Clinical trial NCT06102096: Culturally Adapted iCBT for Arabic-speaking Refugee and Migrant Youth With Common Mental Health Problems
Official title: A Randomized Controlled Trial of a Culturally Adapted iCBT for Arabic-speaking Refugee Youth With Common Mental Health Problems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Insomnia
Grief
Psychological Trauma
Resilience
Stress
Marital Relationship
Psychological Well-Being
Keywords: Cognitive behavioral therapy
Psychological well-being
Resilience
Refugee
migrant
youth
mental problems
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2023-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: HSCL-25
timeFrame: Pre-intervention, during the intervention, immediately after the intervention, 6 months after completion of the intervention
Secondary outcomes:
measure: PHQ-9
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: PSYCHLOPS
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: ISI
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: PG-13
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: PCL-5
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: WHO-5
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
measure: BRS
timeFrame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Other outcomes:
measure: CSQ
timeFrame: immediately after the intervention, 6 months after completion of the intervention
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.