Scaling-up Psychological Interventions With Syrian Refugees in Switzerland

NCT03830008 | Completed DMC

• 1 other identifier: BASEC-2017-01175
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Problem Management Plus; Distress; Mental Health Care; Low-intensity; Refugees

Outcome Measures

Primary Outcomes (3)

• Verification procedure to the measurement in psychological distress at baseline assessment

  measured by the Hopkins Symptom Checklist (HSCL-25)

  baseline assessment (before PM+)

• 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)

• 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 Outcomes (14)

• Verification procedure to the measurement of symptoms of posttraumatic stress disorder at baseline assessment

  baseline assessment (before PM+)

• Verification procedure to the measurement of symptoms of posttraumatic stress disorder after PM+ intervention or ETAU

  post-assessment baseline (after PM+/ETAU)

• Verification procedure to the measurement of symptoms of posttraumatic stress disorder 3 months after PM+ intervention or ETAU

  3-months follow-up (after PM+/ETAU)

• Verification procedure to the measurement of functional disability at screening

  screening (before PM+)

• Verification procedure to the measurement of functional disability after PM+ intervention or ETAU

  post-assessment baseline (after PM+/ETAU)

Other Outcomes (11)

• Verification procedure to the measurement of change in response to therapy at baseline

  baseline assessment (before PM+)

• Verification procedure to the measurement of change in response to therapy at post-assessment

  post-assessment baseline (after PM+/ETAU)

• Verification procedure to the measurement of change in response to therapy 3 months after

  3-months follow-up (after PM+/ETAU)

Study Arms (2)

Enhanced Treatment As Usual (ETAU)

NO INTERVENTION

The control group will receive enhanced treatment as usual (ETAU). ETAU means that the research team will advise the participants to contact their doctor in case of physical or mental health problems. Moreover, the research team will hand over the list with the general practitioners (GP) in the neighborhood of the participant and the written information (official booklet) about the operating of the Swiss health care system. Adequate treatment will be provided by this physician, usually, a general practitioner who acts as a gate-keeper (an asylum seeker or refugee has to go first to his/her assigned GP in order to get access to the health care system).

Problem Management Plus

EXPERIMENTAL

PM+ is a new, brief, psychological intervention program based on Cognitive Behaviour Therapy (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.

Behavioral: Problem Management Plus

Interventions

Problem Management Plus BEHAVIORAL

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.

Problem Management Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8006, Switzerland

Location

Related Publications (11)

• 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.

  PMID: 29163867 BACKGROUND

• 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.

  PMID: 26407793 BACKGROUND

• 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.

  BACKGROUND

• Guidelines for the Management of Conditions Specifically Related to Stress. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK159725/

  PMID: 24049868 BACKGROUND

• 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. No abstract available.

  PMID: 27265713 BACKGROUND

• 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.

  PMID: 19654388 BACKGROUND

• 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, Unutzer 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.

  PMID: 22110406 BACKGROUND

• 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. No abstract available.

  PMID: 23925613 BACKGROUND

• 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK390828/

  PMID: 27786430 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 1737972 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Naser Morina, PhD

  University Hospital Zurich / University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All instruments and questions will be administered using tablets by trained research staff blind to the allocation status of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The exploratory RCT will inform us about the feasibility, safety, and delivery of the intervention; this will identify issues around its training, supervision and outcome measures. After the baseline assessment, sixty participants (N = 60) will be involved in the exploratory RCT (assigned to either the PM+ intervention (n=30) or the ETAU control condition (n=30)). The investigators intend to deliver the intervention to 30 participants, allowing us to test the feasibility and acceptability of the intervention in the proposed setting and inform the sample size for a future definitive trial.

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: February 5, 2019
• Study Start: December 21, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

CH (1)