Elaine Marieb College of Nursing, University of Massachusetts Amherst, Amherst, Massachusetts, USA
Elaine Marieb College of Nursing, University of Massachusetts Amherst, Amherst, Massachusetts, USA.
BMJ Open. 2022 May 3;12(5):e061353. doi: 10.1136/bmjopen-2022-061353.
Research is needed to investigate preventive strategies to reduce mental health burden and assess effective implementation among immigrants. Problem management plus (PMP) is a low-intensity multicomponent psychological intervention developed by the World Health Organization (WHO) that trained laypeople can deliver. PMP has been adapted as a prevention intervention and developed as PMP for immigrants (PMP-I), including psychoeducation, problem-solving, behavioural activations and mind-body exercise, to address immigrants' multiple stressors. This pilot trial aims to assess the feasibility and acceptability of PMP-I and provide a preliminary estimate of the difference between PMP-I versus community support services pamphlets on the primary outcomes of interest (stress, anxiety and depressive symptoms) to inform the design of a large-scale intervention.
The feasibility and acceptability of PMP-I will be assessed by measuring recruitment, session attendance, retention rates, programme acceptability and the fidelity of intervention delivery. This pilot trial will test preliminary effects of PMP-I vs community support services pamphlets in a randomised controlled trial (N=232 participants from 116 families (2 members/family); 58 families randomised to condition intervention or control) on stress, anxiety and depressive symptoms (primary outcomes), chronic physiological stress assessed in hair cortisol (secondary outcomes), and coping, family conflict resolution, and social networking (targets), with assessment at baseline, postintervention and 3-month postintervention. Eligibility criteria for the primary study participants include Bhutanese ≥18 years resettled in Massachusetts with a score of ≤14 on the Patient Health Questionnaire-9. All family members will be invited to participate in the family-based intervention (one session/week for 5 weeks). Multilevel modelling will compare the longitudinal change in outcomes for each treatment arm.
The Institutional Review Board of the University of Massachusetts Amherst approved this study (Protocol: 1837). Written informed consent will be obtained from all participants. The study results will be used to inform the design of a large-scale intervention and will be disseminated in peer-reviewed journals and conferences.
NCT04453709.
需要研究预防策略，以减轻移民的心理健康负担，并评估其实施效果。问题管理加（PMP）是世界卫生组织（WHO）开发的一种低强度多成分心理干预措施，经过培训的非专业人员可以提供这种干预。PMP 已被改编为预防干预措施，并开发为移民问题管理加（PMP-I），包括心理教育、解决问题、行为激活和身心锻炼，以解决移民的多种压力源。这项初步试验旨在评估 PMP-I 的可行性和可接受性，并初步估计 PMP-I 与社区支持服务小册子在主要关注结果（压力、焦虑和抑郁症状）方面的差异，为大规模干预措施的设计提供信息。
将通过衡量招募、参加课程、保留率、计划接受度和干预措施交付的保真度来评估 PMP-I 的可行性和可接受性。这项初步试验将在一项随机对照试验（N=232 名参与者，来自 116 个家庭（每个家庭 2 人）；58 个家庭随机分配到干预组或对照组）中测试 PMP-I 与社区支持服务小册子的初步效果，评估压力、焦虑和抑郁症状（主要结果）、头发皮质醇评估的慢性生理压力（次要结果），以及应对、家庭冲突解决和社交网络（目标），评估时间为基线、干预后和干预后 3 个月。主要研究参与者的入选标准包括在马萨诸塞州重新定居的不丹人，年龄≥18 岁，患者健康问卷-9 得分为≤14。所有家庭成员都将被邀请参加家庭为基础的干预措施（每周一次，为期 5 周）。多层次模型将比较每个治疗臂的结果的纵向变化。
马萨诸塞大学阿默斯特分校的机构审查委员会批准了这项研究（方案：1837）。将从所有参与者那里获得书面知情同意。研究结果将用于指导大规模干预措施的设计，并将在同行评议的期刊和会议上发表。
NCT04453709。
