将短信整合到母婴课程中
将短信整合到母婴课程中以解决低收入女性及其伴侣的抑郁问题
研究概览
详细说明
尽管产后抑郁症对母亲和孩子有公认的负面影响,但大多数努力都针对治疗已经表现出抑郁症的女性,而不是预防。 对治疗的强调忽视了大量具有轻度至中度抑郁症状的女性,她们处于高社会心理风险环境中,有患产后抑郁症的风险。 存在可有效预防围产期妇女抑郁症发作和恶化的干预措施。 特别是,PI 和同事已经证明,母婴课程 (MB) 可以防止抑郁症状恶化和新的重度抑郁发作。
先前的 MB 试验表明,对于那些在假设的干预机制中表现出较小变化并且不太充分参与会话之间的家庭作业完成的女性来说,干预不太成功——这是认知行为疗法 (CBT) 干预措施(如 MB)的核心组成部分。 以前的产后抑郁症预防干预措施(包括 MB)都忽略了对孕妇伴侣的干预,尽管人们越来越认识到父亲抑郁症也会对儿童的社交情感发展产生影响,并且发生在相似的时间范围内。 因此,在其他方面成功的干预中,这些局限性——在改善假设的干预机制方面的成功和父亲的有限参与——可能会降低干预效果。 研究人员假设核心 MB 模块将防止重度抑郁发作和抑郁症状恶化。 研究人员还概念化了 MB 模块与产妇心理健康结果之间的关系将由 MB 内容直接关注的机制来调节。
本研究解决了这些局限性。 研究人员将与 10-12 个主要服务于低收入妇女的家访 (HV) 项目合作。 HV 是这项研究的理想环境,因为他们服务的围产期妇女人数众多,并且将建立在伊利诺伊州与 HV 项目的现有关系之上。 在第 1 阶段,研究人员将招募 108 名孕妇进行随机对照试验 (RCT),其中一半参与者将接受 MB,另一半将接受带有短信增强功能的 MB (MB-TXT)。 MB-TXT 将加强与假设的变化机制相关的关键 MB 技能,促进 MB 个人项目(家庭作业)的完成,并促进个人情绪的自我监控。
目标 1。 确定在三个 HV 项目中执行 MB-TXT 干预方案的可行性和可接受性,以为更大的全功率 RCT 做准备。 使用 Co-I Barrera 已经开发的 MB 短信,我们将收集有关家庭访客坚持按指定时间发送短信的情况、回复短信的客户百分比、客户对短信的理解以及对短信的看法的数据。公用事业。
目标 2. 计算可用于与其他相关数据一起使用的初步效应量,以计算未来全效 RCT 的样本量。
H1。与接受 MB 治疗的女性相比,接受 MB-TXT 治疗的女性抑郁症状会明显减轻。
H2。与专门接受 MB 治疗的女性相比,接受 MB-TXT 治疗的女性将在假设的干预机制方面经历更大的变化,消极认知减少,行为激活增加,社会支持网络的使用和情绪调节。
H3。参加 MB-TXT 的女性将报告个人项目的完成情况。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
在第一个或第二个或第三个三个月参加参与家访计划的 16 岁以上讲英语或西班牙语的女性将有资格参加
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:仅 MB 一对一
母婴一对一。
MB 一对一 -12 会话干预 每个 MB 会话持续 15-20 分钟,并作为定期安排的家访(英语或西班牙语)的一部分提供。
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MB 一对一是一个 12 节的干预,分为五个模块。
介绍性的 2 节课模块建立了与压力、情绪监测以及情绪影响个人内部思想和外部环境的方式相关的关键概念;三个 3 节课模块对应于关键的认知行为要素:愉快的活动、思想和社会支持/与他人的接触; 1 节课的总结回顾内容并确定未来使用 MB 技能的领域。
在整个 MB 中,情绪管理技能通过心理教育活动得到整合,这些活动鼓励参与者了解他们的情绪与他们的活动、思想和与他人的接触之间的联系。
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实验性的:MB 1对1 Plus TEXT
母亲和婴儿加文本。
MB 一对一以及英语和西班牙语的文本增强。
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MB 一对一以及英语和西班牙语的文本增强。
这些文本侧重于:a) 技能强化(例如,一些想法刚刚出现,但我们可以有意识地努力思考积极的想法。);
b) 家庭作业提醒(例如,你今天会尝试什么愉快的活动?),以及 c) 自我监控(例如,在 1-9 的等级上,你如何评价你的心情?)。
这些文本将与 12 MB 的会话链接。
具体来说,在完成每个面对面的会话后,家庭访问者将向她的客户发送 3 条文本;一篇课文将侧重于技能强化,一篇将是作业提醒,一篇将侧重于自我监控。
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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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HV 客户端读取的短信
大体时间:干预后 6 个月
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通过计算客户回复短信的百分比来衡量。
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干预后 6 个月
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家庭访客遵守 MB-TXT 协议
大体时间:干预后 6 个月
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将通过使用 HealthySMS 的存档数据来衡量,以计算在适当时间间隔发送的文本的百分比
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干预后 6 个月
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客户完成个人项目
大体时间:干预后 6 个月
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将通过要求家庭访客在完成每个 MB 会话后回答 REDCap 调查项目来衡量,以评估客户是否已经完成了他们的个人项目。
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干预后 6 个月
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客户感知的效用和对短信的理解
大体时间:干预后 6 个月
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将通过要求家庭访客对会话之间收到的 3 条短信中的每条短信的 a) 有用和 b) 易于理解的程度进行评分来衡量。
问题将采用 4 点李克特量表,并在每次 MB 会议结束时向客户提问。
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干预后 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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抑郁症状
大体时间:6 个月和 9 个月时的基线和干预后
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将使用 Beck 抑郁量表-II (BDI)100 进行评估,该量表包含 21 项抑郁症状的自我报告测量,以评估符合诊断和统计手册 (DSM)-IV 症状标准的抑郁症状的严重程度。
BDI 对门诊样本具有出色的内部信度,其结构效度已得到证实。
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6 个月和 9 个月时的基线和干预后
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认知建构
大体时间:6 个月和 9 个月时的基线和干预后
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将使用经验问卷进行测量,该问卷包含 20 个项目的自我报告量表,用于测量偏心和反刍,这在检验包含认知重构的干预措施效果的研究中显示出很强的内部一致性。
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6 个月和 9 个月时的基线和干预后
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行为激活
大体时间:6 个月和 9 个月时的基线和干预后
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将使用行为激活抑郁量表进行测量,该量表包含 25 个项目、四个分量表,具有很强的心理测量特性。
四个分量表评估激活、回避/反刍、工作/学校障碍和社会障碍。
我们还将使用一个简短的清单,该清单改编自 Pleasant Events Schedule,这是一份心理测量问卷。
这份 25 项自我报告包含与低收入孕妇相关的愉快事件列表,并评估受试者参与这些活动并从中体验快乐的程度。
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6 个月和 9 个月时的基线和干预后
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社会支持
大体时间:6 个月和 9 个月时的基线和干预后
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19 项医疗结果研究社会支持调查。
这项自我管理的调查包括一个总体功能性社会支持指数,以及四个功能性支持分量表:深情、情感/信息、有形和积极的社会互动。
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6 个月和 9 个月时的基线和干预后
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情绪调节
大体时间:6 个月和 9 个月时的基线和干预后
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将使用负面情绪调节量表 (NMRS) 进行测量。NMRS 评估个人对某些行为或认知将减轻负面情绪状态的预期。
对于每个问题,受访者都使用从“非常不同意”到“非常同意”的五分制来表示他们认为在失望或遇到消极情绪时可以做什么。
该量表已证明具有出色的内部一致性、良好的重测信度以及收敛效度和区分效度的相关证据,分别与抑郁症状和控制点等结构相关。
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6 个月和 9 个月时的基线和干预后
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母婴技能运用
大体时间:6 个月和 9 个月时的基线和干预后
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将使用研究调查人员开发的项目进行评估,以评估参与者对在 12 MB 课程中学到的技能的利用情况。
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6 个月和 9 个月时的基线和干预后
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合作者和调查者
出版物和有用的链接
一般刊物
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