A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters
NCT ID: NCT05087121
Last Updated: 2022-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2021-02-16
2022-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) [Treatment Group]
The Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) is a 6-week training course that focuses on mitigating poor sleep quality and promoting the adoption of behaviors conducive to quality sleep. This course includes modules on developing habits conducive to better sleep, adapting variable bedroom environments, and establishing techniques to reduce worry and frustration around falling asleep while recognizing and working through barriers unique to the career of firefighting.
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.
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
No Intervention Control Group
Non-Intervention Control Group (NIC) will not receive training during the course of the study, but will be offered the opportunity to receive training after the study ends.
No interventions assigned to this group
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* full-time professional firefighter
* At least 18 years of age
* A global Pittsburgh Sleep Quality Index score ≥ 5 (Grandner et al., 2006)
* Be willing and able to participate in all study activities including pre-, post-, and 3-month follow up assessments and 6-weeks of the CBT-I intervention
* Agree to random assignment to one of two conditions (treatment or control group)
* Have access to an email account
* Be willing to wear the Fitbit Inspire HR device throughout the duration of the intervention and for two weeks following completion of the 6-week intervention
Exclusion Criteria
* Unwillingness to give written informed consent
18 Years
ALL
Yes
Sponsors
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Pacific University
OTHER
Responsible Party
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Principal Investigators
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Kaylie A Green, M.S.
Role: PRINCIPAL_INVESTIGATOR
Pacific University
Michael Christopher, Ph.D.
Role: STUDY_CHAIR
Pacific University
Locations
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Pacific University
Forest Grove, Oregon, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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1684868-2
Identifier Type: -
Identifier Source: org_study_id
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