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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
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06237439
Acronym
SHiNE
Enrollment
302
Registered
2024-02-01
Start date
2023-08-21
Completion date
2025-05-31
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Generalized, Depressive Symptoms, Trauma, Psychological

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.

Interventions

BEHAVIORALMove with HaRT

Move with HaRT is a group-based, manualized mind-body intervention.

Sponsors

Innovations for Poverty Action
CollaboratorOTHER
University of Alabama, Tuscaloosa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)Past two weeksSeverity of depressive symptoms
PTSD Checklist (PCL-5)Past one monthSeverity of post-traumatic stress symptoms
GAD-7Past one monthSeverity of generalized anxiety symptoms

Secondary

MeasureTime frameDescription
Brief Pain Inventory (Short Form)24 hoursSeverity of pain
Women's Health Initiative Insomnia Rating Scale (WHIIRS)Past four weeksSeverity of insomnia symptoms
Multidimensional Scale of Perceived Social Support (MSPSS)Past three monthsDegree of perceived social support

Countries

Uganda

Contacts

Primary ContactGloria E Ayesiga, MA
gayesiga@poverty-action.org+256759252676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026