Scaling-up Psychological Interventions With Syrian Refugees in Switzerland (STRENGTHS_CH): RCT

NCT04574466 | Completed DMC

• 1 other identifier: BASEC-2017-01175-rct
• Study Type: interventional
• Target: 54
• 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 effectiveness and implementation of PM+ has never been examined in Switzerland before, this is the aim of the current randomized controlled trial.

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 (1)

• 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 Outcomes (2)

• Change in posttraumatic stress disorder symptoms

  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

• Change in 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

Other Outcomes (11)

• Assessment of change 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

• Exposure to traumatic events

  Measured at baseline assessment and 12-months follow up only

• Reduction of 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

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 written information (official booklet) about the operating of the Swiss health care system. Adequate treatment will be provided by a 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

The participants who are assigned to the intervention group will receive five sessions of PM+, a psychological intervention which has been developed by the WHO. PM+ is a new short, transdiagnostic (i.e., not specifically aimed at treating a certain mental disorder) program aiming to reduce common mental health symptoms and improve psychosocial functioning. 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, and accessing social support. These elements have been recommended in recent WHO guidelines. PM+ has proven to be effective by two randomized controlled trials (RCTs) in Kenya and Pakistan.

Behavioral: Problem Management Plus

Interventions

Problem Management Plus 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.

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 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Klinik für Konsiliarpsychiatrie und Psychosomatik

Zurich, 8091, Switzerland

Location

Related Publications (7)

• 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

• 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

• 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.

  PMID: 30948286 BACKGROUND

• 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.

  PMID: 28809935 BACKGROUND

• 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.

  PMID: 15823380 BACKGROUND

• 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.

  PMID: 26510473 BACKGROUND

Related Links

• Staatssekretariat für Migration. (2020a). Asylstatistik 2019.
• Staatssekretariat für Migration. (2020b). Asylstatistik (nach Nationen).
• UNHCR (2020). Figures at a Glance.

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

  Klinik für Konsiliarpsychiatrie und Psychosomatik

  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 definitive RCT will inform us about the effectiveness and implementation of the intervention. After the baseline assessment, three hundred eighty participants (N = 380) will be involved in the exploratory RCT (assigned to either the PM+ intervention (n=190) or the ETAU control condition (n=190)).

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 5, 2020
• Study Start: August 25, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

CH (1)