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临床试验/NCT06464627
NCT06464627已完成不适用

Physical Activity Reduces Anxiety and Depression in Youth Affected by Displacement: a Randomized Controlled Trial of the Game Connect Program in Uganda

KU Leuven1 个研究点 分布在 1 个国家目标入组 866 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
KU Leuven
入组人数
866
试验地点
1
主要终点
Generalized Anxiety Disorder -7

研究概览

简要总结

This randomized controlled trial investigated 12 weeks of physical activity or to 12 weeks in a waiting control condition in youth aged 15 to 24 years old affected by displacement.

详细描述

In 2020, the Olympic Refuge Foundation (ORF) initiated Game Connect, a sport-for-protection project in Uganda. The current study lasted from September 2022 to August 2023. The project was executed by a consortium led by non-governmental organizations including AVSI Foundation, Right to Play, Youth Sport Uganda, the Uganda Olympic Committee, and the United Nations High Commissioner for Refugees. Included districts were Kampala, Rwamwanja, Palabek, Adjumani, and Kyangwali as they host the largest refugee settlements. Also the surrounding host communities were included. A total of 1,912 potential villages that could be targeted were identified, some of which were grouped in clusters. The decision to cluster villages was influenced by factors such as the limited number of young people in some villages and proximity of households to each other despite living in different villages. In total, 869 villages out of the 1,912 were at random selected for inclusion in the program. Block randomization was applied to ensure equal representation across the targeted districts. Following selection of the villages, all youth in selected villages were identified. Eligible participants in the selected 869 villages of the five catchment areas were: (a) young displaced or host-community adolescents and young adults aged 15 to 24 years, and (b) at least mild symptoms of anxiety and/ or depression, defined as a Patient Health Questionnaire -9, adolescent version (PHQ-9-A) (Spitzer et al., 1999) and / or the Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) score of 5 or higher. Those with severe depression (PHQ-9-A≥20) and / or anxiety (GAD-7≥15) were eligible to participate, but additionally referred to local services for specialized support. Eligible young people were at random allocated to either 12 weeks of physical activity or to 12 weeks in a waiting control condition. All participants completed at baseline and immediately post-intervention the interviewer-administered PHQ-9-A (Spitzer et al., 1999) and GAD-7 (Spitzer et al., 2006). An independent team of well-trained research assistants performed the interviews to minimize potential bias. The research assistants were recruited locally from refugee settlements and surrounding host communities. Data collection tools were pretested to ensure coherence and understandability of questions before the actual data collection commenced. Ethical approval was obtained from the Makerere University School of Social Sciences Research Ethics Committee and the Uganda National Council for Science and Technology. Informed written assent was obtained from all participants. Consent was secured from the current caregivers of youths aged 15-17 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • a) young displaced or host-community adolescents and young adults aged 15 to 24 years, and (b) at least mild symptoms of anxiety and/ or depression, defined as a Patient Health Questionnaire -9, adolescent version (PHQ-9-A) (Spitzer et al., 1999) and / or the Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) score of 5 or higher

排除标准

  • a) young displaced or host-community adolescents and young adults younger than 15 and older than 24 years, and (b) no symptoms of anxiety and/ or depression, defined as a Patient Health Questionnaire -9, adolescent version (PHQ-9-A) (Spitzer et al., 1999) and / or the Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006) score lower than 5

结局指标

主要结局

Generalized Anxiety Disorder -7

时间窗: 2 weeks

Patient Health Questionnaire-9

时间窗: 2 weeks

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Davy Vancampfort

Professor

KU Leuven

研究点 (1)

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