Protocol for a feasibility study of group-based focused psychosocial support to improve the psychosocial well-being and functioning of adults affected by humanitarian crises in Nepal: Group Problem Management Plus (PM+)
Protocol for a feasibility study of group-based focused psychosocial support to improve the psychosocial well-being and functioning of adults affected by humanitarian crises in Nepal: Group Problem Management Plus (PM+)
复制标题
基于团体的重点社会心理支持的可行性研究协议，以改善尼泊尔受人道主义危机影响的成年人的社会心理福祉和功能：团体问题管理增强版（PM）
作者：
M. Sangraula;E. Van't Hof;N. Luitel;E. Turner;K. Marahatta;J. Nakao;M. van Ommeren;M. Jordans;B. Kohrt
背景 在人道主义紧急情况下，常见精神障碍的患病率增加，而解决这些问题的服务却减少了。问题管理升级版 (PM+) 是一种简短的五次跨诊断心理世界卫生组织干预措施，采用经验支持的策略，可以由非专业非专业服务提供者在专家监督下向遭受痛苦的成年人提供。最近在巴基斯坦和肯尼亚进行的两项随机对照试验证明了单独递送 PM+ 的功效。为了使 PM+ 在不同环境下更具可扩展性和可接受性，开发一个由 6-8 名参与者参加的小组版本也很重要。需要进行一项研究来证明新文化背景下的干预措施以及在整群随机对照试验中评估 PM+ 组的程序的可行性和可接受性。方法本方案描述了在尼泊尔 Sindhuli 进行的 PM+ 组的可行性试验。本研究将评估以村庄发展委员会（VDC）为随机化单位的整群随机对照试验（c-RCT）程序，该委员会是政府行政管理的第二小单位。心理困扰和功能障碍程度较高的成年人将接受 PM+ 组（n = 60）或强化常规护理（EUC；n = 60）。将在筛查、治疗前基线以及干预后 7-10 天期间测量心理困扰、功能障碍、抑郁症状、创伤后应激障碍 (PTSD) 症状和感知问题。将从受益人、其家人、当地利益相关者和工作人员处收集定性数据，以支持定量数据并确定主题，报告那些参与和/或受 Group PM+ 影响的人认为该方案是可接受的、可行的和有用的。该试验的主要目的是评估干预措施的可接受性和可行性；确定当地适应方法、培训、监督和成果措施实施方面的问题；讨论该试验的结果将有助于通过文化适应和干预的情境化来优化可行性和可接受性，以及完善 c-RCT 的设计，这将评估 Group PM+ 在尼泊尔的有效性。试验注册ClinicalTrials.gov 标识符：NCT03359486
BackgroundThe prevalence of common mental disorders increases in humanitarian emergencies while access to services to address them decreases. Problem Management Plus (PM+) is a brief five-session trans-diagnostic psychological WHO intervention employing empirically supported strategies that can be delivered by non-specialist lay-providers under specialist supervision to adults impaired by distress. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the efficacy of individually delivered PM+. To make PM+ more scalable and acceptable in different contexts, it is important to develop a group version as well, with 6–8 participants in session. A study is needed to demonstrate the feasibility and acceptability of both the intervention in a new cultural context and the procedures to evaluate Group PM+ in a cluster randomized controlled trial.MethodsThis protocol describes a feasibility trial to Group PM+ in Sindhuli, Nepal. This study will evaluate procedures for a cluster randomized controlled trial (c-RCT) with Village Development Committees (VDCs), which are the second smallest unit of government administration, as the unit of randomization. Adults with high levels of psychological distress and functional impairment will receive either Group PM+ (n = 60) or enhanced usual care (EUC; n = 60). Psychological distress, functional impairment, depression symptoms, posttraumatic stress disorder (PTSD) symptoms, and perceived problems will be measured during screening, pre-treatment baseline, and 7–10 days after the intervention. Qualitative data will be collected from beneficiaries, their families, local stakeholders, and staff to support quantitative data and to identify themes reporting that those involved and/or effected by Group PM+ perceived it as being acceptable, feasible, and useful. The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention; to identify issues around implementation of local adaptation methods, training, supervision, and outcomes measures; and to assure that procedures are adequate for a subsequent effectiveness c-RCT.DiscussionOutcomes from this trial will contribute to optimizing feasibility and acceptability through cultural adaptation and contextualization of the intervention as well as refining the design for a c-RCT, which will evaluate the effectiveness of Group PM+ in Nepal.Trial registrationClinicalTrials.gov identifier: NCT03359486
DOI：
10.1146/annurev-clinpsy-032816-045217
发表时间：
2017-05-08
影响因子：
18.4
作者：
Singla DR;Kohrt BA;Murray LK;Anand A;Chorpita BF;Patel V
通讯作者：
Patel V