Cognitive Behavioral TherapyPhase 4SAFFIRENCT06684444
Evaluating Worksite Sleep Health Coaching in Firefighters: The Sleep Assistance for Firefighters Study
A Phase 4 study testing firefighter Sleep Health Coaching Intervention (ffSHC) in people with Cognitive Behavioral Therapy and Sleep Initiation and Maintenance Disorders, run by University of Arizona at 1 site in United States.
Trial summary
Insufficient sleep is a significant public health issue, particularly affecting shift workers like firefighters, nearly half of whom report short or poor-quality sleep, with 35-40% screening positive for sleep disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Behavioral Therapy, Sleep Initiation and Maintenance Disorders, Sleep Deprivation
- What is being tested?
- firefighter Sleep Health Coaching Intervention (ffSHC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Required to be employed as career (paid), uniformed fire service workers that must work in a participating fire agency.
- Must have moderate or more severe levels of sleep disturbances [item-level calibrated T-score of 55 or higher on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) questionnaire].
- Must have private access to a computer or phone for sleep health coaching.
Who cannot join
- Children younger than 18 years of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing Clinical Effectiveness and Implementation of Worksite Sleep Health Coaching in Firefighters
Insufficient sleep is a significant public health issue, particularly affecting shift workers like firefighters, nearly half of whom report short or poor-quality sleep, with 35-40% screening positive for sleep disorders. Cognitive Behavioral Therapy for Insomnia (CBTi) is a recommended and effective treatment, but access to such interventions remains low. This study will recruit 20 fire agencies in Arizona (400 firefighters) to test if a CBTi-informed intervention, including sleep health coaching and agency-wide promotion, improves sleep more effectively than usual care. The trial will also explore factors that influence successful implementation across agencies.
Read the detailed description
Insufficient sleep is a major public health crisis in the United States and worldwide, disproportionately affecting shift workers and other at-risk groups. Firefighters are one such group at heightened risk for disturbed sleep. Almost half of career firefighters report short sleep and poor sleep quality, and 35-40% of firefighters screen positive for a sleep disorder.
Evidence-based sleep health interventions are available and highly effective in eliciting behavioral change. The American College of Physicians recommends Cognitive Behavioral Therapy for Insomnia (CBTi) as the first-line treatment for Insomnia Disorder, and substantial evidence supports the efficacy of this therapy with comorbid conditions, including shiftwork and obstructive sleep apnea. Unfortunately, access to CBT-informed sleep health interventions remains low. Workplace wellness programs could be one way to help more firefighters receive sleep intervention.
This study will recruit 20 fire agencies in Arizona (n = 400 career firefighters) to examine whether a CBTi-informed intervention is more effective than usual care in reducing sleep disturbances or improving multidimensional sleep health. The intervention will last one year and will include telephone-administered sleep health coaching to firefighters, sleep health promotion to the agency and agency leaders, and external/internal facilitation strategies for implementation. The trial will also examine which combinations of factors are associated with successful agency implementation of the intervention. All participating agencies will receive the intervention; however, some agencies will wait longer to receive the intervention than others.
- Conditions
- Cognitive Behavioral Therapy, Sleep Initiation and Maintenance Disorders, Sleep Deprivation, Sleep Disorders, Intrinsic
- Being tested
- firefighter Sleep Health Coaching Intervention (ffSHC), Control (Minimally Enhanced Usual Care)
- Keywords
- CBTi, sleep deprivation, sleep disorders, firefighters, sleep health coaching
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Deprivation, Sleep Disorders, Intrinsic, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
firefighter Sleep Health Coaching Intervention (ffSHC)Behavioural
This multi-component intervention is based on principles of cognitive behavioral therapy for insomnia. It includes telephone-based sleep health coaching to individuals, targeted training and sleep health education to fire service leaders, agency-level sleep health promotion, and facilitation strategies to internal facilitators.
Control (Minimally Enhanced Usual Care)Behavioural
The control arm is minimally enhanced usual care. Usual care interventions for sleep disturbance include any health or wellness interventions administered by the agency on the topic of sleep, including occupational health intervention, employee assistance programs, education, signage, and webinars. The type and dose of care will be assessed at each timepoint. Minimal enhancement is a referral to the agency's Employee Assistance Program and will address the ethical problem in the control condition of identifying but not treating a sleep disturbance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (firefighter Sleep Health Coaching Intervention [ffSHC]) | Experimental | In this arm, fire service employees receive a structured sleep health intervention based on Cognitive Behavioral Therapy for Insomnia (CBTi). The intervention includes sleep health promotion, telephone-administered sleep coaching, and implementation strategies to promote better sleep practices. Each cluster will transition from the control arm to this intervention at a fixed time, and outcome data will be collected at multiple time points during and after the intervention phase to assess its effectiveness. Receives: Behavioral: firefighter Sleep Health Coaching Intervention (ffSHC) |
| Control (Minimally Enhanced Usual Care) | Active comparator | In this arm, fire service workers receive usual care with minimal enhancements but without the full sleep health intervention. During this phase, clusters will serve as the control group, and data on sleep health and related outcomes will be collected for comparison against the intervention phase. Each cluster will remain in this arm until a predetermined time point, at which they transition to the intervention arm after a one-month preparation phase. Receives: Behavioral: Control (Minimally Enhanced Usual Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Sleep Disturbance questionnaire
PROMIS measures are scored on the T-score metric. 50 is the mean score of a relevant reference population, and 10 is the standard deviation of that population. High scores mean more of the concept being measured.
Measured: 6 assessments, 6 months apart
Multidimensional sleep health (MSH) composite
The composite uses weighted summaries of the z-scores of four actigraphic sleep health dimensions: regularity, timing, sleep efficacy, sleep duration and two subjective sleep health dimensions: satisfaction and alertness, derived from items on the PROMIS-SD and PROMIS Sleep Related Impairment (PROMIS-SRI) scale respectively. High scores mean less of the concept being measured (i.e., worse sleep health).
Measured: 6 assessments, 6 months apart
Secondary outcomes (3)
PROMIS Sleep Related Impairment questionnaire
PROMIS measures are scored on the T-score metric. 50 is the mean score of a relevant reference population, and 10 is the standard deviation of that population. High scores mean more of the concept being measured.
Measured: 6 assessments, 6 months apart
Wake time after sleep onset (WASO), min - actigraphy
This index derived from wrist-worn actigraphy provides an average estimate of the total number of minutes awake after initial sleep onset. High scores mean more of the concept being measured.
Measured: 6 assessments, 6 months apart
Number of awakenings (NAW) - actigraphy
This index derived from wrist-worn actigraphy provides an average estimate of the total number of awakenings or arousals during the sleep period. High scores mean more of the concept being measured.
Measured: 6 assessments, 6 months apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start21 Oct 2024
- Primary completionMar 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavioral TherapyStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684444
- Sponsor's protocol ID
- STUDY00001612
- Other IDs
- R01HL162799
- Acronym
- SAFFIRE
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final datasets will be stripped of personally identifiable information (PII) data elements. IPD shared include: intervention condition, data from surveys and interviews, and individual-level summaries of actigraphic indices, heart rate, and blood pressure data collected across six timepoints (3 years). Survey responses related to sensitive information will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Clinical Effectiveness and Implementation of Worksite Sleep Health Coaching in Firefighters
- ClinicalTrials.gov ID
- NCT06684444
- Acronym / sponsor ID
- SAFFIRE / STUDY00001612
- Conditions
- Cognitive Behavioral Therapy, Sleep Initiation and Maintenance Disorders, Sleep Deprivation, Sleep Disorders, Intrinsic
- Keywords
- CBTi, sleep deprivation, sleep disorders, firefighters, sleep health coaching
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 Nov 2024 (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.
Insufficient sleep is a significant public health issue, particularly affecting shift workers like firefighters, nearly half of whom report short or poor-quality sleep, with 35-40% screening positive for sleep disorders. Cognitive Behavioral Therapy for Insomnia (CBTi) is a recommended and effective treatment, but access to such interventions remains low. This study will recruit 20 fire agencies in Arizona (400 firefighters) to test if a CBTi-informed intervention, including sleep health coaching and agency-wide promotion, improves sleep more effectively than usual care. The trial will also explore factors that influence successful implementation across agencies.
Detailed description
Insufficient sleep is a major public health crisis in the United States and worldwide, disproportionately affecting shift workers and other at-risk groups. Firefighters are one such group at heightened risk for disturbed sleep. Almost half of career firefighters report short sleep and poor sleep quality, and 35-40% of firefighters screen positive for a sleep disorder.
Evidence-based sleep health interventions are available and highly effective in eliciting behavioral change. The American College of Physicians recommends Cognitive Behavioral Therapy for Insomnia (CBTi) as the first-line treatment for Insomnia Disorder, and substantial evidence supports the efficacy of this therapy with comorbid conditions, including shiftwork and obstructive sleep apnea. Unfortunately, access to CBT-informed sleep health interventions remains low. Workplace wellness programs could be one way to help more firefighters receive sleep intervention.
This study will recruit 20 fire agencies in Arizona (n = 400 career firefighters) to examine whether a CBTi-informed intervention is more effective than usual care in reducing sleep disturbances or improving multidimensional sleep health. The intervention will last one year and will include telephone-administered sleep health coaching to firefighters, sleep health promotion to the agency and agency leaders, and external/internal facilitation strategies for implementation. The trial will also examine which combinations of factors are associated with successful agency implementation of the intervention. All participating agencies will receive the intervention; however, some agencies will wait longer to receive the intervention than others.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (firefighter Sleep Health Coaching Intervention [ffSHC]) | Experimental | Behavioral: firefighter Sleep Health Coaching Intervention (ffSHC)In this arm, fire service employees receive a structured sleep health intervention based on Cognitive Behavioral Therapy for Insomnia (CBTi). The intervention includes sleep health promotion, telephone-administered sleep coaching, and implementation strategies to promote better sleep practices. Each cluster will transition from the control arm to this intervention at a fixed time, and outcome data will be collected at multiple time points during and after the intervention phase to assess its effectiveness. |
| Control (Minimally Enhanced Usual Care) | Active comparator | Behavioral: Control (Minimally Enhanced Usual Care)In this arm, fire service workers receive usual care with minimal enhancements but without the full sleep health intervention. During this phase, clusters will serve as the control group, and data on sleep health and related outcomes will be collected for comparison against the intervention phase. Each cluster will remain in this arm until a predetermined time point, at which they transition to the intervention arm after a one-month preparation phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Required to be employed as career (paid), uniformed fire service workers that must work in a participating fire agency.
- Must have moderate or more severe levels of sleep disturbances [item-level calibrated T-score of 55 or higher on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) questionnaire].
- Must have private access to a computer or phone for sleep health coaching.
Key exclusion criteria (1 listed)
- Children younger than 18 years of age.
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 |
|---|---|---|
| firefighter Sleep Health Coaching Intervention (ffSHC)This multi-component intervention is based on principles of cognitive behavioral therapy for insomnia. It includes telephone-based sleep health coaching to individuals, targeted training and sleep health education to fire service leaders, agency-level sleep health promotion, and facilitation strategies to internal facilitators. | Behavioural | Intervention (firefighter Sleep Health Coaching Intervention [ffSHC]) |
| Control (Minimally Enhanced Usual Care)The control arm is minimally enhanced usual care. Usual care interventions for sleep disturbance include any health or wellness interventions administered by the agency on the topic of sleep, including occupational health intervention, employee assistance programs, education, signage, and webinars. The type and dose of care will be assessed at each timepoint. Minimal enhancement is a referral to the agency's Employee Assistance Program and will address the ethical problem in the control condition of identifying but not treating a sleep disturbance. | Behavioural | Control (Minimally Enhanced Usual Care) |
Primary outcome
PROMIS Sleep Disturbance questionnaire
Time frame: 6 assessments, 6 months apart
PROMIS measures are scored on the T-score metric. 50 is the mean score of a relevant reference population, and 10 is the standard deviation of that population. High scores mean more of the concept being measured.
Multidimensional sleep health (MSH) composite
Time frame: 6 assessments, 6 months apart
The composite uses weighted summaries of the z-scores of four actigraphic sleep health dimensions: regularity, timing, sleep efficacy, sleep duration and two subjective sleep health dimensions: satisfaction and alertness, derived from items on the PROMIS-SD and PROMIS Sleep Related Impairment (PROMIS-SRI) scale respectively. High scores mean less of the concept being measured (i.e., worse sleep health).
3 secondary outcomes
PROMIS Sleep Related Impairment questionnaire
Time frame: 6 assessments, 6 months apart
Wake time after sleep onset (WASO), min - actigraphy
Time frame: 6 assessments, 6 months apart
Number of awakenings (NAW) - actigraphy
Time frame: 6 assessments, 6 months apart
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. Final datasets will be stripped of personally identifiable information (PII) data elements. IPD shared include: intervention condition, data from surveys and interviews, and individual-level summaries of actigraphic indices, heart rate, and blood pressure data collected across six timepoints (3 years). Survey responses related to sensitive information will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing firefighter Sleep Health Coaching Intervention (ffSHC) in people with Cognitive Behavioral Therapy and Sleep Initiation and Maintenance Disorders, run by University of Arizona 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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 16 Jul 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
PROMIS Sleep Disturbance questionnaire (time frame: 6 assessments, 6 months apart). The study lists 2 primary outcomes in all. 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 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.