Depressive Symptomsi-CBTNCT06828276
Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants
A study testing Culturally adapted i-CBT in people with Depressive Symptoms and Anxiety Symptoms, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 29 years
- Conditions the study is for
- Depressive Symptoms, Anxiety Symptoms, Grief
- What is being tested?
- Culturally adapted i-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- 25 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, 113 64
Shervin Shahnavaz, PhD, +46763238783, shervin.shahnavaz@ki.se
shervin.shahnavaz@ki.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Depressive Symptoms, Anxiety Symptoms, Grief, Psychological Trauma, Insomnia, Resilience
- Being tested
- Culturally adapted i-CBT
- Keywords
- Refugee, Cognitive behavioral therapy, Psychological problems, Persian speaking, Psychological well-being, Youth, Mental problems, Resilience, Asylum seeker
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Trauma, Sleep Initiation and Maintenance Disorders, Psychological Well-Being, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted i-CBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Tailored I-CBT for mild to moderate common mental health problems over a 10-weeks-period. Receives: Behavioral: Culturally adapted i-CBT |
| Waiting-list | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Symptom Checklist-25 (HSCL-25)
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.
Measured: Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention
Secondary outcomes (7)
Psychological Outcome Profiles (PSYCHLOPS)
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.
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Insomnia Severity Index (ISI)
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.
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Prolonged Grief Disorder (PG-13)
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.
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Posttraumatic Stress Disorder Checklist (PCL-5)
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.
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
The World Health Organization-Five Well-Being Index (WHO-5)
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.
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Brief Resilience Scale (BRS)
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.
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Client Satisfaction Questionnaire (CSQ-3)
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.
Measured: Immediately after the intervention, 6 months after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start25 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Shervin Shahnavaz, Karolinska Institutet
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828276
- Sponsor's protocol ID
- KI-CNS-20250117
- Acronym
- i-CBT
- Status last verified
- Oct 2025
- First submitted
- 22 Jan 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37999955Lindegaard 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.
PubMed 35433279
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally and Language-Adapted i-CBT for Common Mental Health Problems: A Randomized Controlled Study With Farsi/Dari-Speaking Migrants
- ClinicalTrials.gov ID
- NCT06828276
- Acronym / sponsor ID
- i-CBT / KI-CNS-20250117
- Conditions
- Depressive Symptoms, Anxiety Symptoms, Grief, Psychological Trauma, Insomnia, Resilience
- Keywords
- Refugee, Cognitive behavioral therapy, Psychological problems, Persian speaking, Psychological well-being, Youth, Mental problems, Resilience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Behavioral: Culturally adapted i-CBTTailored I-CBT for mild to moderate common mental health problems over a 10-weeks-period. |
| Waiting-list | No intervention | –Control group |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally adapted i-CBTA 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. | Behavioural | Active group |
Primary outcome
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.
7 secondary outcomes
Psychological Outcome Profiles (PSYCHLOPS)
Time frame: 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
Prolonged Grief Disorder (PG-13)
Time frame: 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
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
Brief Resilience Scale (BRS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 37999955Demetry 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.
- Background: PubMed 35433279Lindegaard 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.
- Description Registration pageLink provided by the sponsor.
- Description About the research projectLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerhard Andersson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted i-CBT in people with Depressive Symptoms and Anxiety Symptoms, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shervin Shahnavaz, PhD (0046722154769, shervin.shahnavaz@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06828276, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.