NCT04684810

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

December 21, 2020

Last Update Submit

October 31, 2021

Conditions

Keywords

evidence-based treatmentsrefugeelay therapistsglobal mental health

Outcome Measures

Primary Outcomes (2)

  • PTSD Symptoms

    Measured by the PCL-5

    3 months

  • Depression Symptoms

    Measured by the PHQ-9

    3 months

Study Arms (1)

Treatment Group

Participants seeking treatment completed longitudinal data

Behavioral: Community Lay Therapist-Administered EBT

Interventions

Community Therapists Used CBT and EMDR Interventions

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Must speak Arabic fluently; must be seeking mental health services at the Jiyan Foundation

You may not qualify if:

  • No Arabic proficiency; under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiyan Foundation for Human Rights

Erbil, Iraq

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 28, 2020

Study Start

October 1, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

November 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be available for two years after reporting and by request following.
Access Criteria
Data is publicly available at OSF for download, or can be requested by contacting blackwell@unm.edu

Locations