Pilot Study: Developing A Scalable Sleep Health Intervention to Improve Pain, Quality of Life, and Health in Former NFL Players
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b Endpoint
研究概览
简要总结
This pilot study is focused on estimating the impact of a tele-sleep intervention on patient-centered outcomes relevant to former football players, including a) sleep duration, quality, and daytime impairment; b) pain, pain catastrophizing, physical and emotional functioning; c) mood; d) quality of life, with the longer-term goal to evaluate the impact on cardiovascular health risk. The evidence-based 'Brief Behavioral Therapy for Insomnia' (BBTI) will be utilized and tailored it to meet the needs of former football players.
This pilot work will serve as the foundation for a larger, future clinical trial that utilizes a durable approach for improving sleep health with potential influence pain and quality of life as well as future studies to evaluate the implementation and scalability of BBTI in novel populations.
详细描述
The investigators will plan to enroll 40 participants. Players will be recruited from the Harvard Football Players Health Study cohort from across the US via email and telephone invitations. Following screening, if the participant is eligible and interested, they may consent to enroll in the study. Participants will receive evidence-based 'Brief Behavioral Therapy for Insomnia' (BBTI), tailored to meet the needs of former football players. BBTi is a brief, efficacious treatment that focuses on modifying behaviors, rather than cognitive domains. The treatment emphasizes education, motivational tools, and specific behavioral recommendations (e.g., restricting time in bed). BBTI has been previously delivered remotely and this intervention will be delivered by phone by sleep interventionists including trained social workers, psychologists, and nurse practitioners. Participants will complete an intake session with their interventionist followed by a 'treatment session' a week later wherein the interventionist will provide education about sleep regulation and create an individualized schedule of sleep/wake times for the participant. This will be followed by 3 brief weekly check-in calls to review progress, address questions and concerns, and adjust the behavioral treatment plan as the participant progresses. The participant will complete a daily sleep diary throughout the intervention to inform the treatment. Participants will also complete baseline, endpoint and follow-up questionnaires to assess outcomes and intervention acceptability and feasibility. Participants will receive compensation for their participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Able to communicate clearly in English
- •Have a digital device with reliable internet access
- •Sub-clinical insomnia (Insomnia Severity Index, score >7, sub-clinical threshold insomnia)
- •Able to give informed consent
排除标准
- •Prior participation in behavioral therapy for insomnia
- •Self-reported circadian phase irregularity/delay, including regular shift work
- •Previously diagnosed Narcolepsy, bipolar disorder or other major psychiatric disorders
- •Active alcohol abuse (Alcohol Use Disorders Identification Test, AUDIT-C ≥4) or drug abuse (Drug Abuse Screening Test, DAST-2 ≥1)
- •Current severe major depressive disorder (Patient Health Questionnaire-8, PHQ-8, score ≥20)
- •Use of seizure medication or seizure within the past 10 years
- •Untreated, previously diagnosed moderate to severe sleep apnea or excessive daytime sleepiness (defined by Epworth sleepiness scale score ≥16) with a self-reported sleep duration (>6 hours)
研究组 & 干预措施
Adapted 'Brief Behavioral Therapy for Insomnia' (BBTI)
All participants will receive the same intervention in this pilot study.
干预措施: Brief Behavioral Therapy for Insomnia (BBTI) (Behavioral)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b Endpoint
时间窗: Week 4
PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance. The minimum score is 8 and the maximum score is 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
次要结局
- PROMIS Sleep Impairment, 8a Endpoint(Week 4)
- PROMIS Sleep Impairment, 8a Follow-up(Week 12)
- Response to treatment (baseline to endpoint)(Week 0 vs. Week 4)
- PROMIS Sleep Disturbance, 8b Follow-up(Week 12)
- Response to treatment (baseline to follow-up)(Week 0 vs. Week 12)
- Remission of poor sleep symptoms (baseline to endpoint)(Week 0 vs. Week 4)
- Remission of poor sleep symptoms (baseline to follow-up)(Week 0 vs. Week 12)
- PROMIS Pain intensity, 3a (Endpoint)(Week 4)
- PROMIS Pain intensity, 3a (Follow-up)(Week 12)
- PROMIS Pain interference, 8a (Endpoint)(Week 4)
- PROMIS Pain interference, 8a (Follow-up)(Week 12)
- Insomnia Severity Index, ISI (Endpoint)(Week 4)
- Insomnia Severity Index, ISI (Follow-up)(Week 12)
研究者
Suzanne M. Bertisch, MD, MPH
Assistant Professor
Brigham and Women's Hospital