解决夜间睡眠/觉醒对老年人自杀风险的影响 (ANSWERS-OA)
解决夜间睡眠/觉醒对老年人自杀风险的影响 (ANSWERS-OA):失眠数字认知行为疗法的试点、开放标签、随机对照试验
研究概览
详细说明
该试点试验的主要目标是确定在患有失眠和自杀意念的老年人中实施 dCBT-I 的可行性和初步安全性。 次要目标包括估计 dCBT-I 对该人群失眠和自杀意念的潜在疗效和持久性,以及评估神经认知功能作为治疗反应的中介/调节者。 为实现这一目标,将招募 65 岁及以上患有失眠和近期自杀意念的个人进行 12 周治疗 (dCBT-I) 或候补名单控制 (WLC)。 dCBT-I 完成后,WLC 中的个人将交叉到 dCBT-I(WLC + dCBT-I)。 所有参与者将在治疗后 6 个月和 12 个月时接受重新评估。
该项目的主要目标如下:
目标 1:评估 dCBT-I 是否是针对失眠和自杀意念的老年人的可行干预措施。 这将通过受试者参与和遵守 dCBT-I、评估获得治疗的技术或认知障碍以及招募和辍学结果来评估。
目标 2:调查 dCBT-I 对有自杀意念的老年人是否安全。 这将通过比较治疗后失眠、抑郁、焦虑和认知结果以及 dCBT-I 和 WLC 之间的自发不良事件报告,以及治疗后对副作用评定量表-患者自我报告(SERS-拍)形式。
该项目的次要目标如下:
目标 3:探索 dCBT-I 是否可以减少老年人的自杀意念。 虽然研究人员预计 dCBT-I 将减少失眠老年人的自杀意念,但收集初步数据以估计效应量将使我们能够为未来的研究提供适当的动力。 自杀意念将使用哥伦比亚自杀严重程度评定量表 (CSSRS) 在治疗前/后进行测量,并在整个治疗过程中每周使用自杀意念严重程度的自我报告等级进行测量。 比较将是 dCBT-I 与 WLC(组间)和 WLC 与 WLC + dCBT-I(组内),使用线性混合效应或广义估计方程模型。
目标 4:评估 dCBT-I 治疗对老年人自杀意念的持久性。 根据 6 个月和 12 个月的随访评估,研究人员将评估老年人 dCBT-I 后自杀意念持续改善的潜在持续时间,以及这与同时睡眠连续性和质量的关系。
目标 5:调查 dCBT-I 期间睡眠和自杀意念的变化是否与神经认知的变化有关。 神经认知功能将使用基于网络的神经心理学评估 NeuroCognitive Performance Test 在治疗前后进行正式评估。 此外,将使用作为同一系统的一部分实施的颜色匹配任务对反应抑制进行每周评估。
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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Arizona
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Tucson、Arizona、美国、85711
- Banner Whole Health Clinic
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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:
- 65 岁及以上的个人
- 英语会话
- 男女不限
- 当前失眠(基线期间失眠严重程度指数得分≥8)。
- 最近的自杀意念(在过去一个月内认可哥伦比亚自杀严重程度评定量表的第 1 或 2 项 - 自杀意念子量表)。
- 所有参与者都必须同意在研究团队和他们的治疗提供者(他们的处方精神科医生、他们的硕士级非实习治疗师或他们的博士级心理学家)之间发布信息。
排除标准:
- 双相情感障碍、任何精神病或其他被视为 dCBT-I 禁忌症的严重精神疾病的诊断。
- 如果受试者正在服用精神药物(例如,抗抑郁药、安眠药),他们在过去 6 周内不应改变剂量,并且应同意在试验期间不改变剂量。
- 如果受试者没有服用精神药物,他们应该至少 6 周不服用药物,并且应该同意在试验期间不开始新的药物治疗。
- 怀疑或证据表明存在未经治疗的睡眠呼吸暂停、不宁腿综合征或其他需要医生治疗的未经治疗的睡眠障碍。
- 不受控制或不稳定的慢性疾病
- 通过记录审查和入学面谈确定的预期寿命少于 1 年。
- 认知障碍足以损害 dCBT-I 的传递或保留,如 Short Blessed 测试所示。
- 目前正在或正在计划上夜班/夜班。
- 无法访问互联网或进行数字治疗所需的技术。
- 因自杀未遂或严重自杀意念而住院的参与者,或者在过去 3 个月内认可任何自杀意图的参与者,除了提供研究信息发布外,还必须获得其治疗提供者的同意/批准才能参与团队与治疗团队进行沟通。
学习计划
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:交叉作业
- 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:失眠的数字认知行为疗法
在进行基线评估后,该组的参与者将接受为期 8 周的失眠数字认知行为疗法,该疗法使用互联网实现睡眠健康 (SHUTi)。
中期评估后,参与者将交叉进行 8 周的主动监测。
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失眠症数字认知行为疗法是一种基于互联网的自动化交付系统,是失眠症认知行为疗法 (CBT-I) 的核心组成部分。
对于此试验,dCBT-I 将使用“使用互联网的睡眠健康”(SHUTi) 提供,它在 6 个名为“核心:准备好”的互动课程中提供 CBT-I 的核心内容;睡眠安排;睡眠习惯;思维方式不同;睡眠卫生;继续前进。
通过这些核心部署的主要治疗方法是刺激控制和睡眠限制。
本研究的最低可接受剂量是完成 6 个核心中的 4 个;完成少于 4 个核心将被视为辍学。
其他名称:
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无干预:候补名单控制
在基线评估之后,该组的参与者将每周监测一次失眠和自杀意念,持续 8 周。
参与者将继续他们目前接受的任何治疗,但不会接受针对失眠的具体指导或行为干预。
中期评估后,参与者将交叉接受失眠的数字认知行为疗法。
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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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目标 1a:评估 dCBT-I 对于患有失眠和自杀意念的老年人是否是一种可行的干预措施。
大体时间:最长 24 周。
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子目标 1a:确定参与者对 10 周 dCBT-I 的参与度。
指标:完成 10 周治疗期的入组受试者百分比
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最长 24 周。
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目标 1b:评估 dCBT-I 对于患有失眠和自杀意念的老年人是否是一种可行的干预措施。
大体时间:最长 24 周。
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子目标 1b:衡量参与者对 dCBT-I 治疗的依从性。
指标:完成 6 个治疗模块中的 4 个的受试者百分比。
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最长 24 周。
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目标 2:调查 dCBT-I 对于有自杀意念的老年人是否安全。
大体时间:最长 24 周。
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指标:通过副作用评定量表 - 患者自我报告 (SERS-Pat) 表格测量的自我报告副作用的频率。
SERS-Pat 通过询问其发生频率(“完全没有”、“比平常多一点”、“比平常多”、“比平常多得多”来评估 11 种常见副作用(患者可以选择列出其他副作用) ”)以及他们与治疗的感知关系(“完全不相关”、“可能相关”、“可能相关”)。
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最长 24 周。
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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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目标 3:探索 dCBT-I 是否可以减少老年人的自杀意念。
大体时间:通过学习完成,平均1年。
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测量哥伦比亚自杀严重程度量表 (CSSRS) 分数相对于基线的变化。
CSSRS 衡量一个人一生中、前 3 个月以及自上次访问/访谈以来自杀想法和行为的存在及其严重程度。
问题要么是/否,要么大致范围为 0-5,分数越高反映症状越严重。
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通过学习完成,平均1年。
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合作者和调查者
调查人员
- 首席研究员:Michael A Grandner, PhD、University of Arizona
出版物和有用的链接
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