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Enrolling by Invitation

NCT Number: NCT06684444

Evaluating Worksite Sleep Health Coaching in Firefighters: The Sleep Assistance for Firefighters Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Arizona

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Children younger than 18 years of age.

Treatment and study plan

firefighter Sleep Health Coaching Intervention (ffSHC)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. PROMIS Sleep Related Impairment 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.

  2. Wake time after sleep onset (WASO), min - actigraphy

    Time frame: 6 assessments, 6 months apart

    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.

  3. Number of awakenings (NAW) - actigraphy

    Time frame: 6 assessments, 6 months apart

    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.

Other outcomes

  1. Blood pressure

    Time frame: 6 assessments, 6 months apart

    Systolic and diastolic blood pressure (mm Hg)

  2. Heart rate

    Time frame: 6 assessments, 6 months apart

    Nocturnal heart rate, difference between mean nocturnal and daytime heart rate

  3. Occupational health clinic assessments-1, CVD

    Time frame: 4 assessments, approximately 1 year apart

    cholesterol

  4. Occupational health clinic assessments-2, CVD

    Time frame: 4 assessments, approximately 1 year apart

    body mass index (BMI)

  5. Occupational health clinic assessments-3, CVD

    Time frame: 4 assessments, approximately 1 year apart

    blood pressure (mm Hg)

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Assessing Clinical Effectiveness and Implementation of Worksite Sleep Health Coaching in Firefighters

Acronym: SAFFIRE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 12, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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