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InsomniaNCT05087121

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

A study testing Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) and Fitbit Inspire HR Wrist Worn Device (NCT04176926) in people with Insomnia and Shift-Work Related Sleep Disturbance, run by Pacific University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) and Fitbit Inspire HR Wrist Worn Device (NCT04176926)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
16 Feb 2021to 31 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Endorsement of prior involvement in formal CBT-I interventions
  • Unwillingness to give written informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pacific University

    Forest Grove, Oregon, 97116

Other trials in United States

About this study

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.

Read the 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.

Being tested
Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F), Fitbit Inspire HR Wrist Worn Device (NCT04176926)
Keywords
Sleep, Firefighter, CBT-I
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F)Behavioural

    Also called CBT-I, Cognitive Behavioral Therapy - Insomnia

    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)Device

    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

Study groups in NCT05087121
Study groupRoleWhat they receive
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.
Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F); Device: Fitbit Inspire HR Wrist Worn Device (NCT04176926)
No Intervention Control GroupNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)

  2. 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.

    Measured: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention)

  3. 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.

    Measured: From intervention Week 1 to intervention Week 6

  4. 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.

    Measured: 6 weeks (i.e., post-intervention)

Secondary outcomes (6)

  1. Depression, Anxiety, and Stress as Measured Through the Depression, Anxiety, and Stress Scales 21 (DASS-21).

    The Depression, Anxiety, Stress Scales 21-item measure (DASS-21) measures self-report ratings of depression, anxiety, stress symptoms. Items are responded to on a 4-point Likert-type scale ranging from 0 (Did not apply to me at all) and 3 (Applied to me very much or most of the time). Scores range between 0 and 120 for the DASS-21 total score. Higher scores indicate a greater severity of depression, anxiety, and stress.

    Measured: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)

  2. PTSD as Measured Through the PTSD Checklist for DSM-5 (PCL-5)

    The PTSD Checklist for DSM-5 (PCL-5) measures self-reported PTSD symptoms. Items are responded to on a 5-point Likert-type scale ranging between 0 (Not at all) to 4 (Extremely) with higher scores indicating greater severity of PTSD symptoms. Items are summed to create a total score ranging between 0-80 and scores greater than 33 indicate probable PTSD.

    Measured: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)

  3. General Health as Measured Through the Medical Outcomes Study 12-item Short-Form Survey (SF12v2)

    The Medical Outcomes Study 12-item Short-Form Survey (SF12v2) measures self-reported general health. The SF12v2 is a 12-item self-report that contains eight subscales: physical functioning, role-physical (i.e., role limitations related to physical health), bodily pain, general health, vitality, social functioning, role-emotional (i.e., emotional problems resulting in role limitations), and mental health. Higher scores indicate more favorable states of health.

    Measured: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)

  4. Family Functioning as Measured Through the McMaster Family Assessment Device - General Functioning Scale (FAD-GFS)

    The McMaster Family Assessment Device - General Functioning Scale (FAD-GFS) measures self-reported family functioning. The FAD-GFS is a 12-item self-report subscale of the larger 60-item FAD measure, that assesses overall health and pathology of the family. Items on the FAD-GFS are responded to on a 4-point Likert-type scale ranging between 1 (Strongly Agree) and 4 (Strongly Disagree). Higher total scores indicate more problematic family functioning.

    Measured: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)

  5. Vigilant Attention as Measured Through the Psychomotor Vigilance Task (PVT).

    The Psychomotor Vigilance Task (PVT) is a continuous performance task commonly used to objectively assess sleep-related cognitive deficits in vigilant attention. The PVT, administered remotely via Inquisit Web software (Millisecond Software LLC, US) will be used in this study. Inter-stimulus intervals are set to vary randomly between 2-10 seconds and subjects are to respond as quickly as possibly by clicking the mouse to stimuli flashed on the screen. Higher scores indicate slower response times and greater number of errors.

    Measured: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)

  6. Fidelity of Intervention Protocol Across Sessions

    Fidelity will be assessed to ensure therapist adherence to the intervention protocol in each session. An adherence measure of covered session topics, covered activities, and global instructor skill in presenting material will be used to for each weekly session. Sessions will be audio recorded and two research assistants will independently rate each item regarding covered session topics and covered activities on a 3-point Likert-style scale ranging from 0-2 (0 = not present, 1 = somewhat present, 2 = fully present), and global instructor skill in presenting the material will also be rated on a 3-point Likert-style scale ranging from 0-2 (0 = none, 1 = minimal, 2 = adequate). Higher scores indicate better fidelity.

    Measured: 6 weeks (i.e., post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2021
  2. Study start16 Feb 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-group design in which eligible participants are randomized via permuted block, with a block size of seven, to either the intervention (CBT-I-F) condition or a no intervention control condition. Unequal allocation to groups based on 60:40 split, intervention:control. Randomization stratified according to gender identity.
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05087121
Sponsor's protocol ID
1684868-2
Status last verified
Sep 2022
First submitted
28 Jun 2021
Last updated
1 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) and Fitbit Inspire HR Wrist Worn Device (NCT04176926) in people with Insomnia and Shift-Work Related Sleep Disturbance, run by Pacific University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Scores on the Pittsburgh Sleep Quality Index (PSQI) (time frame: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05087121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.

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