- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684810
Lay Therapist Effectiveness With Displaced Persons Kurdish Iraq
October 31, 2021 updated by: Meredith Blackwell, University of New Mexico
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erbil, Iraq
- Jiyan Foundation for Human Rights
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Must speak Arabic fluently; must be seeking mental health services at the Jiyan Foundation
Exclusion Criteria:
- No Arabic proficiency; under 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Treatment Group
Participants seeking treatment completed longitudinal data
|
Community Therapists Used CBT and EMDR Interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Symptoms
Time Frame: 3 months
|
Measured by the PCL-5
|
3 months
|
|
Depression Symptoms
Time Frame: 3 months
|
Measured by the PHQ-9
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
January 31, 2018
Study Completion (Actual)
January 31, 2018
Study Registration Dates
First Submitted
December 21, 2020
First Submitted That Met QC Criteria
December 21, 2020
First Posted (Actual)
December 28, 2020
Study Record Updates
Last Update Posted (Actual)
November 8, 2021
Last Update Submitted That Met QC Criteria
October 31, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Jiyan01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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)
IPD Sharing Time Frame
Data will be available for two years after reporting and by request following.
IPD Sharing Access Criteria
Data is publicly available at OSF for download, or can be requested by contacting blackwell@unm.edu
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.