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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06102096
Other study ID # KI-CNS-230918
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 27, 2023
Est. completion date September 30, 2025

Study information

Verified date February 2024
Source Karolinska Institutet
Contact Shervin Shahnavaz, PhD
Phone +46763238783
Email shervin.shahnavaz@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 15 Years to 29 Years
Eligibility 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, 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. 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


Intervention

Behavioral:
Culturally Adapted iCBT
A culturally adapted iCBT targeting mild to moderate mental health problems among Arabic-speaking refugee and migrant youth.

Locations

Country Name City State
Sweden Karolinska Institutet Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Linkoping University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View Citation

Lindegaard 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other CSQ assessment of the levels of satisfaction of the participant with the intervention immediately after the intervention, 6 months after completion of the intervention
Primary HSCL-25 Assessment of anxiety and depressive symptoms Pre-intervention, during the intervention, immediately after the intervention, 6 months after completion of the intervention
Secondary PHQ-9 assessment of depressive symptoms Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Secondary PSYCHLOPS Impact of problematic area on function Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Secondary ISI Assessment of severity of insomnia Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Secondary PG-13 Assessment of prolonged grief disorder Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Secondary PCL-5 assessment of symptoms of post-traumatic stress disorder Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Secondary WHO-5 assessment of subjective psychological well-being Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Secondary BRS assessment of resilience Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
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