Sleep Health Coaching for Insomnia

(SAFFIRE Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Arizona

Disqualifiers: Children younger than 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special sleep coaching program can assist firefighters who struggle with sleep. It compares a new coaching approach, the firefighter Sleep Health Coaching Intervention (ffSHC), based on Cognitive Behavioral Therapy for Insomnia, to the usual care they receive. Firefighters in Arizona with significant sleep issues and access to a phone or computer for coaching might be suitable candidates. The goal is to improve sleep quality and understand what makes the program effective across different fire agencies. As a Phase 4 trial, this research explores how the already FDA-approved and effective treatment can benefit more firefighters.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on sleep health coaching and does not mention medication changes.

What is the safety track record for the firefighter Sleep Health Coaching Intervention (ffSHC)?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBTi) is a proven and safe way to improve sleep. The firefighter Sleep Health Coaching Intervention (ffSHC) builds on this by providing personalized sleep coaching and encouraging better sleep habits.

Studies have found that sleep health programs, like the one being tested, can lead to positive results without major risks. For example, one study showed that workplace sleep health programs, which include education and checking for sleep disorders, can reduce injuries and work absences among firefighters. This indicates the program is not only safe but also beneficial for overall health and safety.

Since this study is in a later phase, earlier trials have already demonstrated the program's safety. Overall, evidence suggests that the ffSHC is well-tolerated, with no major side effects reported. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the firefighter Sleep Health Coaching Intervention (ffSHC) because it takes a fresh approach to tackling insomnia, especially in high-stress professions like firefighting. Unlike standard treatments for insomnia, such as medications or traditional Cognitive Behavioral Therapy for Insomnia (CBTi), this program combines personalized sleep health promotion with telephone-administered sleep coaching, making it more accessible and tailored to the unique demands of firefighters. By integrating implementation strategies to promote better sleep practices, ffSHC aims to not only improve sleep quality but also support long-term lifestyle changes, which is particularly beneficial for those with irregular work hours and high-pressure environments.

What evidence suggests that the firefighter Sleep Health Coaching Intervention could be effective for improving sleep in firefighters?

Past studies have shown that Cognitive Behavioral Therapy for Insomnia (CBTi) effectively improves sleep quality and reduces sleep problems. Research indicates that sleep health programs based on CBTi can lead to significant behavioral changes. These programs help people sleep better by teaching them to change their thoughts and habits about sleep. This trial will test the firefighter Sleep Health Coaching Intervention (ffSHC), which uses CBTi, to determine its effectiveness in helping firefighters, who often struggle with sleep, improve their sleep quality. Previous research suggests that firefighters participating in this structured sleep health program may experience better sleep quality. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for firefighters in Arizona who may be experiencing poor sleep quality or disorders like insomnia, parasomnia, and shift work sleep disorder. Participants should be part of an agency willing to implement the study's interventions.

Inclusion Criteria

I am a paid firefighter working at a participating fire agency.

I have moderate to severe sleep problems.

I have a computer or phone to use for sleep health coaching.

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Phase

Fire service workers receive usual care with minimal enhancements, serving as the control group.

1 month

Data collected at multiple time points

Intervention Phase

Fire service employees receive a structured sleep health intervention based on CBTi, including sleep health promotion and telephone-administered sleep coaching.

1 year

Data collected at multiple time points

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• firefighter Sleep Health Coaching Intervention (ffSHC)

Trial Overview The study tests a firefighter-specific Sleep Health Coaching Intervention (ffSHC) informed by Cognitive Behavioral Therapy for Insomnia against minimally enhanced usual care to see if it improves sleep among firefighters.

How Is the Trial Designed?

Group I: Intervention (firefighter Sleep Health Coaching Intervention [ffSHC]) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The CBT-i Coach mobile app significantly improved subjective sleep outcomes in veterans, with participants reporting reduced insomnia and better sleep quality after a 6-week intervention, despite a decrease in objective sleep time.

The study highlights the importance of using both subjective and objective sleep measures, as the objective data revealed a decrease in sleep time and no changes in REM sleep or sleep efficiency, suggesting potential undiagnosed sleep apnea in participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. Reilly, ED., Robinson, SA., Petrakis, BA., et al.[2020]

Group-based cognitive behavioral therapy for insomnia (CBT-I) is a feasible and acceptable treatment for veterans with insomnia, showing medium to large effect sizes in improving various sleep measures.

The treatment demonstrated initial effectiveness in reducing insomnia symptoms, with improvements maintained for at least one month after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary real-world promise of a manualized group-based cognitive behavioral therapy for insomnia protocol for veterans. Koffel, E., Farrell-Carnahan, L.[2018]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11159514

Project Details - NIH RePORTER This project aims to increase access to sleep health intervention by testing and implementing an evidence-based sleep health coaching program within the fire ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06684444

Study Details | NCT06684444 | Evaluating Worksite Sleep ... 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 ...

3. clinicaltrial.be clinicaltrial.be/en/details/458230?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Evaluating Worksite Sleep Health Coaching in Firefighters... Evidence-based sleep health interventions are available and highly effective in eliciting behavioral change. The American College of Physicians ...

4. ctv.veeva.com ctv.veeva.com/study/evaluating-worksite-sleep-health-coaching-in-firefighters-the-sleep-assistance-for-firefighters-stu

Evaluating Worksite Sleep Health Coaching in Firefighters Almost half of career firefighters report short sleep and poor sleep quality, and 35-40% of firefighters screen positive for a sleep disorder.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722925000999

Treatment Development Report of an Intensive Group ... Open pilot evaluation suggests that participants experienced reductions in PTSD symptoms, insomnia, and nightmares, and were satisfied with the ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667343621000147

The effects of sleep on firefighter occupational performance ... We found that firefighters with poor sleep measures had worse cognitive performance and overall health, but physical capabilities were not impacted by acute ...

7. academic.oup.com academic.oup.com/sleep/article/40/1/zsw001/2656862

Randomized, Prospective Study of the Impact of a Sleep ... Conclusions: A firefighter workplace-based SHP providing sleep health education and sleep disorders screening opportunity can reduce injuries and work loss due ...

8. stacks.cdc.gov stacks.cdc.gov/view/cdc/229988/cdc_229988_DS1.pdf

Job Stress and Sleep Disturbances Among Career ... 7,8,13 Sleep problems among firefighters negatively influence not only their physical health status but also their safety outcomes including ...