Department of Neuroscience, Biomedicine, and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona, Verona, Italy.
Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
Front Public Health. 2023 Jan 25;11:1100546. doi: 10.3389/fpubh.2023.1100546. eCollection 2023.
Migrant populations, including workers, undocumented migrants, asylum seekers, refugees, internationally displaced persons, and other populations on the move, are exposed to a variety of stressors and potentially traumatic events before, during, and after the migration process. In recent years, the COVID-19 pandemic has represented an additional stressor, especially for migrants on the move. As a consequence, migration may increase vulnerability of individuals toward a worsening of subjective wellbeing, quality of life, and mental health, which, in turn, may increase the risk of developing mental health conditions. Against this background, we designed a stepped-care programme consisting of two scalable psychological interventions developed by the World Health Organization and locally adapted for migrant populations. The effectiveness and cost-effectiveness of this stepped-care programme will be assessed in terms of mental health outcomes, resilience, wellbeing, and costs to healthcare systems.
We present the study protocol for a pragmatic randomized study with a parallel-group design that will enroll participants with a migrant background and elevated level of psychological distress. Participants will be randomized to care as usual only or to care a usual plus a guided self-help stress management guide (Doing What Matters in Times of Stress, DWM) and a five-session cognitive behavioral intervention (Problem Management Plus, PM+). Participants will self-report all measures at baseline before random allocation, 2 weeks after DWM delivery, 1 week after PM+ delivery and 2 months after PM+ delivery. All participants will receive a single-session of a support intervention, namely Psychological First Aid. We will include 212 participants. An intention-to-treat analysis using linear mixed models will be conducted to explore the programme's effect on anxiety and depression symptoms, as measured by the Patient Health Questionnaire-Anxiety and Depression Scale summary score 2 months after PM+ delivery. Secondary outcomes include post-traumatic stress disorder symptoms, resilience, quality of life, resource utilization, cost, and cost-effectiveness.
This study is the first randomized controlled trial that combines two World Health Organization psychological interventions tailored for migrant populations with an elevated level of psychological distress. The present study will make available DWM/PM+ packages adapted for remote delivery following a task-shifting approach, and will generate evidence to inform policy responses based on a more efficient use of resources for improving resilience, wellbeing and mental health.
ClinicalTrials.gov, identifier: NCT04993534.
移民群体包括工人、无证移民、寻求庇护者、难民、国际流离失所者和其他流动人口，他们在移民过程之前、期间和之后都面临着各种压力源和潜在的创伤性事件。近年来，COVID-19 大流行是另一个压力源，尤其是对流动移民而言。因此，移民可能会增加个人的脆弱性，导致主观幸福感、生活质量和心理健康恶化，从而增加患心理健康疾病的风险。在此背景下，我们设计了一个由世界卫生组织开发并针对移民群体进行了本地化调整的两个可扩展的心理干预措施组成的阶梯式护理方案。该阶梯式护理方案的有效性和成本效益将根据心理健康结果、韧性、幸福感和对医疗保健系统的成本进行评估。
我们介绍了一项实用随机研究的研究方案，该研究采用平行组设计，将招募具有移民背景和较高心理困扰水平的参与者。参与者将被随机分配接受常规护理或常规护理加自我指导的压力管理指南（在压力时期做重要的事情，DWM）和五节认知行为干预（问题管理加，PM+）。参与者将在随机分配前、DWM 交付后 2 周、PM+交付后 1 周和 PM+交付后 2 个月时自我报告所有措施。所有参与者将接受单次支持干预，即心理急救。我们将纳入 212 名参与者。采用线性混合模型的意向治疗分析将用于探索该方案对 PM+交付后 2 个月时患者健康问卷焦虑和抑郁量表总分的焦虑和抑郁症状的影响。次要结果包括创伤后应激障碍症状、韧性、生活质量、资源利用、成本和成本效益。
这是第一项结合了针对心理困扰移民群体的两种世界卫生组织心理干预措施的随机对照试验。本研究将提供适应远程交付的 DWM/PM+ 包，采用任务转移方法，并根据更有效地利用资源来提高韧性、幸福感和心理健康的情况提供证据，为政策应对提供信息。
ClinicalTrials.gov，标识符：NCT04993534。
