Clinical Trials Directory

Trials / Unknown

UnknownNCT06237439

Sharing HaRT in New Expanses

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
302 (estimated)
Sponsor
University of Alabama, Tuscaloosa · Academic / Other
Sex
Female
Age
14 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMove with HaRTMove with HaRT is a group-based, manualized mind-body intervention.

Timeline

Start date
2023-08-21
Primary completion
2025-02-01
Completion
2025-05-01
First posted
2024-02-01
Last updated
2024-02-01

Locations

1 site across 1 country: Uganda

Source: ClinicalTrials.gov record NCT06237439. Inclusion in this directory is not an endorsement.