Sharing HaRT in New Expanses

NCT ID: NCT06237439

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2025-05-31

Brief Summary

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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:

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

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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

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Depressive Symptoms Trauma, Psychological Anxiety Generalized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Move with HaRT

Intervention Type BEHAVIORAL

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

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).

Group Type ACTIVE_COMPARATOR

Move with HaRT

Intervention Type BEHAVIORAL

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

Interventions

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Move with HaRT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Innovations for Poverty Action

OTHER

Sponsor Role collaborator

University of Alabama, Tuscaloosa

OTHER

Sponsor Role lead

Responsible Party

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Catherine Carlson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine E Carlson

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Innovations for Poverty Action, Uganda

Kampala, , Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Gloria E Ayesiga, MA

Role: CONTACT

+256759252676

Facility Contacts

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Gloria E Ayesiga, MA

Role: primary

+256759252676

Other Identifiers

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23-02-6355

Identifier Type: -

Identifier Source: org_study_id

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