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Intervention (firefighter Sleep Health Coaching Intervention [ffSHC]) for Insomnia (SAFFIRE Trial)

Phase 4

Waitlist Available

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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 \[item-level calibrated T-score of 55 or higher on the 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) questionnaire\].

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 assessments, approximately 1 year apart

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.

Eligible Conditions

Insomnia
Cognitive Behavioral Therapy
Sleep Deprivation
Sleep Disorders
Sleep State Misperception

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 assessments, approximately 1 year apart

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 assessments, approximately 1 year apart

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 assessments, approximately 1 year apart for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Multidimensional sleep health (MSH) composite

PROMIS Sleep Disturbance questionnaire

Secondary study objectives

Number of awakenings (NAW) - actigraphy

PROMIS Sleep Related Impairment questionnaire

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

Other study objectives

Blood pressure

Heart rate

Occupational health clinic assessments-1, CVD

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention (firefighter Sleep Health Coaching Intervention [ffSHC])Experimental Treatment1 Intervention

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.

Group II: Control (Minimally Enhanced Usual Care)Active Control1 Intervention

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.

0 / 3Eligibility criteria met