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

NCT06684444 | Enrolling By Invitation Phase 4

• 2 other identifiers: STUDY00001612R01HL162799
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Behavioral Therapy; Sleep Initiation and Maintenance Disorders; Sleep Deprivation; Sleep Disorders, Intrinsic

Keywords

CBTi; sleep deprivation; sleep disorders; firefighters; sleep health coaching

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  6 assessments, 6 months apart

Secondary Outcomes (3)

• PROMIS Sleep Related Impairment questionnaire

  6 assessments, 6 months apart

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

  6 assessments, 6 months apart

• Number of awakenings (NAW) - actigraphy

  6 assessments, 6 months apart

Other Outcomes (5)

• Blood pressure

  6 assessments, 6 months apart

• Heart rate

  6 assessments, 6 months apart

• Occupational health clinic assessments-1, CVD

  4 assessments, approximately 1 year apart

Study Arms (2)

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.

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.

Behavioral: Control (Minimally Enhanced Usual Care)

Interventions

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.

Intervention (firefighter Sleep Health Coaching Intervention [ffSHC])

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.

Control (Minimally Enhanced Usual Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Children younger than 18 years of age.

Sponsors & Collaborators

• University of Arizona: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Deprivation; Sleep Disorders, Intrinsic; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 12, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available on National Sleep Research Resource (NSRR) repository to other users no later than the time of an associated publication or at the end of the performance period, whichever comes first. Primary data will be available for a minimum of 10 years after the end of the performance period, consistent with University of Arizona policy.
• Access Criteria: Access to the resources at NSRR is controlled by per-dataset-access control, and access is only granted to individuals who have completed the web-based Data Access and Use Agreement (DAUA). Each DAUA submission is reviewed by the NSRR Review Committee, and reviewers ascertain that use of data appears appropriate with the intention of data collected and that there is a commitment to keep the data stored securely by the end-user. NSRR DAUAs expire 3 years from the date access is granted and can be renewed by either submitting a new request for data access or by requesting an extension of the agreement in writing to the NSRR Review Committee.

Locations

US (1)