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NCT Number: NCT06828276

Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants

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.

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Key information

Conditions

Depressive Symptoms Anxiety Disorders Anxiety Symptoms Behavior Behavioral Symptoms Common Mental Health Problems Depression Digestive System Diseases Dyssomnias Feeding and Eating Disorders Gastrointestinal Diseases Grief Insomnia Marital Relationship Mental Disorders Nervous System Diseases Personal Satisfaction Psychological Trauma Psychological Well Being Psychological Well-Being Resilience Rumination Rumination Syndrome Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wellbeing

Age range

15 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culturally adapted i-CBT

Behavioral

A culturally and language adapted i-CBT intervention for Farsi/Dari speaking youth migrants and refugees. The intervention targets mild to moderate common mental health problems.

Primary outcomes

  1. Hopkins Symptom Checklist-25 (HSCL-25)

    Time frame: 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 outcomes

  1. Psychological Outcome Profiles (PSYCHLOPS)

    Time frame: 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.

  2. Insomnia Severity Index (ISI)

    Time frame: 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.

  3. Prolonged Grief Disorder (PG-13)

    Time frame: 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.

  4. Posttraumatic Stress Disorder Checklist (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. 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.

  5. The World Health Organization-Five Well-Being Index (WHO-5)

    Time frame: 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.

  6. Brief Resilience Scale (BRS)

    Time frame: 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.

  7. Client Satisfaction Questionnaire (CSQ-3)

    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.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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anahita Geranmayeh, MSc

CONTACT

[email protected]

0046737121661

Shervin Shahnavaz, PhD

CONTACT

[email protected]

0046722154769

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

Culturally and Language-Adapted i-CBT for Common Mental Health Problems: A Randomized Controlled Study With Farsi/Dari-Speaking Migrants

Acronym: i-CBT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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