Clinical trial NCT03830008: Scaling-up Psychological Interventions With Syrian Refugees in Switzerland
Official title: Scaling-up Psychological Interventions With Syrian Refugees in Switzerland
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: 2019-02-05
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
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 feasibility of PM+ has never been examined in Switzerland before, this is the aim of the current pilot study.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Verification procedure to the measurement in psychological distress at baseline assessment
timeFrame: baseline assessment (before PM+)
measure: Verification procedure to the measurement in psychological distress after PM+ intervention or ETAU
timeFrame: post-assessment baseline (after PM+/ETAU)
measure: Verification procedure to the measurement in psychological distress 3 months after PM+ intervention or ETAU
timeFrame: 3-months follow-up (after PM+/ETAU)
Secondary outcomes:
measure: Verification procedure to the measurement of symptoms of posttraumatic stress disorder at baseline assessment
timeFrame: baseline assessment (before PM+)
measure: Verification procedure to the measurement of symptoms of posttraumatic stress disorder after PM+ intervention or ETAU
timeFrame: post-assessment baseline (after PM+/ETAU)
measure: Verification procedure to the measurement of symptoms of posttraumatic stress disorder 3 months after PM+ intervention or ETAU
timeFrame: 3-months follow-up (after PM+/ETAU)
measure: Verification procedure to the measurement of functional disability at screening
timeFrame: screening (before PM+)
measure: Verification procedure to the measurement of functional disability after PM+ intervention or ETAU
timeFrame: post-assessment baseline (after PM+/ETAU)
measure: Verification procedure to the measurement of functional disability 3 months after PM+ intervention or ETAU
timeFrame: 3-months follow-up (after PM+/ETAU)
measure: Feasibility of PM+ by the number of dropouts
timeFrame: screening (before PM+)
measure: Feasibility of PM+ by the number of dropouts
timeFrame: baseline assessment (before PM+)
measure: Feasibility of PM+ by the number of dropouts
timeFrame: post-assessment baseline (after PM+/ETAU)
measure: Feasibility of PM+ by the number of dropouts
timeFrame: 3-months follow-up (after PM+/ETAU)
measure: Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
timeFrame: screening (before PM+)
measure: Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
timeFrame: baseline assessment (before PM+)
measure: Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
timeFrame: post-assessment baseline (after PM+/ETAU)
measure: Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments
timeFrame: 3-months follow-up (after PM+/ETAU)
Other outcomes:
measure: Verification procedure to the measurement of change in response to therapy at baseline
timeFrame: baseline assessment (before PM+)
measure: Verification procedure to the measurement of change in response to therapy at post-assessment
timeFrame: post-assessment baseline (after PM+/ETAU)
measure: Verification procedure to the measurement of change in response to therapy 3 months after
timeFrame: 3-months follow-up (after PM+/ETAU)
measure: Post-migration stressors at baseline
timeFrame: baseline assessment (before PM+)
measure: Post-migration stressors at post-assessment
timeFrame: post-assessment baseline (after PM+/ETAU)
measure: Post-migration stressors 3 months after
timeFrame: 3-months follow-up (after PM+/ETAU)
measure: Previous exposure to traumatic events
timeFrame: baseline
measure: Access to Health Care Services (AHCS)
timeFrame: baseline assessment (before PM+)
measure: Medical service utilization of people with mental disorders at baseline
timeFrame: baseline assessment (before PM+)
measure: Medical service utilization of people with mental disorders at post-assessment
timeFrame: post-assessment baseline (after PM+/ETAU)
measure: Medical service utilization of people with mental disorders at post-assessment 3 months after
timeFrame: 3-months follow-up (after PM+/ETAU)
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: ZH
Study officials:
affiliation: University Hospital Zurich / University of Zurich
name: Naser Morina, PhD
role: PRINCIPAL_INVESTIGATOR
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