Sharing HaRT in New Expanses

NCT06237439 | Unknown

• 1 other identifier: 23-02-6355
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Depressive Symptoms; Trauma, Psychological; Anxiety Generalized

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Brief Pain Inventory (Short Form)

  24 hours

• Women's Health Initiative Insomnia Rating Scale (WHIIRS)

  Past four weeks

• Multidimensional Scale of Perceived Social Support (MSPSS)

  Past three months

Study Arms (2)

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.

Behavioral: Move with HaRT

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).

Behavioral: Move with HaRT

Interventions

Move with HaRT BEHAVIORAL

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

Move with HaRT; Services as Usual

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• Innovations for Poverty Action: collaborator

Study Sites (1)

Innovations for Poverty Action, Uganda

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Depression; Psychological Trauma; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Anxiety Disorders

Study Officials

• Catherine E Carlson

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria E Ayesiga, MA

CONTACT

+256759252676; gayesiga@poverty-action.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will not be informed of the arm of participants prior to conducting assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: August 21, 2023
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)