Pain Clinical Trial
Official title:
Pilot Study: Developing A Scalable Sleep Health Intervention to Improve Pain, Quality of Life, and Health in Former NFL Players
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.
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. ;
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