Early Cognitive Behavioral Therapy for Insomnia (CBT-I) in People Planning to Under Hematopoietic Stem Cell Transplant (HSCT)
2026年8月14日 更新者：University of Kansas Medical Center
Feasibility, Acceptability, and Preliminary Treatment Efficacy of Early Cognitive Behavioral Therapy for Insomnia (CBT-I) to Mitigate Insomnia Symptoms and Fatigue and Improve Health-related Quality of Life in Individuals Planning to Undergo Hematopoietic Stem Cell Transplant (HSCT)
This proposed study is a prospective, randomized, controlled Phase 1 clinical trial to determine feasibility, acceptability (Aim 1) and preliminary effect (Aim 2) to mitigate insomnia symptoms and fatigue and improve health-related quality of life in patients who are planning to undergo HSCT.
The investigators plan to enroll n=30 with insomnia symptoms (Insomnia Severity Index ≥10) who will be randomized into one of two groups: 1.
A group that starts CBT-I after the initial evaluation visit with the HSCT care team (Early CBT-I), or 2. Treatment as usual (TAU).
Participants in the CBT-I group will receive six sessions of telehealth-delivered CBT-I that is completed prior to transplant.
Reassessments will occur post-intervention (~1-2 weeks before HSCT) and 1- and 3-months post-HSCT.
研究概览
研究类型
介入性
注册 (估计的)
30
阶段
- 阶段1
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：Catherine Siengsukon, PT, PHD
- 电话号码：913-588-6913
- 邮箱：csiengsukon@kumc.edu
研究联系人备份
- 姓名：Jade Robichaud
- 邮箱：jrobichaud@kumc.edu
学习地点
-
-
Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
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接触：
- Jade Robichaud
- 邮箱：jrobichaud@kumc.edu
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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:
- ≥18 years old
- ≥10 on Insomnia Severity Index
- Primary HSCT physician approval
- English speaking
Exclusion Criteria:
- Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
- >3 on STOP BANG indicating increased risk of sleep apnea
- Increased risk of Restless legs syndrome as determined by RLS-Diagnosis Index
- Parasomnia as determined by the Sleep Disorders-Revised
- If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking < 3 months or dose has changed in past 3 months
- T-score ≥70 on PROMIS 29+2 Anxiety or PROMIS 29+2 Depression domains indicating moderate/severe anxiety or depression
- Current or history (up to 2 years) of substance use disorder involving drugs or alcohol as defined by DSM-5-TR criteria
- History of other nervous system disorder such as stroke or Parkinson's disease
- Severe mental illness such as schizophrenia or bipolar disorder
- Severe neurological or sensory impairments that would interfere significantly with testing
- History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
- Currently receiving a behavioral sleep health intervention or other behavioral health interventions that may impact sleep (such as exercise, mindfulness, CBT)
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：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：失眠认知行为疗法（CBT-I）
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The CBT-I program is a 1x/week, 6-week one-one-one program via video conferencing with trained research personnel.
The program is based on standard CBT-I manuals.
|
|
无干预：Treatment As Usual (TAU)
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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 |
|---|---|---|
|
Recruitment
大体时间：1 year
|
number of people enrolled out of the number of people eligible
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1 year
|
|
Retention
大体时间：1 year
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number of participants who complete the study
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1 year
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Attendance
大体时间：pre-hematopoietic stem cell transplant (HSCT) reassessment
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number of cognitive behavioral therapy for insomnia (CBT-I) sessions attended
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pre-hematopoietic stem cell transplant (HSCT) reassessment
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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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Adherence
大体时间：pre-HSCT reassessment
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% days/week performed stimulus control or counter control if unable to sleep within 20 minutes and % nights/week conducted wind-down routine
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pre-HSCT reassessment
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Acceptability of Intervention Measure (AIM)
大体时间：pre-HSCT reassessment
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The AIM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree.
A mean is calculated, and higher score indicates greater acceptability.
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pre-HSCT reassessment
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Feasibility of Intervention Measure (FIM)
大体时间：pre-HSCT reassessment
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The FIM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree.
A mean is calculated, and higher score indicates greater feasibility.
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pre-HSCT reassessment
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Intervention Appropriateness Measure (IAM)
大体时间：pre-HSCT reassessment
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The IAM is a 4-item questionnaire with responses from 1 = completely disagree to 5 = completely agree.
A mean is calculated, and higher score indicates greater appropriateness.
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pre-HSCT reassessment
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Insomnia Severity Index (ISI)
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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The ISI consists of 7 items with score ranging from 0-28.
A higher score indicates higher insomnia severity
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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PROMIS Sleep-Related Impairment Short Form 8a
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Consists of 8 items, which are summed and converted to a T-score.
A higher scores indicates greater sleep-related impairment.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Actigraph total sleep time
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Participants will wear an actigraph on their non-dominant wrist for 7 nights.
Total sleep time will be determined using ActiLife software from time to fall asleep to time to wake up and will be reported in minutes.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Actigraph sleep efficiency
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Participants will wear an actigraph on their non-dominant wrist for 7 nights.
Sleep efficiency will be determined using ActiLife software and calculated as total sleep time divided by time in bed X 100 and will be reported in percent.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Actigraph wake after sleep onset
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Participants will wear an actigraph on their non-dominant wrist for 7 nights.
Wake after sleep onset will be determined using ActiLife software and calculated number of minutes determine be awake during the sleep period and will be reported in percent.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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The PROMIS 29+2
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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31-item self-report measure.
Scores are reported as standardized PROMIS T-scores, with higher scores indicating more of the domain being assessed.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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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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Sleep Self-Efficacy Scale (SESS)
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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SESS is a 9-item self-report questionnaire used to measure sleep self-efficacy.
The respondents indicate confidence in ability to accomplish 9 sleep behaviors on a 5-point Likert scale with 1 = "not confident" at all to 5 = "very confident".
The score ranges from 0 to 45 with a higher score indicating greater sleep self-efficacy.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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PROMIS Cognitive Function 8-item short form
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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8 items, each scored from 1-5.
The raw score is converted to a t-score, with higher scores indicating better perceived cognitive function.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
|
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Positive Affect and Negative Affect Schedule (PANAS)
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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The PANAS is a 20-item self-report questionnaire used to measure positive and negative emotions.
There are two subscales (Positive Affect and Negative Affect) with 10 items each.
The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely".
A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicates greater intensity of negative emotions.
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Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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Dysfunctional Beliefs About Sleep (DBAS)
大体时间：Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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This assessment is a 10 item Likert-scale self-report questionnaire.
Higher scores indicate more dysfunctional beliefs.
|
Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment
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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8日
初级完成 (估计的)
2027年6月30日
研究完成 (估计的)
2027年6月30日
研究注册日期
首次提交
2026年8月11日
首先提交符合 QC 标准的
2026年8月14日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月14日
最后验证
2026年8月1日
更多信息
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.