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Kulturellt anpassad I-CBT för Farsi/Dari-talande migranter (i-CBT)

2 november 2026 uppdaterad av: Shervin Shahnavaz, Karolinska Institutet

Kulturellt och språkanpassad I-CBT för vanliga psykiska hälsoproblem: En randomiserad kontrollerad studie med Farsi/Dari-talande migranter

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Participants who are included in the study will be allocated to the experimental group and the control group (waiting list). Participants will be invited to participate tailored i-CBT intervention over 10-weeks. Intervention covers common psychological issues. Participants will have access to support through a chatting function, during the interventional period. Intervention effects will be measured prior-treatment, post-treatment, and 6 months post-treatment.

Studietyp

Interventionell

Inskrivning (Faktisk)

93

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Sverige
      • Stockholm, Sverige, 113 64
        • Karolinska Institutet

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

15 år till 29 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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, 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.

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Active group

Tailored I-CBT for mild to moderate common mental health problems over a 10-weeks-period.
Beteende: Culturally adapted i-CBT

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.
Inget ingripande: Waiting-list

Control group

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hopkins Symptom Checklist-25 (HSCL-25)
Tidsram: Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Psychological Outcome Profiles (PSYCHLOPS)
Tidsram: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

Impact of problematic area on function. PSYCHLOPS questionnaire consists of 4 items. These items are designed to capture the patient's main problem, the impact of this problem on their daily life, and their overall well-being. Each question in PSYCHLOPS is scored on a scale from 0 to 5, where 0 indicates no problem and 5 indicates the most severe problem. Higher scores indicate a worse outcome, as they reflect greater severity of problems or distress.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Insomnia Severity Index (ISI)
Tidsram: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

Assessment of severity of insomnia symptoms. ISI consists of 7 items, each rated on a scale from 0 to 4.Higher scores indicate a worse outcome, as they reflect more severe insomnia symptoms.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Prolonged Grief Disorder (PG-13)
Tidsram: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

Assessment of prolonged grief disorder. The PG-13 consists of 13 items, each rated on a scale from 1 to 5, where 1 means "Not at all" and 5 means "Several times a day". Higher scores indicate a worse outcome, as they reflect more severe symptoms of prolonged grief.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Posttraumatic Stress Disorder Checklist (PCL-5)
Tidsram: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

Assessment of symptoms of post-traumatic stress disorder. The PCL-5 consists of 20 items, each rated on a scale from 0 to 4. The total score ranges from 0 to 80. Higher scores indicate a worse outcome, as they reflect greater severity of PTSD symptoms.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
The World Health Organization-Five Well-Being Index (WHO-5)
Tidsram: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

Assessment of subjective psychological well-being.The WHO-5 consists of 5 items, each rated on a scale from 0 to 5. Higher scores indicate a better outcome, as they reflect higher levels of well-being.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Brief Resilience Scale (BRS)
Tidsram: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention

Assessment of resilience.The BRS consists of 6 items, each rated on a scale from 1 to 5. Higher scores indicate a better outcome, as they reflect greater resilience.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Client Satisfaction Questionnaire (CSQ-3)
Tidsram: Immediately after the intervention, 6 months after completion of the intervention

Assessment of the levels of satisfaction of the participant with the intervention.CSQ-3 consists of 3 items. Each item is rated on a scale from 1 to 4. Higher scores indicate a better outcome, as they reflect greater satisfaction with the services received.
Immediately after the intervention, 6 months after completion of the intervention

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Karolinska Institutet

Samarbetspartners

Linkoeping University

Utredare

  • Huvudutredare: Gerhard Andersson, PhD, Linkoeping University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 mars 2025

Primärt slutförande (Faktisk)

30 mars 2026

Avslutad studie (Faktisk)

30 september 2026

Studieregistreringsdatum

Först inskickad

22 januari 2025

Först inskickad som uppfyllde QC-kriterierna

13 februari 2025

Första postat (Faktisk)

14 februari 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 oktober 2025

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KI-CNS-20250117

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