Sharing HaRT in New Expanses (SHiNE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Symptoms; Trauma, Psychological; Anxiety Generalized
• Intervention / Treatment: Behavioral: Move with HaRT

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 Type: Interventional
• Enrollment (Estimated): 302
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gloria E Ayesiga, MA; Phone Number: +256759252676; Email: gayesiga@poverty-action.org

Study Locations

• Uganda
  • Kampala, Uganda
    • Recruiting
    • Innovations for Poverty Action, Uganda
    • Contact: Gloria E Ayesiga, MA; Phone Number: +256759252676; Email: gayesiga@poverty-action.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Move with HaRT; Move with HaRT is a group-based, manualized mind-body intervention.
Active Comparator: Services as Usual; 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).	Behavioral: Move with HaRT; Move with HaRT is a group-based, manualized mind-body intervention.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama, Tuscaloosa
• Collaborators: Innovations for Poverty Action
• Investigators: Principal Investigator: Catherine E Carlson, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Depression; Psychological Trauma
• Other Study ID Numbers: 23-02-6355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No