Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design
2026年7月22日 更新者：Philip Chow, Ph.D.、University of Virginia
Co-occurring symptoms of insomnia and depression is very common in breast cancer survivors, and it is critical that scalable and easily accessible digital behavioral interventions are made available.
Digital health interventions are scalable and accessible.
Moreover, behavioral digital interventions have been shown to be effective in reducing symptoms of insomnia and depression, respectively, in breast cancer survivors, suggesting strong potential for public impact, though their potential for addressing co-occurring symptoms of insomnia/depression has not been tested.
The purpose of this study is to evaluate the efficacy of a digital insomnia program and a digital mental health program in multiple ways: 1) as standalone interventions to reduce both symptoms of co-occurring insomnia and depression for breast cancer survivors; and 2) as components in adaptive behavioral treatment strategies that optimally sequence them for survivors who need additional support, resulting in a multifaceted supportive approach that is low cost, easily accessible, and highly efficient.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
747
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：Philip Chow, PhD
- 电话号码：434-924-8082
- 邮箱：pic2u@virginia.edu
学习地点
-
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Virginia
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Charlottesville、Virginia、美国、22903
- University of Virginia
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接触：
- Philip Chow, PhD
- 电话号码：434-924-8082
- 邮箱：pic2u@virginia.edu
-
接触：
-
首席研究员：
- Philip Chow, PhD
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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
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- (1) age ≥18 years
- (2) Diagnosed with stage 0-3 breast cancer
- (3) Primary treatment for cancer (i.e., chemotherapy, immunotherapy, radiation, and surgical procedures intended to remove malignant tissue) finished between 3 months to 5 years from enrollment, with the exception of adjuvant hormonal, endocrine, and immunotherapy
- (4) elevated insomnia severity as measured by the Insomnia Severity Index (ISI) score ≥ 10, and elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10
- (5) meets DSM 5 criteria for insomnia and depression.
Exclusion Criteria:
- (1) Current behavioral or psychological treatment for insomnia or depression
- (2) a change in medication for insomnia or depression within the past 4 weeks
- (3) irregular sleep schedules or shift work (i.e., usual bedtimes outside 8:00 p.m.-2:00 a.m. or arising time outside 4:00 a.m.-10:00 a.m.)
- (4) mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care (as indicated from the Pitt-Optimum Suicide Management Protocol)
- (5) other self-reported untreated sleep disorders (i.e., obstructive sleep apnea, restless legs syndrome)
- (6) no reliable internet access (e.g., home broadband, public network, personal data plan) by smartphone
- (7) cannot read and speak English
- (8) does not reside within the US.
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：阶乘赋值
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Digital Insomnia Program First
Participants assigned to receive the digital insomnia program first will use it for 9 weeks.
Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital mental health program) or not.
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A self-guided, fully automated, interactive, and tailored internet-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention).
It is fully accessible as a web-based application via smartphones, computers, and tablets.
Content is metered out over time through six "Cores".
Each Core acts as a digital analog for the typical weekly sessions of face-to-face CBT for insomnia, following the same general structure: (1) Core objectives - what will be learned and why this information is important, (2) review of previous week's homework and sleep diary data, (3) new intervention material, (4) assignment of homework - treatment strategies for the coming week, and (5) a summary of the Core's main points.
Users obtain access to a new Core based on a time- and event-based schedule (i.e., time since previous Core, completion of sleep diaries).
A self-guided, fully automated app designed for brief, frequent check-ins to promote skill acquisition.
Exercises in the app are assigned for 1 week each, and each exercise focuses on a specific mental health target (e.g., cognitive restructuring, savoring positive experiences, increasing knowledge of mental health).
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实验性的：Digital Mental Health Program First
Participants assigned to receive the digital mental health program first will use it for 9 weeks.
Based on their response after 9 weeks, some will be re-randomized to receive an additional intervention (digital insomnia program) or not.
|
A self-guided, fully automated, interactive, and tailored internet-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention).
It is fully accessible as a web-based application via smartphones, computers, and tablets.
Content is metered out over time through six "Cores".
Each Core acts as a digital analog for the typical weekly sessions of face-to-face CBT for insomnia, following the same general structure: (1) Core objectives - what will be learned and why this information is important, (2) review of previous week's homework and sleep diary data, (3) new intervention material, (4) assignment of homework - treatment strategies for the coming week, and (5) a summary of the Core's main points.
Users obtain access to a new Core based on a time- and event-based schedule (i.e., time since previous Core, completion of sleep diaries).
A self-guided, fully automated app designed for brief, frequent check-ins to promote skill acquisition.
Exercises in the app are assigned for 1 week each, and each exercise focuses on a specific mental health target (e.g., cognitive restructuring, savoring positive experiences, increasing knowledge of mental health).
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有源比较器：Psychoeducation Only
Participants assigned to this arm will only receive the psychoeducation program for 9 weeks.
They will not be eligible to be re-randomized to receive additional program.
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An internet delivered program that includes modules containing general health information that is not specific to mental health or insomnia.
Modules contain information on the topics such as exercise and heart health,.
Content is primarily text-based and contains public domain health information; that is, content that is sourced primarily from US government health websites and is non-proprietary.
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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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Patient Health-Questionnaire-8 (PHQ-8)
大体时间：Baseline
|
8 item measure to evaluate severity of depression symptoms.
Each item is evaluated on a scale from 0-3.
Scores range from 0-24, with higher scores indicating greater severity of symptoms of depression.
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Baseline
|
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Patient Health Questionnaire-8 (PHQ-8)
大体时间：Post 18-weeks
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8 item measure to evaluate severity of depression symptoms.
Each item is evaluated on a scale from 0-3.
Scores range from 0-24, with higher scores indicating greater severity of symptoms of depression.
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Post 18-weeks
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Insomnia Severity Index (ISI)
大体时间：Baseline
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7 item measure to evaluate severity of insomnia symptoms.
Each item is evaluated on a scale from 0-4.
Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.
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Baseline
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Insomnia Severity Index (ISI)
大体时间：Post 18-weeks
|
7 item measure to evaluate severity of insomnia symptoms.
Each item is evaluated on a scale from 0-4.
Scores range from 0-28, with higher scores indicating greater severity of insomnia symptoms.
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Post 18-weeks
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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。
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 (估计的)
2026年9月30日
初级完成 (估计的)
2029年8月1日
研究完成 (估计的)
2029年8月30日
研究注册日期
首次提交
2026年7月17日
首先提交符合 QC 标准的
2026年7月17日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年7月22日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 7466
- R01CA295673 (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)？
未定
IPD 计划说明
Contingent on the approval of the University of Virginia
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.