Clinical trial NCT04574466: Scaling-up Psychological Interventions With Syrian Refugees in Switzerland (STRENGTHS_CH): RCT
Official title: Scaling-up Psychological Interventions With Syrian Refugees in Switzerland: RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress
PTSD
Anxiety
Depression
Trauma
Functional Disabilities
Common Mental Health Problems
Keywords: Problem Management Plus
Distress
Mental Health Care
Low-intensity
Refugees
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)).
Primary purpose: TREATMENT

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.

Detailed description: Recent crises in the Middle East have resulted in an unprecedented increase in the worldwide number of refugees and asylum seekers. Switzerland (CH) is strongly affected by this crisis too.There are currently about 19'000 Syrian refugees and asylum seekers in Switzerland. A similar number of other Arabic-speaking individuals have applied for asylum in Switzerland since 2011. Due to the ongoing war in the MENA region, it is unlikely that this kind of migration and flight will resolve within the next years.

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, various studies have shown that refugees are at considerable risk of developing common mental disorders, including depression, anxiety, posttraumatic stress disorder (PTSD) and related somatic health symptoms.

According to the UNHCR, 85% of all displaced persons are hosted in third-world countries where appropriate mental health care is often not available. However, Western health systems are also 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 short, resource-sparing, 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 tested for effectiveness 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 effectiveness and implementation of PM+ has not been investigated in a highly industrialized country, such as Switzerland.

In the present study, the investigators will evaluate the effectiveness and implementation of PM+ in Arabic speaking refugees in Switzerland.

Eligibility criteria: 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

Primary outcomes:
measure: Change in psychological distress
timeFrame: 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:
measure: Change in posttraumatic stress disorder symptoms
timeFrame: 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
measure: Change in functional disability
timeFrame: 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:
measure: Assessment of change in self-reported problems
timeFrame: 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
measure: Exposure to traumatic events
timeFrame: Measured at baseline assessment and 12-months follow up only
measure: Reduction of post-migration stressors
timeFrame: 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
measure: Somatization and somatic symptoms
timeFrame: 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
measure: Level of integration
timeFrame: 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
measure: General Self-Efficacy
timeFrame: 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
measure: Attitudes towards mental health
timeFrame: 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
measure: Impact of COVID-19 pandemic
timeFrame: 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
measure: Cost of Care
timeFrame: 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
measure: Access to health care services
timeFrame: Baseline assessment
measure: Assessing the extent to which the strategies taught in PM+ are used before and after the study participation with the Reducing Tension Checklist
timeFrame: 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.
Locations:
city: Zürich
country: Switzerland
facility: Klinik für Konsiliarpsychiatrie und Psychosomatik
Study officials:
affiliation: Klinik für Konsiliarpsychiatrie und Psychosomatik
name: Naser Morina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: 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.