ASHA 孟加拉国——解决贫困和抑郁症的综合干预
2026年6月11日 更新者：Alison Karasz、University of Massachusetts, Worcester
ASHA 孟加拉国——解决低收入农村妇女抑郁问题的综合干预措施
这项随机对照试验的目的是比较针对患有抑郁症的孟加拉国低收入农村妇女，将扶贫和抑郁症治疗相结合的综合干预措施与单独治疗抑郁症的效果。
它旨在回答的主要问题是：1）通过抑郁症状和是否复发来评估，在综合干预中将扶贫与抑郁症治疗相结合是否可以改善 24 个月时的抑郁症结局； 2）在抑郁症治疗中加入扶贫是否可以改善实施结果，包括治疗的接受和保留。
两组参与者将在 6、12、18 和 24 个月时参加访谈。
研究概览
研究类型
介入性
注册 (估计的)
600
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。
学习联系方式
- 姓名：Alison Karasz, PhD
- 电话号码：3478435652
- 邮箱：alison.karasz@umassmed.edu
学习地点
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Dhaka Division
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Dhaka、Dhaka Division、孟加拉国
- 招聘中
- International Centre for Diarrhoeal Disease Research
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接触：
- Fahmida Tofail, MBBS, PhD
- 邮箱：ftofail@icddrb.org
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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
- 成人
接受健康志愿者
不
描述
纳入标准：
- 已婚妇女；
- 18-75岁；
- 精通孟加拉语）；
- 符合经济脆弱性指数的标准
- 患者健康问卷（基线时 PHQ-9 抑郁量表）>=10
排除标准：
- 无法提供知情同意；
- 计划在 24 M 期间旅行 > 1 个月。
- 因任何其他原因无法参加研究
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：抑郁症治疗（DT）
对照组参与者将接受：1）6次手册化团体心理治疗。该治疗改编自世界卫生组织名为“问题管理加强版”（PM+）的项目。PM+包含4种循证策略：问题解决；增加社会支持；行为激活；以及通过深呼吸放松；2）4次支持小组会议。干预由经过培训的非专业同伴实施。
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对照组参与者将接受为期6个月、共10次的手册化团体心理治疗。
该治疗方案改编自世界卫生组织名为“问题管理增强版”（PM+）的项目。
PM+包含4种循证策略：1）问题解决；2）增强社会支持；3）行为激活；以及4）通过深呼吸实现放松。
干预措施由经过培训的非专业同伴提供。
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实验性的：综合干预
实验组包含2个要素：
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对照组参与者将接受为期6个月、共10次的手册化团体心理治疗。
该治疗方案改编自世界卫生组织名为“问题管理增强版”（PM+）的项目。
PM+包含4种循证策略：1）问题解决；2）增强社会支持；3）行为激活；以及4）通过深呼吸实现放松。
干预措施由经过培训的非专业同伴提供。
除上述心理治疗干预外，实验组参与者还将接受一项基于著名的"阶梯计划"（一种在低收入国家广泛使用的扶贫干预措施）调整的扶贫干预。该扶贫干预包括：a) 4节金融知识教育课程；b) 储蓄账户；c) 为期六个月、相当于每日1公斤大米成本的消费支持；d) 3只山羊的生产性资产转移；e) 12个月的动物饲料和兽医护理；f) 园艺用品；g) 农业技能培训。
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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 |
|---|---|---|
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在6个月时改变抑郁症状
大体时间：6个月
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根据患者健康问卷的衡量，症状从基线到基线后6个月的变化，这是一项旨在评估抑郁症状的9项问卷。
最低分数为0；最高分数为27。
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6个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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18个月复发
大体时间：18个月
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复发定义为在时间点2（6个月）时达到缓解的参与者中，患者健康问卷得分≥5分。
为评估复发情况，在每个数据收集点（6、12和18个月），研究者将询问参与者自上次数据收集点以来是否出现过抑郁症状。
数据收集将重点关注18个月时的复发情况，或自时间点2以来的任何时间点出现的复发。
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18个月
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12个月和18个月时的抑郁情况
大体时间：12个月和18个月
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其他时间点的PHQ-9与基线变化：12个月和18个月
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12个月和18个月
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经济脆弱性指数
大体时间：基线、12个月和18个月
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包含收入、债务和粮食不安全等多种指标的经济脆弱性综合指数。
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基线、12个月和18个月
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焦虑
大体时间：基线、6个月、12个月和18个月
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通过广泛性焦虑障碍量表测量的焦虑症状——这是一份包含七个项目的问卷，评分范围为0-21分。
分数越高表示焦虑程度越严重。 |
基线、6个月、12个月和18个月
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功能
大体时间：基线、6个月、12个月和18个月
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根据世界卫生组织残疾评估表（一个包含12个项目的问卷）测量的功能和残疾情况，该问卷的评分范围为12-60分，分数越高表示残疾程度越严重。
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基线、6个月、12个月和18个月
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生活质量的变化
大体时间：基线、6个月、12个月和18个月
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生活质量测量工具，包含五个维度：行动能力、自我照顾、日常活动、疼痛/不适和焦虑/抑郁，评分范围为0-100分，分数越高表示生活质量越好。
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基线、6个月、12个月和18个月
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张力标度
大体时间：基线、6个月、12个月、18个月
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一种同时测量心理症状和躯体文化症状的问卷：这是一份包含39个条目的工具，采用0-3分计分，最低分为0分，最高分为117分，分数越高表示痛苦水平越高。
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基线、6个月、12个月、18个月
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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实施结果--采纳度
大体时间：基线 + 30 天
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参加≥1次治疗阶段的参与者人数/随机分组的参与者人数。
基于招募和研究记录。
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基线 + 30 天
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实施结果--可行性
大体时间：6个月
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基于研究记录，参加≥70%干预会议（7次会议）的参与者百分比。
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6个月
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实施结果--保真度
大体时间：每个六个月的疗程组至少一次。
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督导员对课程的观察将使用李克特量表进行保真度评估，该量表包括准备情况（0-3分）、引导能力（0-11分）、参与度（0-6分）、时间管理（0-1分）和记录情况（0-1分）。
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每个六个月的疗程组至少一次。
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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。
合作者
调查人员
- 首席研究员：Alison Karasz, PhD、UMass Chan Medical School
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。
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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)
2024年3月1日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2024年2月27日
首先提交符合 QC 标准的
2024年2月27日
首次发布 (实际的)
2024年3月6日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年6月11日
最后验证
2026年6月1日
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与本研究相关的术语
其他研究编号
- STUDY00001114
- 7R01MH127577 (美国 NIH 拨款/合同)
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分析完成后，数据将无限期可用
IPD 共享访问标准
从事独立科学研究的合格研究人员可以申请试用 IPD，并将在研究提案和统计分析计划 (SAP) 审查和批准以及数据共享协议 (DSA) 执行后提供。
IPD 共享支持信息类型
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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