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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Experimental | Tailored I-CBT for mild to moderate common mental health problems over a 10-weeks-period. |
|
| Waiting-list | No Intervention | Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally adapted i-CBT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shervin Shahnavaz, PhD | Contact | 0046722154769 | shervin.shahnavaz@ki.se | |
| Anahita Geranmayeh, MSc | Contact | 0046737121661 | Anahita.geranmayeh@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Gerhard Andersson, PhD | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Recruiting | Stockholm | 113 64 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37999955 | Background | 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. | |
| 35433279 |
| Label | URL |
|---|---|
| Description Registration page | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000067073 | Psychological Trauma |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000092862 | Psychological Well-Being |
| D000079562 | Rumination Syndrome |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
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No masking
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| 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. | 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. | 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. | 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. | 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. | 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. | Immediately after the intervention, 6 months after completion of the intervention |
| 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. |
| Description About the research project | View source |
| D000068099 |
| Trauma and Stressor Related Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010549 | Personal Satisfaction |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |