An interventional study of Culturally adapted i-CBT in Depressive Symptoms, Anxiety Symptoms and Grief, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 15 Years to 29 Years. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 128 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tailored I-CBT for mild to moderate common mental health problems over a 10-weeks-period.
Behavioral: Culturally adapted i-CBT
Control group
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.
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.
Time frame: Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention
Psychological Outcome Profiles (PSYCHLOPS)
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.
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Insomnia Severity Index (ISI)
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.
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Prolonged Grief Disorder (PG-13)
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.
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Posttraumatic Stress Disorder Checklist (PCL-5)
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.
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
The World Health Organization-Five Well-Being Index (WHO-5)
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.
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Brief Resilience Scale (BRS)
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.
Time frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Client Satisfaction Questionnaire (CSQ-3)
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.
Time frame: Immediately after the intervention, 6 months after completion of the intervention
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