Mental HealthNCT04684810
Lay Therapist Effectiveness With Displaced Persons Kurdish Iraq
An observational study of Mental Health and Therapeutics, run by University of New Mexico at 1 site in Iraq.
Trial summary
Negative mental health effects of war exposure and displacement are pervasive, but many displaced persons and refugees in low-and-middle income countries lack access to evidence-based treatments. Community lay-therapists are a promising solution for the global mental health field. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Therapeutics
- What is being tested?
- Community Lay Therapist-Administered EBT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteIraq
- Study dates
- 1 Oct 2017to 31 Jan 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were 18-years-or-older Arabic speakers displaced from their homes in either Central/Southern Iraq or Syria and now residing in Kurdish Iraq and seeking treatment for mental health difficulties.
Who may be able to join
- Must speak Arabic fluently; must be seeking mental health services at the Jiyan Foundation
Who cannot join
- No Arabic proficiency; under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lay Therapist Effectiveness With Displaced Persons Kurdish Iraq: Promising Exploratory Results for Global Mental Health Access
Negative mental health effects of war exposure and displacement are pervasive, but many displaced persons and refugees in low-and-middle income countries lack access to evidence-based treatments. Community lay-therapists are a promising solution for the global mental health field. However, in spite of results from randomized-control trials, no research to-date has examined the external validity of community-led lay-therapist effectiveness. In this exploratory study, longitudinal data at three time points were collected from 28 Arabic-speaking displaced persons (nineteen women and nine men, ages 18-57) seeking mental health services from the Jiyan Foundation: a non-profit founded and based in Kurdish Iraq. Lay therapists trained in evidence-based treatments upon being hired operated largely independently of supervision from foreign clinicians. Participants in weekly psychotherapy completed the Posttraumatic Stress Checklist (PCL-5) and the Psychological Health Questionnaire (PHQ-9) at baseline, one month, and three months, as well as a modified measure assessing traumatic exposure, purpose-in-life, and a modified Afghan Daily Stressors Scale at baseline to assess for moderators of change over time.
- Conditions
- Mental Health, Therapeutics
- Being tested
- Community Lay Therapist-Administered EBT
- Keywords
- evidence-based treatments, refugee, lay therapists, global mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Lay Therapist-Administered EBTBehavioural
Community Therapists Used CBT and EMDR Interventions
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Participants seeking treatment completed longitudinal data Receives: Behavioral: Community Lay Therapist-Administered EBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms
Measured by the PCL-5
Measured: 3 months
Depression Symptoms
Measured by the PHQ-9
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Oct 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meredith Blackwell, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684810
- Sponsor's protocol ID
- Jiyan01
- Status last verified
- Oct 2021
- First submitted
- 21 Dec 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataset is available with participant answers, but original forms are not to be shared as some personal information was written in notes (i.e. names)
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lay Therapist Effectiveness With Displaced Persons Kurdish Iraq: Promising Exploratory Results for Global Mental Health Access
- ClinicalTrials.gov ID
- NCT04684810
- Acronym / sponsor ID
- Jiyan01
- Conditions
- Mental Health, Therapeutics
- Keywords
- evidence-based treatments, refugee, lay therapists, global mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 28 Dec 2020 (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.
Negative mental health effects of war exposure and displacement are pervasive, but many displaced persons and refugees in low-and-middle income countries lack access to evidence-based treatments. Community lay-therapists are a promising solution for the global mental health field. However, in spite of results from randomized-control trials, no research to-date has examined the external validity of community-led lay-therapist effectiveness. In this exploratory study, longitudinal data at three time points were collected from 28 Arabic-speaking displaced persons (nineteen women and nine men, ages 18-57) seeking mental health services from the Jiyan Foundation: a non-profit founded and based in Kurdish Iraq. Lay therapists trained in evidence-based treatments upon being hired operated largely independently of supervision from foreign clinicians. Participants in weekly psychotherapy completed the Posttraumatic Stress Checklist (PCL-5) and the Psychological Health Questionnaire (PHQ-9) at baseline, one month, and three months, as well as a modified measure assessing traumatic exposure, purpose-in-life, and a modified Afghan Daily Stressors Scale at baseline to assess for moderators of change over time.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Behavioral: Community Lay Therapist-Administered EBTParticipants seeking treatment completed longitudinal data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were 18-years-or-older Arabic speakers displaced from their homes in either Central/Southern Iraq or Syria and now residing in Kurdish Iraq and seeking treatment for mental health difficulties.
Key inclusion criteria (1 listed)
- Must speak Arabic fluently; must be seeking mental health services at the Jiyan Foundation
Key exclusion criteria (1 listed)
- No Arabic proficiency; under 18 years
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 |
|---|---|---|
| Community Lay Therapist-Administered EBTCommunity Therapists Used CBT and EMDR Interventions | Behavioural | Treatment Group |
Primary outcome
PTSD Symptoms
Time frame: 3 months
Measured by the PCL-5
Depression Symptoms
Time frame: 3 months
Measured by the PHQ-9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: Yes. Dataset is available with participant answers, but original forms are not to be shared as some personal information was written in notes (i.e. names)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Therapeutics, run by University of New Mexico at 1 site in Iraq.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Nov 2021. 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 Iraq. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptoms (time frame: 3 months). The study lists 2 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 8 Nov 2021.