Depressive SymptomsSHiNENCT06237439
Sharing HaRT in New Expanses
A study testing Move with HaRT in people with Depressive Symptoms and Trauma, Psychological, run by University of Alabama, Tuscaloosa at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Trauma, Psychological, Anxiety Generalized
- What is being tested?
- Move with HaRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteUganda
- Study dates
- 21 Aug 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- identify as female;
- history of forced labor or sex trafficking;
- aged 14 and above;
Who cannot join
- physically unable to perform basic day-to-day activities without assistance
- does not provide consent (or assent if a minor)
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Innovations for Poverty Action, Uganda
Kampala
Gloria E Ayesiga, MA, +256759252676, gayesiga@poverty-action.org
About this study
Official title: Sharing HaRT in New Expanses: Evaluating the Move With HaRT Intervention on Improving Mental Health of Human Trafficking Survivors
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:
- Determine effectiveness of the Move with HaRT intervention on PTSD, depression, and anxiety symptoms among survivors of human trafficking in Uganda
- Explore participant characteristics (e.g., age, trafficking history, food security) that may moderate the intervention effectiveness.
- Understand potential barriers and facilitators to future implementation and scale-up.
Read more
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.
Read the 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.
- Being tested
- Move with HaRT
- Medical subject headings
- Depression, Psychological Trauma, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Move with HaRTBehavioural
Move with HaRT is a group-based, manualized mind-body intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Move with HaRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
Severity of depressive symptoms
Measured: Past two weeks
PTSD Checklist (PCL-5)
Severity of post-traumatic stress symptoms
Measured: Past one month
GAD-7
Severity of generalized anxiety symptoms
Measured: Past one month
Secondary outcomes (3)
Brief Pain Inventory (Short Form)
Severity of pain
Measured: 24 hours
Women's Health Initiative Insomnia Rating Scale (WHIIRS)
Severity of insomnia symptoms
Measured: Past four weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
Degree of perceived social support
Measured: Past three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start21 Aug 2023
- Primary completionFeb 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- Innovations for Poverty Action
- Responsible party
- Principal investigator, Catherine Carlson, University of Alabama, Tuscaloosa
- Investigators
- Catherine E Carlson, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237439
- Sponsor's protocol ID
- 23-02-6355
- Acronym
- SHiNE
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sharing HaRT in New Expanses: Evaluating the Move With HaRT Intervention on Improving Mental Health of Human Trafficking Survivors
- ClinicalTrials.gov ID
- NCT06237439
- Acronym / sponsor ID
- SHiNE / 23-02-6355
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- Innovations for Poverty Action
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine effectiveness of the Move with HaRT intervention on PTSD, depression, and anxiety symptoms among survivors of human trafficking in Uganda
- Explore participant characteristics (e.g., age, trafficking history, food security) that may moderate the intervention effectiveness.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Move with HaRT | Experimental | Behavioral: Move with HaRTMove 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. |
| Services as Usual | Active comparator | Behavioral: Move with HaRTServices 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). |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- identify as female;
- history of forced labor or sex trafficking;
- aged 14 and above;
Key exclusion criteria (2 listed)
- physically unable to perform basic day-to-day activities without assistance
- does not provide consent (or assent if a minor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Move with HaRTMove with HaRT is a group-based, manualized mind-body intervention. | Behavioural | Move with HaRT, Services as Usual |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: Past two weeks
Severity of depressive symptoms
PTSD Checklist (PCL-5)
Time frame: Past one month
Severity of post-traumatic stress symptoms
GAD-7
Time frame: Past one month
Severity of generalized anxiety symptoms
3 secondary outcomes
Brief Pain Inventory (Short Form)
Time frame: 24 hours
Women's Health Initiative Insomnia Rating Scale (WHIIRS)
Time frame: Past four weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Past three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine E Carlson principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Move with HaRT in people with Depressive Symptoms and Trauma, Psychological, run by University of Alabama, Tuscaloosa at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gloria E Ayesiga, MA (+256759252676, gayesiga@poverty-action.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: Past two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.