Sharing HaRT in New Expanses

Depressive Symptoms Clinical Trial

— SHiNE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237439
• Other study ID #: 23-02-6355
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: University of Alabama, Tuscaloosa
• Contact: Gloria E Ayesiga, MA
• Phone: +256759252676
• Email: gayesiga[@]poverty-action.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: May 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Generalized
• Depression
• Depressive Symptoms
• Psychological Trauma
• Trauma, Psychological

Intervention

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

Locations

Country	Name	City	State
Uganda	Innovations for Poverty Action, Uganda	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	Innovations for Poverty Action

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire (PHQ-9)	Severity of depressive symptoms	Past two weeks
Primary	PTSD Checklist (PCL-5)	Severity of post-traumatic stress symptoms	Past one month
Primary	GAD-7	Severity of generalized anxiety symptoms	Past one month
Secondary	Brief Pain Inventory (Short Form)	Severity of pain	24 hours
Secondary	Women's Health Initiative Insomnia Rating Scale (WHIIRS)	Severity of insomnia symptoms	Past four weeks
Secondary	Multidimensional Scale of Perceived Social Support (MSPSS)	Degree of perceived social support	Past three months