM+) is a scalable brief psychological transdiagnostic intervention for people experiencing a range of adversities, but has not been tested with adolescents and youth to date. Further, mobile health (mHealth) strategies have demonstrated promise in promoting mental health literacy.
The aim of this study is to evaluate the feasibility and effectiveness of two youth-tailored mental health interventions (VR alone and VR combined with GMP+) in comparison with the standard of care in improving mental health outcomes among refugee and displaced youth aged 16-24 years in Kampala, Uganda.
A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomized in a 1:1:1 design. Approximately 330 adolescents (110 per cluster) are enrolled and will be followed for approximately 16 weeks. Data will be collected at three time points: baseline enrollment, 8 weeks following enrollment, and 16 weeks after enrollment. Primary (depression) and secondary outcomes (mental health literacy, attitudes toward mental help-seeking, adaptive coping, mental health stigma, mental well-being, level of functioning) will be evaluated.
The study will be conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (#40965; May 12, 2021), Mildmay Uganda Research Ethics Committee (MUREC-2021-41; June 24, 2021), and Uganda National Council for Science & Technology (SS1021ES; January 1, 2022). A qualitative formative phase was conducted using focus groups and in-depth, semistructured key informant interviews to understand contextual factors influencing mental well-being among urban refugee and displaced youth. Qualitative findings will inform the VR intervention, SMS text check-in messages, and the adaptation of GPM+. Intervention development was conducted in collaboration with refugee youth peer navigators. The trial launched in June 2022 and the final follow-up survey will be conducted in November 2022.
This study will contribute to the knowledge of youth-tailored mental health intervention strategies for urban refugee and displaced youth living in informal settlements in LMIC contexts. Findings will be shared in peer-reviewed publications, conference presentations, and with community dissemination.
ClinicalTrials.gov NCT05187689; https://clinicaltrials.gov/ct2/show/NCT05187689.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42342.
尽管心理健康挑战对处于人道主义环境中的人们影响尤为严重，但大多数难民青年并未获得所需的心理健康支持。乌干达是非洲接纳难民最多的国家，2022年接纳了超过158万难民，其中超过11.1万人生活在坎帕拉市。关于改善中低收入国家城市难民青少年心理健康状况、提高心理健康素养以及减少心理健康污名化的有效可行干预措施的信息有限。虚拟现实（VR）是一种有望减少污名化、改善心理健康和应对能力的方法，但此类干预措施尚未在大多数被迫流离失所者居住的中低收入国家进行测试。团体问题管理强化版（GPM+）是一种可扩展的简短心理跨诊断干预措施，适用于经历各种逆境的人群，但迄今为止尚未在青少年中进行测试。此外，移动健康（mHealth）策略在促进心理健康素养方面已显示出前景。
本研究旨在评估两种针对青少年的心理健康干预措施（单独使用VR以及VR与GMP+相结合）与标准护理相比，在改善乌干达坎帕拉市16至24岁难民和流离失所青年心理健康状况方面的可行性和有效性。
将在五个非正式定居点实施一项三臂整群随机对照试验，这些定居点根据距离分为三个地点，并按1:1:1的设计进行随机分组。招募约330名青少年（每个整群110名），并对其进行约16周的随访。将在三个时间点收集数据：基线入组时、入组后8周以及入组后16周。将评估主要结局（抑郁）和次要结局（心理健康素养、对寻求心理帮助的态度、适应性应对、心理健康污名化、心理健康状况、功能水平）。
本研究将按照CONSORT（试验报告统一标准）指南进行。该研究已获得多伦多大学（#40965；2021年5月12日）、乌干达米尔德梅研究伦理委员会（MUREC - 2021 - 41；2021年6月24日）以及乌干达国家科学技术委员会（SS1021ES；2022年1月1日）的伦理批准。使用焦点小组和深入的半结构化关键信息提供者访谈进行了定性形成阶段研究，以了解影响城市难民和流离失所青年心理健康的背景因素。定性研究结果将为VR干预、短信签到信息以及GPM+的调整提供参考。干预措施的开发是与难民青年同伴导航员合作进行的。该试验于2022年6月启动，最终随访调查将于2022年11月进行。
本研究将有助于了解针对生活在中低收入国家城市非正式定居点的难民和流离失所青年的青少年心理健康干预策略。研究结果将在同行评审的出版物、会议报告以及社区传播中分享。
ClinicalTrials.gov NCT05187689；https://clinicaltrials.gov/ct2/show/NCT051876S9。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/42342。
