Depression Clinical Trial
Official title:
Scaling-up Psychological Interventions With Syrian Refugees in Switzerland: RCT
Verified date | May 2023 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The current refugee crisis across the Middle East and Europe has large effects on individual refugees' psychological well-being, as well as on the healthcare systems of countries hosting refugees. For example, in Switzerland patients sometimes have to wait up to 12 months for the specific psychological treatment due to a lack of specialists. To address this problem the WHO has developed Problem Management Plus (PM+), a brief (five sessions), low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people in communities affected by adversity. The effectiveness and implementation of PM+ has never been examined in Switzerland before, this is the aim of the current randomized controlled trial.
Status | Completed |
Enrollment | 54 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male and female Arabic-speaking refugees or asylum seekers who entered Switzerland after March 2011 - = 18 years of age - Arabic-speaking (Levantine Arabic) - Signed Informed Consent after being informed - Increased psychological distress (K10 > 15) - Reduced psychological functioning (WHODAS 2.0 > 16) Exclusion Criteria: - Inability to follow the procedures of the study - Previous enrolment into the current study phase - Participants under tutelage - Acute or severe psychiatric (e.g. schizophrenia) or neurological illness (e.g. dementia) - Imminent suicide risk |
Country | Name | City | State |
---|---|---|---|
Switzerland | Klinik für Konsiliarpsychiatrie und Psychosomatik | Zürich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Bogic M, Njoku A, Priebe S. Long-term mental health of war-refugees: a systematic literature review. BMC Int Health Hum Rights. 2015 Oct 28;15:29. doi: 10.1186/s12914-015-0064-9. — View Citation
Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug. — View Citation
Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available. — View Citation
Fazel M, Wheeler J, Danesh J. Prevalence of serious mental disorder in 7000 refugees resettled in western countries: a systematic review. Lancet. 2005 Apr 9-15;365(9467):1309-14. doi: 10.1016/S0140-6736(05)61027-6. — View Citation
Rahman A, Khan MN, Hamdani SU, Chiumento A, Akhtar P, Nazir H, Nisar A, Masood A, Din IU, Khan NA, Bryant RA, Dawson KS, Sijbrandij M, Wang D, van Ommeren M. Effectiveness of a brief group psychological intervention for women in a post-conflict setting in Pakistan: a single-blind, cluster, randomised controlled trial. Lancet. 2019 Apr 27;393(10182):1733-1744. doi: 10.1016/S0140-6736(18)32343-2. Epub 2019 Apr 1. — View Citation
Sijbrandij M, Acarturk C, Bird M, Bryant RA, Burchert S, Carswell K, de Jong J, Dinesen C, Dawson KS, El Chammay R, van Ittersum L, Jordans M, Knaevelsrud C, McDaid D, Miller K, Morina N, Park AL, Roberts B, van Son Y, Sondorp E, Pfaltz MC, Ruttenberg L, Schick M, Schnyder U, van Ommeren M, Ventevogel P, Weissbecker I, Weitz E, Wiedemann N, Whitney C, Cuijpers P. Strengthening mental health care systems for Syrian refugees in Europe and the Middle East: integrating scalable psychological interventions in eight countries. Eur J Psychotraumatol. 2017 Nov 7;8(sup2):1388102. doi: 10.1080/20008198.2017.1388102. eCollection 2017. — View Citation
Steel Z, Chey T, Silove D, Marnane C, Bryant RA, van Ommeren M. Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA. 2009 Aug 5;302(5):537-49. doi: 10.1001/jama.2009.1132. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of change in self-reported problems | Assessment of change in self-reported problems measured with the PSYCHLOPS. The Psychological Outcomes Profiles (PSYCHLOPS) scale is a patient-generated outcome measure, serving as an indicator of change in response to therapy. Items are rated on a scale from 1 to 5 (respectively 1 - 7) with lower scores indicating greater improvement in self reported problems. | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Other | Exposure to traumatic events | Exposure to traumatic events will be assessed using the Traumatic Events (TE) - a combination of two standardized questionnaires, namely the Life Events Checklist and the Harvard Trauma Questionnaire. | Measured at baseline assessment and 12-months follow up only | |
Other | Reduction of post-migration stressors | Changes in post-migration stressors will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC). Items are rated on a scale from 0 to 4 with lower scores representing fewer post-migration stressors. | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Other | Somatization and somatic symptoms | Somatization and somatic symptoms will be assessed using the Patient Health Questionnaire-15 (PHQ-15). Items are rated on a scale from 1 to 3. Higher scores indicate higher symptom severity. | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Other | Level of integration | Level of integration will be measured using the Immigration Policy Lab Integration Index (IPL-12). | Screening, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Other | General Self-Efficacy | General Self-Efficacy will be assessed using a short form of the General Self-Efficacy Scale (GSE-6). Reponses are given on a scale from 1 to 4 with higher scores representing higher general self-efficacy. | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Other | Attitudes towards mental health | Attitudes towards mental health will be measured with with a set of selected questions (e.g. "Mentally ill people tend to be violent").This questionnaire has been used with Syrian refugees in previous research. | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Other | Impact of COVID-19 pandemic | The impact of the COVID-19 pandemic will be assessed with a set of selected questions regarding medical state, psychological state, financial situation and resources (own questionnaire). | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Other | Cost of Care | The Client Service Receipt Inventory (CSRI) was developed for the collection of data on service utilization and related characteristics of people with mental disorders, as the basis for calculating the costs of care for mental health cost-effectiveness research. | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Other | Access to health care services | A set of question regarding previous contact with the mental health care services and the previous experiences regarding the utilization of any forms of mental support (own questionnaire). | Baseline assessment | |
Other | Assessing the extent to which the strategies taught in PM+ are used before and after the study participation with the Reducing Tension Checklist | The outcome is measured with a nine-item scale that was developed to assess the extent to which the participants perceives that they use the specific strategies, which are trained during the study intervention. The items are rated on a scale from 0 to 4. Higher scores represent greater usage of the strategies. | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment. | |
Primary | Change in psychological distress | Change of psychological distress measured with the Hopkins Symptom Checklist (HSCL-25) serves as primary beneficiary-related health outcome. The 25 items are rated on a scale from 1 to 4. Higher scores indicate more pronounced symptom severity. | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Secondary | Change in posttraumatic stress disorder symptoms | Change in posttraumatic stress disorder symptoms measured with the PTSD Checklist for DSM-5 (PCL-5). Responses are scored on a scale from 0 to 4 with higher scores indicating more pronounced symptom severity. | Baseline assessment, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment | |
Secondary | Change in functional disability | Change in functional disability measured with the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0). The items are rated on a scale from 1 to 5. Higher scores indicate more pronounced functional disability. | Screening, 1 week post-intervention assessment (6 weeks after baseline), 3 month post-intervention assessment (4-4.5 months after baseline), 12 month post intervention assessment |
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