- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06102096
Culturally Adapted iCBT for Arabic-speaking Refugee and Migrant Youth With Common Mental Health Problems (RAHA)
December 5, 2025 updated by: Shervin Shahnavaz, Karolinska Institutet
A Randomized Controlled Trial of a Culturally Adapted iCBT for Arabic-speaking Refugee Youth With Common Mental Health Problems
The aim of the current study is to explore whether culturally adapted internet-based cognitive behavioral therapy is effective in reducing the symptoms of various common mental health problems among Arabic-speaking refugee and migrant youth.
We hypothesize that the symptoms of the psychological problems will significantly be reduced among youth who will receive iCBT compared to youth in the control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Not Applicable
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
-
-
-
Stockholm, Sweden
- Karolinska Institutet
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Between the ages of 15 and 29.
- A score above the cut-off 1.75 on HSCL-25
- Has a refugee or migrant background
- Has a good and stable internet connection
- Has access to a computer, a tablet or a smartphone
- Is fluent in reading and writing Arabic
- Has the ability to dedicate time to take part in the intervention for 6-10 weeks.
Exclusion Criteria:
- Is suffering from a severe mental illness, such as psychosis or severe depression.
- Is suffering from substance abuse
- Is undergoing a psychological treatment
- Has a high risk of suicide
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active group
Tailored iCBT for mild to moderate common mental health problems over a period ranging from 6 to 10 weeks.
|
A culturally adapted iCBT targeting mild to moderate mental health problems among Arabic-speaking refugee and migrant youth.
|
|
No Intervention: Waiting-list
control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HSCL-25
Time Frame: Pre-intervention, during the intervention, immediately after the intervention, 6 months after completion of the intervention
|
Assessment of anxiety and depressive symptoms
|
Pre-intervention, during the intervention, immediately after the intervention, 6 months after completion of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PHQ-9
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
assessment of depressive symptoms
|
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
PSYCHLOPS
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Impact of problematic area on function
|
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
ISI
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Assessment of severity of insomnia
|
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
PG-13
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Assessment of prolonged grief disorder
|
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
PCL-5
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
assessment of symptoms of post-traumatic stress disorder
|
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
WHO-5
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
assessment of subjective psychological well-being
|
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
|
BRS
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
assessment of resilience
|
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CSQ
Time Frame: immediately after the intervention, 6 months after completion of the intervention
|
assessment of the levels of satisfaction of the participant with the intervention
|
immediately after the intervention, 6 months after completion of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gerhard Andersson, PhD, Linkoeping University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lindegaard T, Wasteson E, Demetry Y, Andersson G, Richards D, Shahnavaz S. Investigating the potential of a novel internet-based cognitive behavioural intervention for Dari and Farsi speaking refugee youth: A feasibility study. Internet Interv. 2022 Apr 1;28:100533. doi: 10.1016/j.invent.2022.100533. eCollection 2022 Apr.
- Demetry Y, Wasteson E, Lindegaard T, Abuleil A, Geranmayeh A, Andersson G, Shahnavaz S. Individually Tailored and Culturally Adapted Internet-Based Cognitive Behavioral Therapy for Arabic-Speaking Youths With Mental Health Problems in Sweden: Qualitative Feasibility Study. JMIR Form Res. 2023 Nov 24;7:e46253. doi: 10.2196/46253.
Helpful Links
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)
November 27, 2023
Primary Completion (Actual)
August 31, 2025
Study Completion (Actual)
August 31, 2025
Study Registration Dates
First Submitted
October 11, 2023
First Submitted That Met QC Criteria
October 20, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Actual)
December 12, 2025
Last Update Submitted That Met QC Criteria
December 5, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Stress Disorders, Traumatic
- Behavior
- Personal Satisfaction
- Psychological Trauma
- Anxiety Disorders
- Depression
- Sleep Initiation and Maintenance Disorders
- Psychological Well-Being
Other Study ID Numbers
- KI-CNS-230918
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.
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