Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants (i-CBT)

December 5, 2025 updated by: Shervin Shahnavaz, Karolinska Institutet

Culturally and Language-Adapted i-CBT for Common Mental Health Problems: A Randomized Controlled Study With 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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, 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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active group
Tailored I-CBT for mild to moderate common mental health problems over a 10-weeks-period.
Behavioral: Culturally adapted i-CBT
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.
No Intervention: Waiting-list
Control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
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.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
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.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
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.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
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.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
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.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
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.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linkoeping University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KI-CNS-20250117

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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