Sharing HaRT in New Expanses

Not Applicable

Recruiting

• Conditions: Depressive Symptoms; Trauma, Psychological; Anxiety Generalized
• Interventions: Behavioral: Move with HaRT

• Registration Number: NCT06237439
• Lead Sponsor: University of Alabama, Tuscaloosa

Brief 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.

Study Timeline

• Study Start: 2023-08-21
• Status Verified: 2024-01
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2025-02
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 302

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Services as Usual	Move with HaRT	Services as usual are ongoing activities provided by anti-trafficking agencies that include basic counseling, vocational training, games and entertainment (e.g., movies and social activities).
Move with HaRT	Move with HaRT	Move with HaRT is a 12-session, weekly, manualized mental health intervention led by trained paraprofessionals. It is delivered in groups of 8-12 individuals and includes breathwork, yoga poses, guided meditations, and discussions aligned with weekly themes. Group discussions include topics such as noticing how we feel in our bodies, recognizing and allowing all emotions, practicing self-acceptance, and developing deeper connections with others with whom we feel safe.

Primary Outcome Measures

Name	Time	Method
PTSD Checklist (PCL-5)	Past one month	Severity of post-traumatic stress symptoms
GAD-7	Past one month	Severity of generalized anxiety symptoms
Patient Health Questionnaire (PHQ-9)	Past two weeks	Severity of depressive symptoms

Secondary Outcome Measures

Name	Time	Method
Women's Health Initiative Insomnia Rating Scale (WHIIRS)	Past four weeks	Severity of insomnia symptoms
Brief Pain Inventory (Short Form)	24 hours	Severity of pain
Multidimensional Scale of Perceived Social Support (MSPSS)	Past three months	Degree of perceived social support

Trial Locations

Locations (1)

Innovations for Poverty Action, Uganda; 🇺🇬 Kampala, Uganda