Sleep Bootcamp: A Pilot Tele-Sleep Program for Former National Football League (NFL) Players

Mass General Brigham

Status

Completed

Conditions

Quality of Life

Insomnia

Pain

Sleep

Treatments

Behavioral: Brief Behavioral Therapy for Insomnia (BBTI)

Study type

Interventional

Funder types

Other

Identifiers

NCT04159233

2019P002027

Details and patient eligibility

About

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.

Full description

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.

Enrollment

42 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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

Exclusion criteria

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)