Depressive SymptomsRAHANCT06102096
Culturally Adapted iCBT for Arabic-speaking Refugee and Migrant Youth With Common Mental Health Problems
A study testing Culturally Adapted iCBT in people with Depressive Symptoms and Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of the current study is to explore whether culturally adapted internet-based cognitive behavioral therapy is effective in reducing the symptoms of various common mental health problems among Arabic-speaking refugee and migrant youth. Read more about this study
- Who is it for?
- Ages 15 to 29 years
- Conditions the study is for
- Depressive Symptoms, Anxiety, Insomnia
- What is being tested?
- Culturally Adapted iCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSweden
- Study dates
- 27 Nov 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, a tablet or a 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.
About this study
Official title: A Randomized Controlled Trial of a Culturally Adapted iCBT for Arabic-speaking Refugee Youth With Common Mental Health Problems
The aim of the current study is to explore whether culturally adapted internet-based cognitive behavioral therapy is effective in reducing the symptoms of various common mental health problems among Arabic-speaking refugee and migrant youth. We hypothesize that the symptoms of the psychological problems will significantly be reduced among youth who will receive iCBT compared to youth in the control group.
- Conditions
- Depressive Symptoms, Anxiety, Insomnia, Grief, Psychological Trauma, Resilience
- Being tested
- Culturally Adapted iCBT
- Keywords
- Cognitive behavioral therapy, Psychological well-being, Resilience, Refugee, migrant, youth, mental problems
- Medical subject headings
- Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Psychological Trauma, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted iCBTBehavioural
A culturally adapted iCBT targeting mild to moderate mental health problems among Arabic-speaking refugee and migrant youth.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Tailored iCBT for mild to moderate common mental health problems over a period ranging from 6 to 10 weeks. Receives: Behavioral: Culturally Adapted iCBT |
| Waiting-list | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSCL-25
Assessment of anxiety and depressive symptoms
Measured: Pre-intervention, during the intervention, immediately after the intervention, 6 months after completion of the intervention
Secondary outcomes (7)
PHQ-9
assessment of depressive symptoms
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
PSYCHLOPS
Impact of problematic area on function
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
ISI
Assessment of severity of insomnia
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
PG-13
Assessment of prolonged grief disorder
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
PCL-5
assessment of symptoms of post-traumatic stress disorder
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
WHO-5
assessment of subjective psychological well-being
Measured: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
BRS
assessment of resilience
Measured: Pre-intervention, 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 posted26 Oct 2023
- Study start27 Nov 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
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
- 125 participants (actual)
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
- NCT06102096
- Sponsor's protocol ID
- KI-CNS-230918
- Acronym
- RAHA
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2023
- 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
- A Randomized Controlled Trial of a Culturally Adapted iCBT for Arabic-speaking Refugee Youth With Common Mental Health Problems
- ClinicalTrials.gov ID
- NCT06102096
- Acronym / sponsor ID
- RAHA / KI-CNS-230918
- Conditions
- Depressive Symptoms, Anxiety, Insomnia, Grief, Psychological Trauma, Resilience
- Keywords
- Cognitive behavioral therapy, Psychological well-being, Resilience, Refugee, migrant, youth, mental problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 26 Oct 2023 (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 the current study is to explore whether culturally adapted internet-based cognitive behavioral therapy is effective in reducing the symptoms of various common mental health problems among Arabic-speaking refugee and migrant youth. We hypothesize that the symptoms of the psychological problems will significantly be reduced among youth who will receive iCBT compared to youth in the control group.
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 iCBTTailored iCBT for mild to moderate common mental health problems over a period ranging from 6 to 10 weeks. |
| 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, a tablet or a 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 iCBTA culturally adapted iCBT targeting mild to moderate mental health problems among Arabic-speaking refugee and migrant youth. | Behavioural | Active group |
Primary outcome
HSCL-25
Time frame: Pre-intervention, during the intervention, immediately after the intervention, 6 months after completion of the intervention
Assessment of anxiety and depressive symptoms
7 secondary outcomes
PHQ-9
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
PSYCHLOPS
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
ISI
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
PG-13
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
PCL-5
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
WHO-5
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
BRS
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
- Registration pageLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
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 iCBT in people with Depressive Symptoms and Anxiety, 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HSCL-25 (time frame: Pre-intervention, during the intervention, 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 NCT06102096, 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.