Completed

NCT Number: NCT04574466

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

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.

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Key information

Conditions

Distress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Common Mental Health Problems Depression Functional Disabilities Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Konsiliarpsychiatrie und Psychosomatik

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Change in psychological distress

Time frame: 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 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.

Secondary outcomes

Change in posttraumatic stress disorder symptoms

Time frame: 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 posttraumatic stress disorder symptoms measured with the PTSD Checklist for DSM-5 (PCL-5). Responses are scored on a scale from 0 to 4 with higher scores indicating more pronounced symptom severity.
Change in functional disability

Time frame: 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

Change in functional disability measured with the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0). The items are rated on a scale from 1 to 5. Higher scores indicate more pronounced functional disability.

Other outcomes

Assessment of change in self-reported problems

Time frame: 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

Assessment of change in self-reported problems measured with the PSYCHLOPS. The Psychological Outcomes Profiles (PSYCHLOPS) scale is a patient-generated outcome measure, serving as an indicator of change in response to therapy. Items are rated on a scale from 1 to 5 (respectively 1 - 7) with lower scores indicating greater improvement in self reported problems.
Exposure to traumatic events

Time frame: Measured at baseline assessment and 12-months follow up only

Exposure to traumatic events will be assessed using the Traumatic Events (TE) - a combination of two standardized questionnaires, namely the Life Events Checklist and the Harvard Trauma Questionnaire.
Reduction of post-migration stressors

Time frame: 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

Changes in post-migration stressors will be assessed using a version of the Post-Migration Living Difficulties Checklist (PMLDC). Items are rated on a scale from 0 to 4 with lower scores representing fewer post-migration stressors.
Somatization and somatic symptoms

Time frame: 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

Somatization and somatic symptoms will be assessed using the Patient Health Questionnaire-15 (PHQ-15). Items are rated on a scale from 1 to 3. Higher scores indicate higher symptom severity.
Level of integration

Time frame: 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

Level of integration will be measured using the Immigration Policy Lab Integration Index (IPL-12).
General Self-Efficacy

Time frame: 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

General Self-Efficacy will be assessed using a short form of the General Self-Efficacy Scale (GSE-6). Reponses are given on a scale from 1 to 4 with higher scores representing higher general self-efficacy.
Attitudes towards mental health

Time frame: 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

Attitudes towards mental health will be measured with with a set of selected questions (e.g. "Mentally ill people tend to be violent").This questionnaire has been used with Syrian refugees in previous research.
Impact of COVID-19 pandemic

Time frame: 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

The impact of the COVID-19 pandemic will be assessed with a set of selected questions regarding medical state, psychological state, financial situation and resources (own questionnaire).
Cost of Care

Time frame: 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

The Client Service Receipt Inventory (CSRI) was developed for the collection of data on service utilization and related characteristics of people with mental disorders, as the basis for calculating the costs of care for mental health cost-effectiveness research.
Access to health care services

Time frame: Baseline assessment

A 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 (own questionnaire).
Assessing the extent to which the strategies taught in PM+ are used before and after the study participation with the Reducing Tension Checklist

Time frame: 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.

The outcome is measured with a nine-item scale that was developed to assess the extent to which the participants perceives that they use the specific strategies, which are trained during the study intervention. The items are rated on a scale from 0 to 4. Higher scores represent greater usage of the strategies.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 5, 2020
Registry last updated: May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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