Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Post-session assessment completion
研究概览
简要总结
The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Cognitive Behavior Therapy for Insomnia (CBT-I) in primary brain tumor patients. Researchers hope to better understand the feasibility and acceptability of this intervention in neuro-oncology, as well as the preliminary potential benefits of this intervention on brain tumor patients' sleep, fatigue, mood, quality of life, and chronic inflammation. This may lead to improvements in treating insomnia in primary brain tumor patients.
详细描述
The present study design is a pilot within-subjects pre-/post-evaluation of feasibility, acceptability, and preliminary efficacy of the Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention for primary brain tumor patients. In this study, participants will be asked to do the following things:
- Meet with a trained interventionist six times (biweekly) for group CBT-I sessions via Zoom, lasting 90 minutes each. Participants will be asked to only use first names and will complete weekly sleep diaries as part of the intervention.
- Complete ~20-minute online surveys before the program, immediately after the program (6 weeks), and at follow-up (3 months). Questions will ask about subjective sleep, fatigue, mood, and quality of life. The follow-up time point will also ask about the patient's satisfaction with the CBT-I program.
- Complete a brief (15 minute) cognitive evaluation before and immediately following the program.
- Wear a wrist-worn actigraphy monitor one week prior to the 6-week CBT-I intervention and one week following completion of the intervention.
- Patients currently receiving regular blood draws as part of their care at Massey Cancer Center will have an IL-6 added to their regular blood draw. THose who are not receiving regular blood draws as part of their standard of care OR those who are not patients at Massey Cancer Center will forego this part of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Confirmed primary brain tumor diagnosis
- •>/= 1 month removed from radiation therapy (if applicable)
- •Able to readily read and understand English
- •Meeting DSM-V diagnostic criteria for insomnia as measured by the Structured Clinical Interview for DSM-5
- •Sleep Disorders (SCISD) insomnia subsection
- •Cognitively intact as measured by a score >20 on the Telephone Interview for Cognitive Status (TICS)
- •Have a stable internet connection and video-capable device for Zoom sessions
排除标准
- •Inability to attend weekly group in-person meetings
- •Patients must also meet the inclusion criteria listed above.
结局指标
主要结局
Post-session assessment completion
时间窗: 2 months
Percent of post-session surveys completed by participants immediately after the intervention
Follow-up assessment completion
时间窗: 5 months
Percent of follow-up surveys completed by participants three months after the intervention
Program Satisfaction as measured by participant responses to researcher-developed questions (e.g., How satisfied were you with the program overall?) measured on a Likert scale
时间窗: 7 months
Program satisfaction questions are measured on a 10-point Likert scale with 1 being not at all satisfied and 10 being very much satisfied. Higher scores indicate greater program satisfaction.
Feasibility for CBT-I as measured by the rates of participant screening, eligibility, and consent
时间窗: 12 months
Determine how many patients consent to screening after referral to the program, how many patients are eligible for the program after being screened, and how many consent/enroll in the program if eligible.
Attendance at CBT-I sessions
时间窗: 6 weeks
Percent of sessions attended by consented participants
次要结局
- Executive Function(7 months)
- Primary Brain Tumor Characteristics(7 months)
- Sleep Efficiency(7 months)
- Objective Sleep(7 months)
- Subjective Sleep(7 months)
- Subjective Sleep Disturbance(7 Months)
- Napping(7 Months)
- Fatigue(7 Months)
- Death Anxiety(7 Months)
- Subjective Insomnia(7 Months)
- Subjective Quality of Life as measured by participants' responses on the European Organization Research and Treatment of Cancer - Quality of Life - Cancer 30 (EORTC-QoL-C30) form.(7 Months)
- Inflammation(7 Months)
- Learning/Memory(7 months)
- Sociodemographics(7 months)
- Depression(7 Months)
- Anxiety(7 Months)
- Processing Speed(7 months)
- Language Fluency(7 months)