RAHA: Culturally Adapted iCBT for Arabic-speaking Refugee and Migrant Youth With Common Mental Health Problems

Sponsor
Karolinska Institutet (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06102096
Collaborator
Linkoping University (Other)
120
2
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Culturally Adapted iCBT
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of a Culturally Adapted iCBT for Arabic-speaking Refugee Youth With Common Mental Health Problems
Anticipated Study Start Date :
Nov 6, 2023
Anticipated Primary Completion Date :
Jan 12, 2024
Anticipated Study Completion Date :
Jul 5, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active group

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

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

No Intervention: Waiting-list

control group

Outcome Measures

Primary Outcome Measures

  1. HSCL-25 [Pre-intervention, during the intervention, immediately after the intervention, 6 months after completion of the intervention]

    Assessment of anxiety and depressive symptoms

Secondary Outcome Measures

  1. PHQ-9 [Pre-intervention, immediately after the intervention, 6 months after completion of the intervention]

    assessment of depressive symptoms

  2. PSYCHLOPS [Pre-intervention, immediately after the intervention, 6 months after completion of the intervention]

    Impact of problematic area on function

  3. ISI [Pre-intervention, immediately after the intervention, 6 months after completion of the intervention]

    Assessment of severity of insomnia

  4. PG-13 [Pre-intervention, immediately after the intervention, 6 months after completion of the intervention]

    Assessment of prolonged grief disorder

  5. PCL-5 [Pre-intervention, immediately after the intervention, 6 months after completion of the intervention]

    assessment of symptoms of post-traumatic stress disorder

  6. WHO-5 [Pre-intervention, immediately after the intervention, 6 months after completion of the intervention]

    assessment of subjective psychological well-being

  7. BRS [Pre-intervention, immediately after the intervention, 6 months after completion of the intervention]

    assessment of resilience

Other Outcome Measures

  1. CSQ [immediately after the intervention, 6 months after completion of the intervention]

    assessment of the levels of satisfaction of the participant with the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Karolinska Institutet
  • Linkoping University

Investigators

  • Principal Investigator: Gerhard Andersson, PhD, Linkoping University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Shervin Shahnavaz, PhD Lecturer, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT06102096
Other Study ID Numbers:
  • KI-CNS-230918
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shervin Shahnavaz, PhD Lecturer, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2023