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| Name | Class |
|---|---|
| Innovations for Poverty Action | OTHER |
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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:
Participants will complete:
Researchers will compare Move with HaRT with Services as Usual to see effects on mental health symptoms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Move with HaRT | Experimental | 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. |
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| Services as Usual | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Move with HaRT | Behavioral | Move with HaRT is a group-based, manualized mind-body intervention. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gloria E Ayesiga, MA | Contact | +256759252676 | gayesiga@poverty-action.org |
| Name | Affiliation | Role |
|---|---|---|
| Catherine E Carlson | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovations for Poverty Action, Uganda | Recruiting | Kampala | Uganda |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000067073 | Psychological Trauma |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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Outcome assessors will not be informed of the arm of participants prior to conducting assessments.
| Past four weeks |
| Multidimensional Scale of Perceived Social Support (MSPSS) | Degree of perceived social support | Past three months |
| D001523 | Mental Disorders |
| D001008 | Anxiety Disorders |