Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06237439
Other study ID # 23-02-6355
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05702086 - Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT06100146 - Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls N/A
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Completed NCT05376397 - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT04403126 - To Increase Psychological Well-being by the Implementation of Forgiveness Education N/A
Recruiting NCT05078424 - Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong N/A
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Recruiting NCT04082052 - Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike N/A
Completed NCT04011540 - Digital Data in Mental Health Therapy N/A
Not yet recruiting NCT06413849 - Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers N/A
Not yet recruiting NCT03659591 - Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost N/A
Not yet recruiting NCT02133170 - "Mindfulness vs Psychoeducation in Bipolar Disorder" N/A
Completed NCT02314390 - Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial N/A
Completed NCT01628016 - The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms N/A