优化骨科护理中的心理健康
骨科护理中心理健康干预的优化实施
研究概览
详细说明
抑郁和焦虑会加剧肌肉骨骼疼痛,并对骨科手术后的结果产生负面影响。 这种现象在老年人中尤为普遍。 我们正在进行的试点工作表明,已建立的数字心理健康干预 (Wysa) 有望改善骨科患者的心理健康症状,但我们也遇到了与在骨科环境中讨论心理健康相关的实施障碍。 这一系列研究的长期目标是提供真正的综合护理,以改善骨科患者的身心健康。 该项目的目标是解决我们在正在进行的试点工作中遇到的实施障碍,并为最终试验做准备,以评估数字心理健康干预在骨科护理方面的有效性。
具体目标是:1.) 确定实施成功的背景决定因素,以在骨科护理的背景下解决患者的心理健康问题; 2.) 对可以在现实骨科环境中实施的两种心理健康干预措施进行可用性测试:数字心理健康干预措施 (Wysa) 和新颖的印刷资源指南; 3.) 确定数字心理健康干预 (Wysa) 改善骨科患者心理健康症状的中间机制。
使用标准定性方法并在实施研究综合框架 (CFIR) 和行为改变 COM-B 模型的指导下,将采访两个利益相关者群体:骨科提供者和老年骨科脊柱患者。 除了解决与讨论骨科护理环境中的心理健康相关的特定需求和偏好外,患者利益相关者还将完成 Wysa 以及本地和在线心理健康资源的新颖印刷指南的可用性测试。 接下来,患者利益相关者将获得一个月的 Wysa 访问权限。 他们将在基线和一个月的随访中完成临床有效性(自我报告的抑郁、焦虑、疼痛干扰、身体功能)和假设的行为目标(行为激活、疼痛接受、睡眠质量)的测量。 研究结果将促进后续临床有效性试验的设计,该试验旨在在骨科护理的背景下公平传播和有效实施心理健康干预。
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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Missouri
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St Louis、Missouri、美国、63110
- Washington University School of Medicine
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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
描述
纳入标准:
- 骨科患者因颈部和/或背部疼痛向脊柱专家进行门诊评估
- 肌肉骨骼脊柱疼痛 3 个月以上
排除标准:
- 例行术后复诊,无进一步手术计划
- 支持心理健康危机(主动自杀或杀人意念、精神病)
- 认知障碍会干扰有意义的研究访谈、问卷调查和/或干预
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 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:脊柱骨科患者
除了参与研究干预措施的半结构化访谈和可用性测试之外,该组的参与者还将获得一个月的 Wysa 访问权限。
他们将在基线和一个月的随访中完成临床有效性和假设行为目标的测量。
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Wysa 是一种数字心理健康干预(即移动应用程序),它使用基于人工智能的聊天机器人和基于文本的对话与硕士水平的人类“教练”辅导员提供认知行为疗法、正念训练和睡眠工具。
在这项研究中,将使用专门为患有慢性疼痛的用户设计的定制版 Wysa。
定制体验包括基于行为激活的附加功能。
该版本目前尚未上市。
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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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成人 PROMIS CAT 抑郁症 v1.0
大体时间:从基线到治疗后的分数变化(第 1 个月)
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PROMIS(患者报告结果测量信息系统)抑郁测量是一种简短的、计算机改编的抑郁症状测量。
它是一个标准化的度量,平均值为 50,标准差为 10。
较高的分数表示抑郁症状增加。
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从基线到治疗后的分数变化(第 1 个月)
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成人 PROMIS CAT Anxiety v1.0
大体时间:从基线到治疗后的分数变化(第 1 个月)
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PROMIS(患者报告结果测量信息系统)焦虑测量是一种简短的、计算机适应的焦虑症状测量。
它是一个标准化的度量,平均值为 50,标准差为 10。
较高的分数表示焦虑症状增加。
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从基线到治疗后的分数变化(第 1 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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成人 PROMIS CAT 疼痛干预 v1.1
大体时间:从基线到治疗后的分数变化(第 1 个月)
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PROMIS(患者报告结果测量信息系统)疼痛干扰测量是一种简短的、计算机改编的测量疼痛对一个人生活的干扰程度。
它是一个标准化的度量,平均值为 50,标准差为 10。
较高的分数表示增加的疼痛干扰。
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从基线到治疗后的分数变化(第 1 个月)
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成人 PROMIS CAT 身体功能 v2.0
大体时间:从基线到治疗后的分数变化(第 1 个月)
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PROMIS(患者报告结果测量信息系统)身体机能测量是一种简短的计算机自适应测量,用于衡量个人自我报告的身体机能。
它是一个标准化的度量,平均值为 50,标准差为 10。
分数越高代表身体机能越好。
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从基线到治疗后的分数变化(第 1 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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抑郁量表的行为激活 - 简表 (BADS-SF)
大体时间:从基线到治疗后的分数变化(第 1 个月)
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BADS-SF 是一项包含九个项目的自我报告行为激活措施(即参与带来愉悦感的活动)。
该度量从 0 到 54 打分,得分越高表示激活程度越高。
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从基线到治疗后的分数变化(第 1 个月)
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慢性疼痛接受问卷 (CPAQ-8)
大体时间:从基线到治疗后的分数变化(第 1 个月)
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CPAQ-8 是一个包含八个项目的自我报告的疼痛接受度测量(即,尽管有疼痛但仍过着生活的思维模式,而不是专注于疼痛的存在)。
该测量值从 0 到 48 分,分数越高代表对疼痛的接受程度越高。
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从基线到治疗后的分数变化(第 1 个月)
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雅典失眠量表 (AIS)
大体时间:从基线到治疗后的分数变化(第 1 个月)
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AIS 是一个包含八个项目的自我报告失眠严重程度的衡量标准。
它评估多个睡眠领域,包括睡眠持续时间、中断、质量以及因睡眠不佳引起的对日常功能的干扰。
该测量值从 0 到 24 分,分数越高代表睡眠困难越大。
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从基线到治疗后的分数变化(第 1 个月)
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系统可用性量表 (SUS)
大体时间:从基线到治疗后的分数变化(第 1 个月)
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SUS 是可用性的简要衡量标准,可适用于数字和印刷干预。
该度量从 0 到 100 打分,分数越高表示可用性越好。
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从基线到治疗后的分数变化(第 1 个月)
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参与内容
大体时间:第 1 个月
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参与内容定义为用户在感兴趣的时间范围内发起的会话数,并且与以下每个类别相关:行为激活、正念和/或睡眠工具。
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第 1 个月
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合作者和调查者
调查人员
- 首席研究员:Abby Cheng, MD、Washington University School of Medicine
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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