SleepNCT04159233
Sleep Bootcamp: A Pilot Tele-Sleep Program for Former National Football League (NFL) Players
A study testing Brief Behavioral Therapy for Insomnia (BBTI) in people with Sleep and Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- Brief Behavioral Therapy for Insomnia (BBTI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 7 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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
- Being tested
- Brief Behavioral Therapy for Insomnia (BBTI)
- Keywords
- sleep, pain, professional athlete, National Football League, Behavioral intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Therapy for Insomnia (BBTI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adapted 'Brief Behavioral Therapy for Insomnia' (BBTI) | Other | All participants will receive the same intervention in this pilot study. Receives: Behavioral: Brief Behavioral Therapy for Insomnia (BBTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b Endpoint
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.
Measured: Week 4
Secondary outcomes (13)
PROMIS Sleep Disturbance, 8b Follow-up
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.
Measured: Week 12
PROMIS Sleep Impairment, 8a Endpoint
PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness during the past seven days. The measure includes 8-items with higher scores indicating greater sleep impairment. The minimum score is 8 and the maximum score 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
Measured: Week 4
PROMIS Sleep Impairment, 8a Follow-up
PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness 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 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.
Measured: Week 12
Response to treatment (baseline to endpoint)
Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined response to treatment as a change in the PSQI score of ≥3 points (Buysse, 2011). The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval. The minimum score is 0 and maximum score is 21. Higher scores indicate worse sleep quality.
Measured: Week 0 vs. Week 4
Response to treatment (baseline to follow-up)
Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined response to treatment as a change in the PSQI score of ≥3 points (Buysse, 2011). The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval. The minimum score is 0 and maximum score is 21. Higher scores indicate worse sleep quality.
Measured: Week 0 vs. Week 12
Remission of poor sleep symptoms (baseline to endpoint)
Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined remission as the response criterion (change in the PSQI score of ≥3 points) plus a final PSQI score <5 (Buysse, 2011). The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval. The minimum score is 0 and maximum score is 21. Higher scores indicate worse sleep quality.
Measured: Week 0 vs. Week 4
Remission of poor sleep symptoms (baseline to follow-up)
Previous 'Brief Behavioral Treatment for Insomnia' interventions have defined remission as the response criterion (change in the PSQI score of ≥3 points) plus a final PSQI score <5 (Buysse, 2011). The PSQI, or the Pittsburgh Sleep Quality Index, is a validated instrument which assesses self-reported sleep quality and disturbances over a 1-month interval. The minimum score is 0 and maximum score is 21. Higher scores indicate worse sleep quality.
Measured: Week 0 vs. Week 12
PROMIS Pain intensity, 3a (Endpoint)
PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Item responses are combined to yield a T-score with population mean of 50 and standard deviation of 10.
Measured: Week 4
PROMIS Pain intensity, 3a (Follow-up)
PROMIS Pain intensity 3a is a self-report measure that assesses how much a person hurts (intensity or severity) in the past 7 days. The measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5, therefore the response range is 3-15 with higher scores indicating greater pain intensity. Item responses are combined to yield a T-score with population mean of 50 and standard deviation of 10.
Measured: Week 12
PROMIS Pain interference, 8a (Endpoint)
PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days.
The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference. Item responses are combined to yield a standardized T-score with a mean of 50, and a standard deviation of 10.
Measured: Week 4
PROMIS Pain interference, 8a (Follow-up)
PROMIS Pain interference 8a assesses self-reported consequences of pain on relevant aspects of one's life in the past 7 days.
The measure includes 8-items rating pain from "Not at all" = 1 to "Very much" = 5, therefore the response range is 8-40 with higher scores indicating greater pain interference. Item responses are combined to yield a standardized T-score with a mean of 50, and a standard deviation of 10.
Measured: Week 12
Insomnia Severity Index, ISI (Endpoint)
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: Week 4
Insomnia Severity Index, ISI (Follow-up)
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start14 Jan 2020
- Primary completion30 Jun 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Suzanne M. Bertisch, MD, MPH, Brigham and Women's Hospital
- Investigators
- Suzanne Bertisch, MD, MPH, Principal investigator, Assistant Professor in Medicine, Physician/Clinical Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159233
- Sponsor's protocol ID
- 2019P002027
- Status last verified
- Sep 2020
- First submitted
- 29 Oct 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Developing A Scalable Sleep Health Intervention to Improve Pain, Quality of Life, and Health in Former NFL Players
- ClinicalTrials.gov ID
- NCT04159233
- Acronym / sponsor ID
- 2019P002027
- Conditions
- Sleep, Insomnia, Pain, Quality of Life
- Keywords
- sleep, pain, professional athlete, National Football League, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapted 'Brief Behavioral Therapy for Insomnia' (BBTI) | Other | Behavioral: Brief Behavioral Therapy for Insomnia (BBTI)All participants will receive the same intervention in this pilot study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Adapted 'Brief Behavioral Therapy for Insomnia' (BBTI) |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b Endpoint
Time frame: 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.
13 secondary outcomes
PROMIS Sleep Disturbance, 8b Follow-up
Time frame: Week 12
PROMIS Sleep Impairment, 8a Endpoint
Time frame: Week 4
PROMIS Sleep Impairment, 8a Follow-up
Time frame: Week 12
Response to treatment (baseline to endpoint)
Time frame: Week 0 vs. Week 4
Response to treatment (baseline to follow-up)
Time frame: Week 0 vs. Week 12
Remission of poor sleep symptoms (baseline to endpoint)
Time frame: Week 0 vs. Week 4
Remission of poor sleep symptoms (baseline to follow-up)
Time frame: Week 0 vs. Week 12
PROMIS Pain intensity, 3a (Endpoint)
Time frame: Week 4
PROMIS Pain intensity, 3a (Follow-up)
Time frame: Week 12
PROMIS Pain interference, 8a (Endpoint)
Time frame: Week 4
PROMIS Pain interference, 8a (Follow-up)
Time frame: Week 12
Insomnia Severity Index, ISI (Endpoint)
Time frame: Week 4
Insomnia Severity Index, ISI (Follow-up)
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Bertisch, MD, MPH principal investigator
Assistant Professor in Medicine, Physician/Clinical Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Therapy for Insomnia (BBTI) in people with Sleep and Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b Endpoint (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.