NCT05087121

A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Pacific University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary aim of this study is to investigate the feasibility, acceptability, and preliminary efficacy of an adapted Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention in improving sleep in a firefighter population.

Detailed description

After being informed about the study and potential risks, participants will be randomized to the intervention group (group to receive CBT-I) or the no-intervention control group. All participants in the study will complete three assessment visits; one prior to the start of the intervention, one immediately following the 6-week intervention, and one 3-months post-intervention. The intervention group will engage in 6-weeks of CBT-I training aimed at targeting sleep and sleep-related concerns faced as a result of occupational considerations.

Conditions

• Insomnia
• Shift-Work Related Sleep Disturbance

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F)	The Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) 6-week training course has been derived from existing Cognitive Behavioral Therapy for Insomnia (CBT-I) group therapy protocols. Participants in this intervention will receive psychoeducation on sleep and practice skills standard of CBT-I including, stimulus control techniques, sleep restriction, counter-arousal skills, cognitive restructuring, sleep hygiene, goal setting, and relapse prevention skills. Weekly sessions will include discussions regarding difficulties specific to occupational barriers and how to mitigate the impact of occupational requirements on sleep quality.
DEVICE	Fitbit Inspire HR Wrist Worn Device (NCT04176926)	The Fitbit Inspire HR wrist worn device will be worn by eligible participants throughout the duration of the intervention and for two weeks following completion of the 6-week intervention to collect objective data on enduring sleep changes. This device is an FDA-registered medical device that is not the object of investigation and is being used "on label" only to gather data. 501(K) Number: K200948 Device Name: Fitbit ECG App Regulation Number: 870.2345 Classification Product Code: QDA Clinical Trials: NCT04176926

Timeline

• Start date: 2021-02-16
• Primary completion: 2021-12-31
• Completion: 2022-07-31
• First posted: 2021-10-21
• Last updated: 2022-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study