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

400 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment firefighter Sleep Health Coaching Intervention (ffSHC) for insomnia?

Research shows that cognitive behavioral therapy for insomnia (CBT-I), which is a key component of the firefighter Sleep Health Coaching Intervention, is effective in improving sleep outcomes. Studies on similar CBT-I-based mobile apps and group therapies have shown improvements in insomnia symptoms, sleep quality, and daytime functioning among veterans and military personnel. ^{1 2 3 4 5}

Is Sleep Health Coaching for Insomnia safe for humans?

The FIT-IN sleep intervention for firefighters, which is similar to Sleep Health Coaching, showed improvements in sleep and other health measures without reporting any safety concerns in a study with 39 participants. Further studies are needed to confirm its safety and effectiveness. ^{1 6 7 8 9}

How is the firefighter Sleep Health Coaching Intervention (ffSHC) different from other treatments for insomnia?

The firefighter Sleep Health Coaching Intervention (ffSHC) is unique because it is specifically tailored to address the sleep challenges faced by firefighters, such as irregular sleep patterns due to shift work. It incorporates elements of behavior therapy and imagery rehearsal therapy, focusing on practical strategies to improve sleep efficiency and reduce insomnia and nightmares, which are common in this population. ^{1 6 7 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary real-world promise of a manualized group-based cognitive behavioral therapy for insomnia protocol for veterans. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia treatment in a military deployed operational setting utilizing enlisted combat medics: a Quality and Process Improvement Project. [2018]

4. England pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial of the Insomnia Coach Mobile App to Assess Its Feasibility, Acceptability, and Potential Efficacy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Brief behavioral treatment for insomnia: Treatment schedule and training feasibility in the military. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Development of a Sleep Intervention for Firefighters: The FIT-IN (Firefighter's Therapy for Insomnia and Nightmares) Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Randomized, Prospective Study of the Impact of a Sleep Health Program on Firefighter Injury and Disability. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Common sleep disorders increase risk of motor vehicle crashes and adverse health outcomes in firefighters. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring Clinical Trials to Manage Firefighters' Sleep Quality: A PRISMA Compliant Systematic Review. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Implementing a Sleep Health Education and Sleep Disorders Screening Program in Fire Departments: A Comparison of Methodology. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Mental Health of Canadian Firefighters: The Impact of Sleep. [2021]