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临床试验/NCT03747055
NCT03747055已完成不适用

Effectiveness of Group Focused Psychosocial Support to Improve the Psychosocial Well-being and Functioning of Adults Affected by Humanitarian Crisis in Nepal

George Washington University1 个研究点 分布在 1 个国家目标入组 611 人开始时间: 2018年11月25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
611
试验地点
1
主要终点
General psychological distress - General Health Questionnaire

研究概览

简要总结

This is an effectiveness study of group problem management plus, a low-intensity psychological intervention, delivered in five sessions to adults affected by humanitarian crises. The current study will evaluate the effectiveness of Group Problem Management Plus (PM+).

详细描述

Counselling programmes used in many humanitarian settings are often non- specific with unknown efficacy and safety. Only a few interventions in humanitarian crises have been rigorously tested, and most studied interventions focused on posttraumatic stress disorder. Beyond posttraumatic stress disorder, individuals may have a range of problems including depression, anxiety, and not being able to do daily tasks necessary for survival and recovery. However, interventions are often limited since they tend to target only a single outcome, are usually of longer duration (8-16 sessions) or require professionals.

In low resourced settings interventions need to be short of duration, and be carried out by lay people in the communities to make them sustainable and feasible to implement on a broader scale. World Health Organization aims to develop a range of low-intensity scale-able psychological interventions that address these issues, as part of its mental health Gap Action Program. As a first step a simplified psychological intervention Problem Management Plus (PM+) has been developed. It has 4 core features that make the intervention suitable for low resourced setting exposed to adversities. First, it is brief intervention (5-sessions), delivered individually or in groups; second, it can be delivered by paraprofessionals (high school graduates with no mental health experience), using the principle of task shifting/ task sharing; third, it is designed as a trans- diagnostic intervention, addressing a range of client identified emotional (e.g. depression, anxiety, traumatic stress, general stress) and practical problems; fourth, it is designed for people in low-income country communities affected by any kind of adversity (e.g. violence, disasters), not just focusing on a single kind of adversity. Recent PM+ trails in Pakistan and Kenya have indicated PM+ to be effective in diminishing depression and anxiety and improving people's functioning and self- selected, culturally relevant outcomes. Group PM+ has been piloted in a district in Nepal, which was affected by the 2015 earthquakes. The pilot was conducted to gather information about the feasibility, safety and delivery of the intervention in the Nepali community settings; and to identify issues around training, supervision and outcomes measures. The pilot trial was successful in terms of acceptability and feasibility and detecting possible problems of compliance, delivery of the intervention, recruitment and retention. The current definitive study will evaluate the effectiveness of Group PM+ in Nepal through a pragmatic cluster randomized controlled trial.

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
Double (Participant, Outcomes Assessor)

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

  • score YES to heart-mind problems on heart-mind screener
  • score >16 on World Health Organization Disability Assessment Scale

排除标准

  • Presence of a severe mental disorder (e.g., psychosis)
  • Alcohol use disorder (score >16 on the alcohol use disorders identification test (AUDIT)

结局指标

主要结局

General psychological distress - General Health Questionnaire

时间窗: 20-weeks after baseline

12-item measure of general psychological distress, validated in Nepal

次要结局

  • Somatic symptom burden - Somatic Symptom Scale(20-weeks after baseline)
  • Daily functioning - World Health Organization Disability Assessment Scale(20-weeks after baseline)
  • Depression - Patient Health Questionnaire(20-weeks after baseline)
  • Cultural idiom of psychological distress - Heart-Mind Screener(20-weeks after baseline)
  • Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist(20-weeks after baseline)
  • Perceptions of support from family, friends, and others - Multidimensional Scale of Perceived Social Support(20-weeks after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brandon A Kohrt, MD, PhD

Associate Professor of Psychiatry

George Washington University

研究点 (1)

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