NCT06102096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 27, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

December 12, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

October 11, 2023

Last Update Submit

December 5, 2025

Conditions

AnxietyInsomniaGriefPsychological TraumaResilienceStressMarital RelationshipPsychological Well-BeingDepressive Symptoms

Keywords

Cognitive behavioral therapyPsychological well-beingResilienceRefugeemigrantyouthmental problems

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • PHQ-9

    Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

  • PSYCHLOPS

    Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

  • ISI

    Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

  • PG-13

    Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

  • PCL-5

    Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

  • +2 more secondary outcomes

Other Outcomes (1)

  • CSQ

    immediately after the intervention, 6 months after completion of the intervention

Study Arms (2)

Active group

EXPERIMENTAL

Tailored iCBT for mild to moderate common mental health problems over a period ranging from 6 to 10 weeks.

Behavioral: Culturally Adapted iCBT

Waiting-list

NO INTERVENTION

control group

Interventions

Culturally Adapted iCBTBEHAVIORAL

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

Active group

Eligibility Criteria

Age15 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related 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.

    PMID: 37999955BACKGROUND

  • 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.

    PMID: 35433279BACKGROUND

Related Links

MeSH Terms

Conditions

DepressionAnxiety DisordersSleep Initiation and Maintenance DisordersPsychological TraumaPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersPersonal Satisfaction

Study Officials

  • Gerhard Andersson, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Lecturer

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 26, 2023

Study Start

November 27, 2023

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

December 12, 2025

Record last verified: 2025-01

Locations

SE(1)