Scaling-up Psychological Interventions With Syrian Refugees in Switzerland

Depression Clinical Trial

— STRENGTHS_CH  

Official title:

Scaling-up Psychological Interventions With Syrian Refugees in Switzerland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830008
• Other study ID #: BASEC-2017-01175
• Status: Completed
• Phase: N/A
• Start date: December 21, 2018
• Est. completion date: March 20, 2020

Study information

• Verified date: February 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Recent crises in the Middle East, most notably in Syria, have resulted in an unprecedented increase in the worldwide number of refugees and asylum seekers. Switzerland (CH) is strongly affected by this crisis too. Eight percent of asylum requests in 2016 were made by people from Syria (2015: 12 %). More than 7'000 asylum seekers from Syria entered CH over the last two years. Due to the ongoing war in this region, it is unlikely that this kind of migration and flight will stop. Notably, 50% of the refugee population are children and adolescents.

Refugees have typically been exposed to multiple stressors related to war and displacement including loss of family members, destruction of homes and livelihoods and human rights violations such as sexual violence or torture. They have often undertaken a risky and stressful flight leaving their homes for an unknown future. Accordingly, studies consistently show that refugees are at considerable risk of developing common mental disorders, including depression, anxiety, posttraumatic stress disorder (PTSD) and related somatic health symptoms. Recent WHO projections suggest that approximately 15-20% of Syrian refugees will develop some type of mental health problem and therefore represent an enormous public mental health challenge.

According to the UNHCR, 86% of all displaced persons remain in conflict or neighboring countries where appropriate health care is mostly not available. But also Western health systems are often unable to appropriately cover the needs of this particularly vulnerable population regarding prevention and treatment of mental health problems. As a response to this situation, the WHO developed the low-intensity Problem Management Plus (PM+) programs, a new generation of shorter, less expensive and trans-diagnostic (i.e., not specifically aimed at treating a certain mental disorder) programs to reduce common mental health symptoms and improve psychosocial functioning. PM+ is based on the WHO treatment guidelines for conditions related to stress. PM+ is a 5-sessions intervention aimed at reducing symptoms of depression, anxiety, PTSD, and related conditions, is delivered by trained non-specialized workers or lay people, and is available in individual and group delivery formats for both children and adults. It comprises evidence-based techniques of (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support. PM+ has been successfully implemented in Kenya and Pakistan.

The STRENGTHS (Syrian REfuGees MeNTal HealTH Care Systems) study aims at evaluating the effectiveness and implementation of PM+ with Syrian refugees in different settings in low- and high-resource countries. The study consortium includes international experts in the domains of trauma and public mental health as well as representatives of WHO and UNHCR. The Zürich study site has been consigned to examine PM+ with adult refugees in an individual treatment setting in Switzerland. At the same time, similar studies in other countries will be undertaken. Despite the objective of these studies to implement and evaluate the effectiveness of PM+ in refugees, each research institution acts independently. Moreover, the other studies will be completed in different treatment settings - i.e., in children and adolescents (Lebanon), in groups (Turkey and Netherlands), and internet-delivered PM+ (Germany and Egypt).

To date, the feasibility of PM+ has not been investigated in a highly industrialized country, such as Switzerland.

In the present study, the investigators will evaluate the feasibility of PM+ in Syrian refugees in Switzerland.

This research entails single-blind randomized controlled trial.

The amendment was secured by December 2018. Trainers, assessors, supervisors and helpers are already identified, recruited an trained.

After the approval, the first participants will be identified, invited to screening and if they fulfill the criteria they will be invited to participate in the pilot study. The pilot study will end by the end of 2019. After the pilot study the results will be evaluated, analyzed and integrated in the planning of the definitive randomized controlled trial (RCT) (next study, not the part of current registration).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anxiety
• Common Mental Health Problems
• Depression
• Distress
• Functional Disabilities
• PTSD
• Trauma

Intervention

Behavioral:
• Problem Management Plus
PM+ is a new, brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (11)

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

Outcome

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)

External Links

•   Problem Management Plus (PM+) Individual psychological help for adults impaired by distress in communities exposed to adversity