Depression Clinical Trial
— STRENGTHS_CHOfficial title:
Scaling-up Psychological Interventions With Syrian Refugees in Switzerland
Verified date | February 2021 |
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 feasibility of PM+ has never been examined in Switzerland before, this is the aim of the current pilot study.
Status | Completed |
Enrollment | 59 |
Est. completion date | March 20, 2020 |
Est. primary completion date | March 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male and female Syrian refugees or asylum seekers who entered Switzerland after the beginning of Syrian Civil War in March 2011 - = 18 years of age - Arabic-speaking - 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 - Previous or currently enrolment of a family member into the current study - Participants under tutelage - Acute or severe psychiatric (e.g. schizophrenia) or neurological illness (e.g. dementia) - Imminent suicide risk |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich | Zürich | ZH |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
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. — View Citation
Dua T, Barbui C, Clark N, Fleischmann A, Poznyak V, van Ommeren M, Yasamy MT, Ayuso-Mateos JL, Birbeck GL, Drummond C, Freeman M, Giannakopoulos P, Levav I, Obot IS, Omigbodun O, Patel V, Phillips M, Prince M, Rahimi-Movaghar A, Rahman A, Sander JW, Saunders JB, Servili C, Rangaswamy T, Unützer J, Ventevogel P, Vijayakumar L, Thornicroft G, Saxena S. Evidence-based guidelines for mental, neurological, and substance use disorders in low- and middle-income countries: summary of WHO recommendations. PLoS Med. 2011 Nov;8(11):e1001122. doi: 10.1371/journal.pmed.1001122. Epub 2011 Nov 15. — View Citation
Guidelines for the Management of Conditions Specifically Related to Stress. Geneva: World Health Organization; 2013. — View Citation
Hassan, G., Kirmayer, L. J., Mekki-Berrada, A., Quosh, C., el Chammay, R., Deville-Stoetzel, J., . . . Coutts, A. (2015). Culture, context and the mental health and psychosocial wellbeing of Syrians: a review for mental health and psychosocial support staff working with Syrians affected by armed conflict. Geneva: UNHCR.
mhGAP Intervention Guide for Mental, Neurological and Substance Use Disorders in Non-Specialized Health Settings: Mental Health Gap Action Programme (mhGAP): Version 2.0. Geneva: World Health Organization; 2016. — View Citation
Mollica RF, Caspi-Yavin Y, Bollini P, Truong T, Tor S, Lavelle J. The Harvard Trauma Questionnaire. Validating a cross-cultural instrument for measuring torture, trauma, and posttraumatic stress disorder in Indochinese refugees. J Nerv Ment Dis. 1992 Feb;180(2):111-6. — View Citation
Rahman A, Riaz N, Dawson KS, Usman Hamdani S, Chiumento A, Sijbrandij M, Minhas F, Bryant RA, Saeed K, van Ommeren M, Farooq S. Problem Management Plus (PM+): pilot trial of a WHO transdiagnostic psychological intervention in conflict-affected Pakistan. World Psychiatry. 2016 Jun;15(2):182-3. doi: 10.1002/wps.20312. — 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. Review. — 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. Review. — View Citation
Tol WA, Barbui C, van Ommeren M. Management of acute stress, PTSD, and bereavement: WHO recommendations. JAMA. 2013 Aug 7;310(5):477-8. doi: 10.1001/jama.2013.166723. — View Citation
Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P., Marx, B., & Schnurr, P. (2013). The ptsd checklist for dsm-5 (pcl-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Verification procedure to the measurement of change in response to therapy at baseline | patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale [PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored [likert-scale 0 to 5 from "severely affected" to "not at all affected"); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.] | baseline assessment (before PM+) | |
Other | Verification procedure to the measurement of change in response to therapy at post-assessment | patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale [PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored [likert-scale 0 to 5 from "severely affected" to "not at all affected"); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.] | post-assessment baseline (after PM+/ETAU) | |
Other | Verification procedure to the measurement of change in response to therapy 3 months after | patient-generated outcome measure by the Psychological Outcomes Profiles (PSYCHLOPS) scale [PSYCHLOPS has questions on Problems, Function and Wellbeing. Participants are asked to describe their main Problem or Problems and how this affects them (Function). Responses to all questions are scored [likert-scale 0 to 5 from "severely affected" to "not at all affected"); it is a highly sensitive measure of change during the course of psychotherapeutic interventions.] | 3-months follow-up (after PM+/ETAU) | |
Other | Post-migration stressors at baseline | will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC) | baseline assessment (before PM+) | |
Other | Post-migration stressors at post-assessment | will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC) | post-assessment baseline (after PM+/ETAU) | |
Other | Post-migration stressors 3 months after | will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC) | 3-months follow-up (after PM+/ETAU) | |
Other | Previous exposure to traumatic events | assessed using the Traumatic Events (TE) - a combination of two standardized questionnaires, namely the Life Events Checklist (LEC) (Weathers et al., 2013) and the Harvard Trauma Questionnaire (HTQ) (Mollica et al., 1992). HTQ consists of 3 sections with 48 questions. LEC consists of 17 question. Single questions from HTQ (Section 1) and LEC are summarized to the sequence of 27 questions (about experienced trauma or adversities with yes/no answer format). The number of positive answers is the outcome value. | baseline | |
Other | Access to Health Care Services (AHCS) | The 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 | baseline assessment (before PM+) | |
Other | Medical service utilization of people with mental disorders at baseline | accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research | baseline assessment (before PM+) | |
Other | Medical service utilization of people with mental disorders at post-assessment | accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research | post-assessment baseline (after PM+/ETAU) | |
Other | Medical service utilization of people with mental disorders at post-assessment 3 months after | accessed using the Client Service Receipt Inventory (CSRI) as the basis for calculating the costs of care for mental health cost-effectiveness research | 3-months follow-up (after PM+/ETAU) | |
Primary | Verification procedure to the measurement in psychological distress at baseline assessment | measured by the Hopkins Symptom Checklist (HSCL-25) | baseline assessment (before PM+) | |
Primary | Verification procedure to the measurement in psychological distress after PM+ intervention or ETAU | measured by the Hopkins Symptom Checklist (HSCL-25) | post-assessment baseline (after PM+/ETAU) | |
Primary | Verification procedure to the measurement in psychological distress 3 months after PM+ intervention or ETAU | measured by the Hopkins Symptom Checklist (HSCL-25) | 3-months follow-up (after PM+/ETAU) | |
Secondary | Verification procedure to the measurement of symptoms of posttraumatic stress disorder at baseline assessment | measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) | baseline assessment (before PM+) | |
Secondary | Verification procedure to the measurement of symptoms of posttraumatic stress disorder after PM+ intervention or ETAU | measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) | post-assessment baseline (after PM+/ETAU) | |
Secondary | Verification procedure to the measurement of symptoms of posttraumatic stress disorder 3 months after PM+ intervention or ETAU | measured using the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) | 3-months follow-up (after PM+/ETAU) | |
Secondary | Verification procedure to the measurement of functional disability at screening | assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0) | screening (before PM+) | |
Secondary | Verification procedure to the measurement of functional disability after PM+ intervention or ETAU | assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0) | post-assessment baseline (after PM+/ETAU) | |
Secondary | Verification procedure to the measurement of functional disability 3 months after PM+ intervention or ETAU | assessed by the WHODAS 2.0 (WHO Disability Assessment Schedule 2.0) | 3-months follow-up (after PM+/ETAU) | |
Secondary | Feasibility of PM+ by the number of dropouts | Monitoring of the dropouts by number of patients | screening (before PM+) | |
Secondary | Feasibility of PM+ by the number of dropouts | Monitoring of the dropouts by number of patients | baseline assessment (before PM+) | |
Secondary | Feasibility of PM+ by the number of dropouts | Monitoring of the dropouts by number of patients | post-assessment baseline (after PM+/ETAU) | |
Secondary | Feasibility of PM+ by the number of dropouts | Monitoring of the dropouts by number of patients | 3-months follow-up (after PM+/ETAU) | |
Secondary | Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments | Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback) | screening (before PM+) | |
Secondary | Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments | Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback) | baseline assessment (before PM+) | |
Secondary | Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments | Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback) | post-assessment baseline (after PM+/ETAU) | |
Secondary | Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments | Monitoring of wrong understanding or wrong translation (by number of patients and the scope of the feedback) | 3-months follow-up (after PM+/ETAU) |
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