Liverpool Clinical Trials Centre, University of Liverpool, Institute in the Park, Alder Hey Children's NHS Foundation Trust, Liverpool, L12 2AP, UK.
PRIME Centre Wales, Health Services Research Team, Swansea University Medical School, Institute of Life Sciences 2, Floor 2, Singleton Park, Swansea, SA2 8PP, UK.
Trials. 2020 Apr 28;21(1):367. doi: 10.1186/s13063-020-04310-5.
Asylum seekers and refugees (AS&Rs) experience impaired mental health and wellbeing, related to stresses in their country of origin, experiences in transit and reception on arrival, including significant barriers to accessing mainstream services. Their contact with health care is often crisis-driven and mediated through non-governmental organisations (NGOs). Problem Management Plus (PM+) is a psychosocial intervention recommended by the World Health Organisation to address distress experienced by adults affected by humanitarian crises. We are investigating its application for the first time in a high-income country.
In a pilot randomised controlled trial (RCT), PM+ will be delivered to AS&Rs in contact with NGOs in Liverpool City Region, UK by lay therapists who have lived experience of forced migration. Following systematic review and stakeholder engagement, PM+ has been adapted to the local context, and lay therapists have been trained in its delivery. We will assess the feasibility of conducting a three-arm RCT of five 90-min sessions of PM+, delivered individually or in groups by lay therapists to AS&Rs experiencing emotional distress and functional impairment, compared with each other and with usual support offered by local NGOs. Distress and impairment at baseline will be measured by the Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule (WHO-DAS). We aim to recruit 105 participants, 35 per arm. Primary health outcomes are anxiety and depressive symptoms at 3 months, measured by HADS. Secondary outcomes include subjective wellbeing, functional status, progress on identified problems, presence of post-traumatic stress disorder and depressive disorder and service usage. Longer-term impact will be assessed at 6 months post baseline, on the same parameters. We will assess the feasibility of conducting a full RCT in relation to the following elements: recruitment and retention of lay therapists and study participants; fidelity of delivery of PM+; and suitability of the study measures, including any linguistic or cultural barriers.
We will use these findings to specify the parameters for a full RCT to test the effectiveness and cost-effectiveness of PM+ in reducing emotional distress and health inequalities, and improving functional ability and wellbeing, amongst asylum seekers and refugees.
ISRCTN, ID: ISRCTN15214107. Registered on 10 September 2019.
寻求庇护者和难民(AS&Rs)经历了心理健康和福利受损,这与他们原籍国的压力、过境和抵达时的接待经历有关,包括获得主流服务的重大障碍。他们与医疗保健的接触通常是由危机驱动的,并通过非政府组织(NGO)进行调解。问题管理加(PM+)是世界卫生组织推荐的一种心理社会干预措施,用于解决受人道主义危机影响的成年人所经历的痛苦。我们正在首次在高收入国家对此进行应用研究。
在一项试点随机对照试验(RCT)中,PM+将由在利物浦地区与非政府组织有联系的、具有强制移民生活经验的非专业治疗师提供给寻求庇护者和难民。在系统审查和利益相关者参与之后,PM+已适应当地情况,并且非专业治疗师已接受其提供的培训。我们将评估对 105 名参与者进行三臂 RCT 的可行性,这些参与者经历了情绪困扰和功能障碍,将比较彼此之间以及与当地非政府组织提供的常规支持的差异,将由非专业治疗师提供五节 90 分钟的 PM+个体或小组治疗。使用医院焦虑和抑郁量表(HADS)和世界卫生组织残疾评估表(WHO-DAS)在基线时评估困扰和功能障碍。我们的目标是招募 35 名参与者/臂,共 105 名参与者。主要的健康结果是 3 个月时的焦虑和抑郁症状,使用 HADS 进行测量。次要结果包括主观幸福感、功能状态、已确定问题的进展、创伤后应激障碍和抑郁障碍的存在以及服务使用情况。将在基线后 6 个月评估更长期的影响,使用相同的参数。我们将评估与以下要素相关的全 RCT 可行性:招募和保留非专业治疗师和研究参与者;PM+的交付保真度;以及研究措施的适用性,包括任何语言或文化障碍。
我们将使用这些发现来确定全 RCT 的参数,以测试 PM+在减少情绪困扰和健康不平等、改善寻求庇护者和难民的功能能力和幸福感方面的有效性和成本效益。
ISRCTN,ID:ISRCTN85456051。于 2019 年 9 月 10 日注册。