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)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •≥10 on Insomnia Severity Index
- •Primary HSCT physician approval
- •English speaking
排除标准
- •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)
结局指标
主要结局
Recruitment
时间窗: 1 year
number of people enrolled out of the number of people eligible
Retention
时间窗: 1 year
number of participants who complete the study
Attendance
时间窗: pre-hematopoietic stem cell transplant (HSCT) reassessment
number of cognitive behavioral therapy for insomnia (CBT-I) sessions attended
次要结局
- Adherence(pre-HSCT reassessment)
- Acceptability of Intervention Measure (AIM)(pre-HSCT reassessment)
- Feasibility of Intervention Measure (FIM)(pre-HSCT reassessment)
- Intervention Appropriateness Measure (IAM)(pre-HSCT reassessment)
- Insomnia Severity Index (ISI)(Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment)
- PROMIS Sleep-Related Impairment Short Form 8a(Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment)
- Actigraph total sleep time(Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment)
- Actigraph sleep efficiency(Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment)
- Actigraph wake after sleep onset(Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment)
- The PROMIS 29+2(Baseline, pre-HSCT reassessment, 1 month post-HSCT reassessment, 3 month post-HSCT reassessment)