Clinical trial NCT06828276: Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants
Official title: Culturally and Language-Adapted i-CBT for Common Mental Health Problems: A Randomized Controlled Study With Farsi/Dari-Speaking Migrants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Anxiety Symptoms
Grief
Psychological Trauma
Insomnia
Resilience
Stress
Psychological Well Being
Marital Relationship
Wellbeing
Common Mental Health Problems
Rumination
Keywords: Refugee
Cognitive behavioral therapy
Psychological problems
Persian speaking
Psychological well-being
Youth
Mental problems
Resilience
Asylum seeker
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2025-02-14
Enrollment: 128
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a culturally adapted internet-based cognitive behavioral therapy (i-CBT) intervention in reducing symptoms of common mental health issues among Farsi/Dari-speaking youth migrants and refugees. Investigator hypothesizes that there will be a significant decrease in psychological symptoms after participants receive the intervention compared to a control group.

Detailed description: Participants who are included in the study will be allocated to the experimental group and the control group (waiting list). Participants will be invited to participate tailored i-CBT intervention over 10-weeks. Intervention covers common psychological issues. Participants will have access to support through a chatting function, during the interventional period. Intervention effects will be measured prior-treatment, post-treatment, and 6 months post-treatment.

Eligibility criteria: 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, tablet or 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

Primary outcomes:
measure: Hopkins Symptom Checklist-25 (HSCL-25)
timeFrame: Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention
Secondary outcomes:
measure: Psychological Outcome Profiles (PSYCHLOPS)
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: Prolonged Grief Disorder (PG-13)
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: The World Health Organization-Five Well-Being Index (WHO-5)
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: Brief Resilience Scale (BRS)
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: Client Satisfaction Questionnaire (CSQ-3)
timeFrame: Immediately after the intervention, 6 months after completion of the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.