Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants

Not Applicable

Not yet recruiting

• Conditions: Depressive Symptoms; Anxiety Symptoms; Grief; Psychological Trauma; Insomnia; Resilience; Stress; Psychological Well Being; Marital Relationship; Wellbeing

• Registration Number: NCT06828276
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study First Submitted: 2025-01-22
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Study Start: 2025-02-17
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hopkins Symptom Checklist-25 (HSCL-25)	Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention	Assessment of anxiety and depressive symptoms. HSCL-25 consists of 25 items.Each item is rated on a scale from 1 to 4, where 1 means "Not at all" and 4 means "Extremely".Higher scores indicate a worse outcome, as they reflect greater severity of symptoms.

Secondary Outcome Measures

Name	Time	Method
Psychological Outcome Profiles (PSYCHLOPS)	Pre-intervention, immediately after the intervention, 6 months after completion of the intervention	Impact of problematic area on function. PSYCHLOPS questionnaire consists of 4 items. These items are designed to capture the patient's main problem, the impact of this problem on their daily life, and their overall well-being. Each question in PSYCHLOPS is scored on a scale from 0 to 5, where 0 indicates no problem and 5 indicates the most severe problem. Higher scores indicate a worse outcome, as they reflect greater severity of problems or distress.
Insomnia Severity Index (ISI)	Pre-intervention, immediately after the intervention, 6 months after completion of the intervention	Assessment of severity of insomnia symptoms. ISI consists of 7 items, each rated on a scale from 0 to 4.Higher scores indicate a worse outcome, as they reflect more severe insomnia symptoms.
Prolonged Grief Disorder (PG-13)	Pre-intervention, immediately after the intervention, 6 months after completion of the intervention	Assessment of prolonged grief disorder. The PG-13 consists of 13 items, each rated on a scale from 1 to 5, where 1 means "Not at all" and 5 means "Several times a day". Higher scores indicate a worse outcome, as they reflect more severe symptoms of prolonged grief.
Posttraumatic Stress Disorder Checklist (PCL-5)	Pre-intervention, immediately after the intervention, 6 months after completion of the intervention	Assessment of symptoms of post-traumatic stress disorder. The PCL-5 consists of 20 items, each rated on a scale from 0 to 4. The total score ranges from 0 to 80. Higher scores indicate a worse outcome, as they reflect greater severity of PTSD symptoms.
The World Health Organization-Five Well-Being Index (WHO-5)	Pre-intervention, immediately after the intervention, 6 months after completion of the intervention	Assessment of subjective psychological well-being.The WHO-5 consists of 5 items, each rated on a scale from 0 to 5. Higher scores indicate a better outcome, as they reflect higher levels of well-being.
Brief Resilience Scale (BRS)	Pre-intervention, immediately after the intervention, 6 months after completion of the intervention	Assessment of resilience.The BRS consists of 6 items, each rated on a scale from 1 to 5. Higher scores indicate a better outcome, as they reflect greater resilience.
Client Satisfaction Questionnaire (CSQ-3)	Immediately after the intervention, 6 months after completion of the intervention	Assessment of the levels of satisfaction of the participant with the intervention.CSQ-3 consists of 3 items. Each item is rated on a scale from 1 to 4. Higher scores indicate a better outcome, as they reflect greater satisfaction with the services received.