A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters
1 other identifier
interventional
23
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2021
CompletedFirst Submitted
Initial submission to the registry
June 28, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedDecember 1, 2022
September 1, 2022
11 months
June 28, 2021
November 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in Scores on the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to assess sleep quality and sleep disfunction throughout the previous month. Global scores range between 0-21 with higher scores indicating greater sleep dysfunction.
Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
Total Sleep Time Change as Measured by Actigraphy in the Fitbit Inspire HR
Fitbit Inspire HR wrist worn devices will be used to assess mean sleep patterns and sleep-related activity. The Fitbit Inspire HR may be worn consistently for up to 5-days and records wrist movement and heart rate variability to estimate sleep onset, waking, and sleep stages without need for the wearer to actively manipulate the device.
Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention)
Feasibility as measured by attendance, attrition, and adherence to intervention components.
Feasibility will be measured via attendance, attrition rates, and completion of sleep diaries Participant weekly CBT-I attendance will be tracked and analyzed based upon average percentage of total number of sessions attended. Adherence to intervention components will be tracked via compliance with recommendations for the previous week. After each session, sleep diaries for that week will be examined by research assistants and recorded dichotomously as to whether "Yes, the participant was adherent" or "No, the participant was not adherent". An adherence percentage will be calculated.
From intervention Week 1 to intervention Week 6
Acceptability as measured by mean acceptability ratings on four Likert-style questions.
Acceptability will be assessed using four self-report questions derived from similar studies, and calculated via mean acceptability ratings on a scale of 0-6. These items will include the degree to which the participant liked the program, whether they found the home practice/requirements reasonable, whether they would recommend the program, and whether they would take the program again in the future. Each item is responded to on a 7-point Likert-type scale ranging from 0 to 6, with higher scores indicating greater acceptability.
6 weeks (i.e., post-intervention)
Secondary Outcomes (6)
Depression, Anxiety, and Stress as Measured Through the Depression, Anxiety, and Stress Scales 21 (DASS-21).
Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
PTSD as Measured Through the PTSD Checklist for DSM-5 (PCL-5)
Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
General Health as Measured Through the Medical Outcomes Study 12-item Short-Form Survey (SF12v2)
Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
Family Functioning as Measured Through the McMaster Family Assessment Device - General Functioning Scale (FAD-GFS)
Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
Vigilant Attention as Measured Through the Psychomotor Vigilance Task (PVT).
Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
- +1 more secondary outcomes
Study Arms (2)
Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) [Treatment Group]
EXPERIMENTALThe 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.
No Intervention Control Group
NO INTERVENTIONNon-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.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- English-speaking
- 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
You may not qualify if:
- Endorsement of prior involvement in formal CBT-I interventions
- Unwillingness to give written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pacific University
Forest Grove, Oregon, 97116, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaylie A Green, M.S.
Pacific University
- STUDY CHAIR
Michael Christopher, Ph.D.
Pacific University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2021
First Posted
October 21, 2021
Study Start
February 16, 2021
Primary Completion
December 31, 2021
Study Completion
July 31, 2022
Last Updated
December 1, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- The data generated in this study will be presented at regional, national, and international conferences and published in peer-reviewed journals in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central.
- Access Criteria
- Data sharing agreements will be required to ensure that the data will be used only for research purposes and will not be transferred to others without first notifying and receiving permission. The data will be stored in SPSS format by the multiple principal investigators and, following completion of a data sharing agreement, will be distributed directly by one of the multiple principal investigators via electronic file.
We are committed to advancing knowledge in the scientific community and the role that data sharing takes in this endeavor. We agree to share all final, de-identified research data as broadly as possible to the extent consistent with applicable laws, regulations, rules, and policies. As requested, aggregate data in the form of summary statistics and tables will be shared, with description of analytical methods used. Data requests will be carefully evaluated to insure that the data are sought for scientifically-sound reasons, that the individual requesting the data is professionally qualified, and that the data to be shared are properly de-identified so as to protect the rights of participants. When de-identifying the data, care will be taken to remove identifiers while maintaining the scientific integrity of the data. Removing both direct and indirect identities will be undertaken to insure that even deductive disclosure of identity is unlikely.