支持同伴互动以扩大西班牙语患者获得数字认知行为疗法的机会 (SUPERA)
2026年5月15日 更新者：Stephen Matthew Schueller、University of California, Irvine
SUPERA：支持同伴互动以扩大初级保健中讲西班牙语的安全网患者获得数字认知行为疗法的机会
调查人员将评估在初级保健机构中针对患有抑郁症和/或焦虑症的拉丁裔患者实施基于证据的西班牙语数字认知行为治疗干预 (SilverCloud) 的情况。
426 名参与者将参加一项双臂试验，比较自我指导与支持的 dCBT (SilverCloud)。
在提供者层面，研究人员将比较提供者转诊与使用诊所患者登记的效果，以确定可以从数字心理健康干预中受益的候选人。
研究概览
详细说明
研究人员将评估基于证据的西班牙语数字认知行为疗法 (dCBT) 干预 (SilverCloud) 在安全网初级保健诊所中针对英语水平有限 (LEP) 患有抑郁症和/或焦虑症的拉丁裔患者的实施情况。
将进行具有提供者和患者水平随机化的有效性实施混合试验（类型 2）设计。
在提供者层面，研究人员将比较外展（使用诊所患者登记处）和接触（传统提供者转诊），在患者层面，将比较 dCBT 平台的两种交付模式——支持和不支持。
研究类型
介入性
注册 (估计的)
426
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
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Arizona
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Payson、Arizona、美国、85541
- Payson Christian Clinic
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Tucson、Arizona、美国、85711
- Family and Community Medicine Mobile Health Clinic
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California
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Berkeley、California、美国、94720
- University of California
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Irvine、California、美国、92697
- University of California
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San Francisco、California、美国、94110
- Zuckerberg San Francisco General
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San Francisco、California、美国、94114
- Castro-Mission Health Center
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San Francisco、California、美国、94134
- Silver Avenue Family Health Center
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New Mexico
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Albuquerque、New Mexico、美国、87017
- UNMH North Valley Clinic
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Albuquerque、New Mexico、美国、87102
- Truman Health Clinic
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Albuquerque、New Mexico、美国、87108
- UNM Southeast Heights Clinic
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Rio Rancho、New Mexico、美国、87144
- Sandoval Regional Medical Center
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- PHQ-9 ≥ 10 或 GAD-7 ≥ 8
- 可以在家中通过智能手机和/或宽带上网，具有基本的技术素养或愿意接受简短的技术使用培训
- ≥18岁
- 偏好在西班牙语中接受医疗
- 不在同步心理治疗中
- 如果目前正在服用抗抑郁药，患者必须已经服用稳定剂量至少 6 周，并且没有改变剂量的计划。 我们将允许服用抗抑郁药的患者进入研究，因为这将提高普遍性。 如有必要，将在每次评估时监测抗抑郁状态，以控制这些影响。
排除标准：
- 目前正在接受心理治疗，因为这种治疗将作为抑郁症和焦虑症的一线治疗提供，但是，允许患者在参与这项研究时接受治疗，并且将在分析中监测和考虑治疗的开始
- 会妨碍完成研究程序的视觉、听觉、声音或运动障碍或文盲
- 精神障碍、双相情感障碍、解离障碍或物质使用障碍的诊断
- 严重的自杀倾向（通过表达自杀意念、计划和意图来评估）。 尽管针对出现自杀倾向的患者制定了具有后备计划的程序（参见人类受试者部分），但评估为严重自杀倾向的患者将被转诊至更密集的治疗资源。
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 |
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实验性的：治疗
随机分配到这种情况的参与者将获得 SilverCloud 平台的所有功能，并被分配一名提供定期支持的同行支持者。
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在受支持的 dCBT 条件下，每位患者都将获得对 SilverCloud 平台的完整访问权限。
此外，患者将被分配一名支持者，该支持者将根据既定的辅导支持协议提供定期支持。
支持者将进行简短的参与电话会议（30-40 分钟），以提供 SilverCloud 的概述、确定目标、设定期望、自我介绍，并让参与者了解同行支持者的角色。
然后，支持者将通过电话或短信提供每周签到。
参与者将能够通过该平台通过消息传递或共享活动与支持者进行交流以进行额外讨论。
支持的主要目标是促进平台的使用。
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有源比较器：控制
随机分配到此条件的参与者将获得 SilverCloud 平台的所有功能，但同行支持者除外。
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不受支持的 dCBT 提供 SilverCloud 平台的所有功能，但支持功能除外（与支持者的结构化交互和共享功能）。
将为患者提供对 SilverCloud 的完全访问权限，并指导其使用 8 周。
患者将每周收到自动消息以鼓励参与。
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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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8 周时抑郁症的变化
大体时间：从基线到第 8 周的变化
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抑郁症状的主要结果将通过自我报告的患者健康问卷 9 (PHQ-9) 来衡量。
PHQ-9 是一个包含 9 项的自我报告抑郁症测量方法。
该指标的得分范围从 0（完全没有）到 3（几乎每天）。
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从基线到第 8 周的变化
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8 周时焦虑的变化
大体时间：从基线到第 8 周的变化
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抑郁症状的主要结果将通过自我报告的一般性焦虑症 7 (GAD-7) 来衡量。
GAD-7 是一种 7 项自我报告的焦虑测量方法。
该指标的得分范围从 0（完全没有）到 3（几乎每天）。
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从基线到第 8 周的变化
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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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平台使用
大体时间：从基线到第 8 周的平台总使用情况
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平台使用将被定义为在平台上花费的时间。
平台使用时间将从 0 分钟到任何参与者在平台上花费的最高分钟数不等。
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从基线到第 8 周的平台总使用情况
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8 周时功能变化
大体时间：从基线到第 8 周的变化
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功能将根据世界卫生组织残疾评估表（WHODAS）进行评估，这是一项包含 36 项自我报告的措施，评估六个领域的残疾，包括理解和沟通、出行、自我护理、与人相处、生活活动（即家庭、工作和/或学校活动）以及社会参与。
该指标的得分范围为 1（无）到 5（非常）。
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从基线到第 8 周的变化
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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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8 周时应用基于 CBT 的技能的频率变化
大体时间：从基线到第 8 周的变化
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行动和思想频率量表 (FATS)。
一项包含 12 项的措施，将用于评估参与者应用基于 CBT 的技能的频率。
较高的分数意味着受访者应用他们所学的基于 CBT 的技能的频率较高。
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从基线到第 8 周的变化
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8 周时 CBT 知识的变化
大体时间：从基线到第 8 周的变化
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CBT 知识获取。
一项包含 16 项的调查，将用于评估 CBT 治疗知识的变化。
分数越高意味着受访者对 CBT 技能的了解程度越高。
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从基线到第 8 周的变化
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心理健康的变化
大体时间：从基线到第 8 周的变化
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心理健康将通过繁荣简要清单 (BIT) 进行评估，这是一项包含 10 项的自我报告措施。
该指标的得分范围为 5（低水平繁荣）到 50（高水平繁荣）。
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从基线到第 8 周的变化
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8 周时的压力变化
大体时间：从基线到第 8 周的变化
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压力将通过感知压力量表 (PSS-4) 进行评估，这是一种包含 4 项的自我报告测量方法，用于评估人们正在经历的与其压力经历相关的感受和想法。
该指标的得分范围为 0（无感知压力）到 16（高感知压力）。
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从基线到第 8 周的变化
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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：Adrian Aguilera, PhD、University of California, Berkeley
- 首席研究员：Stephen M Schueller, PhD、University of California, Irvine
出版物和有用的链接
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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14日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年3月31日
研究注册日期
首次提交
2023年2月16日
首先提交符合 QC 标准的
2023年2月16日
首次发布 (实际的)
2023年2月28日
研究记录更新
最后更新发布 (实际的)
2026年5月19日
上次提交的符合 QC 标准的更新
2026年5月15日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 1856
- R01MH126664 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
个人参与者数据将存放在 NIH 数据存储库 NIMH 数据档案中
IPD 共享时间框架
描述性数据将每六个月提交一次。
研究结果的分析数据集将尽快存放在存储库中，但不得迟于项目完成后一年内。
数据可用性没有结束日期。
IPD 共享访问标准
任何希望访问数据并遵守 NIMH 数据存档政策的人。
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
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