Clinical trial NCT06237439: Sharing HaRT in New Expanses
Official title: Sharing HaRT in New Expanses: Evaluating the Move With HaRT Intervention on Improving Mental Health of Human Trafficking Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Trauma, Psychological
Anxiety Generalized
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
First posted: 2024-02-01
Enrollment: 302
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Past two weeks
measure: PTSD Checklist (PCL-5)
timeFrame: Past one month
measure: GAD-7
timeFrame: Past one month
Secondary outcomes:
measure: Brief Pain Inventory (Short Form)
timeFrame: 24 hours
measure: Women's Health Initiative Insomnia Rating Scale (WHIIRS)
timeFrame: Past four weeks
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Past three months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Innovations for Poverty Action, Uganda
Study officials:
affiliation: University of Alabama at Birmingham
name: Catherine E Carlson
role: PRINCIPAL_INVESTIGATOR
References: