NCT06828276

Brief 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. Investigator hypothesizes that there will be a significant decrease in psychological symptoms after participants receive the intervention compared to a control group.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress63%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

January 22, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 12, 2025

Status Verified

October 1, 2025

Enrollment Period

1.8 years

First QC Date

January 22, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

RefugeeCognitive behavioral therapyPsychological problemsPersian speakingPsychological well-beingYouthMental problemsResilienceAsylum seeker

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention

Secondary Outcomes (7)

  • Psychological Outcome Profiles (PSYCHLOPS)

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

  • Insomnia Severity Index (ISI)

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

  • Prolonged Grief Disorder (PG-13)

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

  • Posttraumatic Stress Disorder Checklist (PCL-5)

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

  • The World Health Organization-Five Well-Being Index (WHO-5)

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

  • +2 more secondary outcomes

Study Arms (2)

Active group

EXPERIMENTAL

Tailored I-CBT for mild to moderate common mental health problems over a 10-weeks-period.

Behavioral: Culturally adapted i-CBT

Waiting-list

NO INTERVENTION

Control group

Interventions

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.

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, 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.

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, 113 64, Sweden

RECRUITING

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 DisordersPsychological TraumaSleep Initiation and Maintenance DisordersPsychological Well-BeingRumination Syndrome

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPersonal SatisfactionGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Study Officials

  • Gerhard Andersson, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shervin Shahnavaz, PhD

CONTACT

Anahita Geranmayeh, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Lecturer

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 14, 2025

Study Start

March 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 12, 2025

Record last verified: 2025-10

Locations