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

NCT ID: NCT04159233

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2020-09-07

Brief Summary

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.

Detailed 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.

Conditions

Sleep; Insomnia; Pain; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adapted 'Brief Behavioral Therapy for Insomnia' (BBTI)

All participants will receive the same intervention in this pilot study.

Group Type: OTHER

Brief Behavioral Therapy for Insomnia (BBTI)

Intervention Type: BEHAVIORAL

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) and will be administered through weekly phone calls with a trained sleep interventionist over 4-weeks.

Interventions

Brief Behavioral Therapy for Insomnia (BBTI)

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) and will be administered through weekly phone calls with a trained sleep interventionist over 4-weeks.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Suzanne M. Bertisch, MD, MPH

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Bertisch, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor in Medicine, Physician/Clinical Investigator

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2019P002027

Identifier Type: -

Identifier Source: org_study_id