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临床试验/NCT06237439
NCT06237439招募中不适用

Sharing HaRT in New Expanses: Evaluating the Move With HaRT Intervention on Improving Mental Health of Human Trafficking Survivors

University of Alabama, Tuscaloosa1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2023年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
302
试验地点
1
主要终点
PTSD Checklist (PCL-5)

研究概览

简要总结

The goal of this parallel cluster randomized control (CRT) trial is to evaluate a group-based mind-body intervention (Move with HaRT) in survivors of human trafficking. The main study aims are:

  1. Determine effectiveness of the Move with HaRT intervention on PTSD, depression, and anxiety symptoms among survivors of human trafficking in Uganda
  2. Explore participant characteristics (e.g., age, trafficking history, food security) that may moderate the intervention effectiveness.
  3. Understand potential barriers and facilitators to future implementation and scale-up.

Participants will complete:

  • Complete three surveys (baseline, endline, and 3 month follow-up)
  • Participate in either Services as Usual or Move with HaRT groups
  • Qualitative in-depth interviews

Researchers will compare Move with HaRT with Services as Usual to see effects on mental health symptoms.

详细描述

Despite significant mental health challenges experienced by human trafficking survivors, a lack of research on effective interventions exists. The proposed parallel cluster randomized control trial aims to evaluate the mental health impact of Move with HaRT with human trafficking survivors in Uganda. Move with HaRT is a group-based intervention facilitated by paraprofessionals that includes breathwork, yoga poses, meditation, and discussions. The proposed study will use a parallel cluster randomized control (CRT) trial with 302 survivors randomized in groups to either Move with HaRT or Services as Usual. The main study aims are: 1) Determine effectiveness of the Move with HaRT intervention on PTSD, depression, and anxiety symptoms among survivors of human trafficking in Uganda; 2) Explore participant characteristics (e.g., age, trafficking history, food security) that may moderate the intervention effectiveness; 3) Understand potential barriers and facilitators to future implementation and scale-up. Surveys at baseline, endline, and 3-month follow-up assess mental health outcomes, as well as secondary outcomes on physical and social wellbeing. Qualitative research will inform barriers and facilitators to future implementation and scale-up. Results of this study have the potential to inform protection services in Uganda and beyond.

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 (Outcomes Assessor)

盲法说明

Outcome assessors will not be informed of the arm of participants prior to conducting assessments.

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • identify as female;
  • history of forced labor or sex trafficking;
  • aged 14 and above;

排除标准

  • physically unable to perform basic day-to-day activities without assistance
  • does not provide consent (or assent if a minor)

结局指标

主要结局

PTSD Checklist (PCL-5)

时间窗: Past one month

Severity of post-traumatic stress symptoms

GAD-7

时间窗: Past one month

Severity of generalized anxiety symptoms

Patient Health Questionnaire (PHQ-9)

时间窗: Past two weeks

Severity of depressive symptoms

次要结局

  • Brief Pain Inventory (Short Form)(24 hours)
  • Multidimensional Scale of Perceived Social Support (MSPSS)(Past three months)
  • Women's Health Initiative Insomnia Rating Scale (WHIIRS)(Past four weeks)

研究者

发起方
University of Alabama, Tuscaloosa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Carlson

Associate Professor

University of Alabama, Tuscaloosa

研究点 (1)

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