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临床试验/NCT03830008
NCT03830008已完成不适用

Scaling-up Psychological Interventions With Syrian Refugees in Switzerland

University of Zurich2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2018年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Verification procedure to the measurement in psychological distress after PM+ intervention or ETAU

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

All instruments and questions will be administered using tablets by trained research staff blind to the allocation status of the participants.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Verification procedure to the measurement in psychological distress after PM+ intervention or ETAU

时间窗: post-assessment baseline (after PM+/ETAU)

measured by the Hopkins Symptom Checklist (HSCL-25)

Verification procedure to the measurement in psychological distress at baseline assessment

时间窗: baseline assessment (before PM+)

measured by the Hopkins Symptom Checklist (HSCL-25)

Verification procedure to the measurement in psychological distress 3 months after PM+ intervention or ETAU

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

measured by the Hopkins Symptom Checklist (HSCL-25)

次要结局

  • Feasibility of PM+ by feedbacks regarding the understanding of intervention and measurements instruments(3-months follow-up (after PM+/ETAU))
  • Verification procedure to the measurement of symptoms of posttraumatic stress disorder at baseline assessment(baseline assessment (before PM+))
  • Verification procedure to the measurement of functional disability at screening(screening (before PM+))
  • Verification procedure to the measurement of functional disability 3 months after PM+ intervention or ETAU(3-months follow-up (after PM+/ETAU))
  • 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 after PM+ intervention or ETAU(post-assessment baseline (after PM+/ETAU))
  • Feasibility of PM+ by the number of dropouts(3-months follow-up (after PM+/ETAU))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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