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Effectiveness of Group Focused Psychosocial Support for Adults Affected by Humanitarian Crises (GroupPM+)

2020年10月12日 更新者:Brandon A Kohrt, MD, PhD、George Washington University

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

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+).

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

611

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Morang
      • Biratnagar、Morang、尼泊尔
        • Transcultural Psychosocial Organization (TPO) Nepal

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Group problem management plus
Five sessions of group low intensity psychological intervention
Low intensity group psychological intervention including stress management, behavioral activation, problem solving, and strengthening social support
有源比较器:Enhanced treatment as usual
Referral to primary health care workers trained in mental health Gap Action Programme.
Referral to primary care workers trained in mental health Gap Action Program Implementation Guide
其他名称:
  • mental health Gap Action Program-Implementation Guide

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
General psychological distress - General Health Questionnaire
大体时间:20-weeks after baseline
12-item measure of general psychological distress, validated in Nepal
20-weeks after baseline

次要结果测量

结果测量
措施说明
大体时间
Daily functioning - World Health Organization Disability Assessment Scale
大体时间:20-weeks after baseline
12-item assessment ability to engage in daily activities, previously used in numerous studies in Nepal
20-weeks after baseline
Depression - Patient Health Questionnaire
大体时间:20-weeks after baseline
9-item measure of depression symptoms, culturally and clinically validated in Nepal
20-weeks after baseline
Posttraumatic Stress Disorder - Posttraumatic Stress Disorder Checklist
大体时间:20-weeks after baseline
8-tem measure of post-traumatic stress symptoms validated for use in Nepal
20-weeks after baseline
Cultural idiom of psychological distress - Heart-Mind Screener
大体时间:20-weeks after baseline
2-item locally develop psychological distress screener
20-weeks after baseline
Perceptions of support from family, friends, and others - Multidimensional Scale of Perceived Social Support
大体时间:20-weeks after baseline
12-item assessment of perceptions of support from 3 sources: Family, Friends, and a Significant Other
20-weeks after baseline
Somatic symptom burden - Somatic Symptom Scale
大体时间:20-weeks after baseline
8-item brief measure of somatic symptom burden
20-weeks after baseline

其他结果措施

结果测量
措施说明
大体时间
Reducing Tension Checklist for Problem Management Plus Skills
大体时间:20-weeks after baseline
10-item measure of behavioral and psychosocial skills related to coping mechanisms
20-weeks after baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Mark van Ommeren, PhD、World Health Organization

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年11月25日

初级完成 (实际的)

2019年9月30日

研究完成 (实际的)

2019年9月30日

研究注册日期

首次提交

2018年10月31日

首先提交符合 QC 标准的

2018年11月17日

首次发布 (实际的)

2018年11月20日

研究记录更新

最后更新发布 (实际的)

2020年10月14日

上次提交的符合 QC 标准的更新

2020年10月12日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

This will be shared for full trial.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Group problem management plus的临床试验

3
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