Clinical trial NCT05087121: A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters
Official title: A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Shift-Work Related Sleep Disturbance
Keywords: Sleep
Firefighter
CBT-I
Lead sponsor: Pacific University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Scores on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
measure: Total Sleep Time Change as Measured by Actigraphy in the Fitbit Inspire HR
timeFrame: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention)
measure: Feasibility as measured by attendance, attrition, and adherence to intervention components.
timeFrame: From intervention Week 1 to intervention Week 6
measure: Acceptability as measured by mean acceptability ratings on four Likert-style questions.
timeFrame: 6 weeks (i.e., post-intervention)
Secondary outcomes:
measure: Depression, Anxiety, and Stress as Measured Through the Depression, Anxiety, and Stress Scales 21 (DASS-21).
timeFrame: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
measure: PTSD as Measured Through the PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
measure: General Health as Measured Through the Medical Outcomes Study 12-item Short-Form Survey (SF12v2)
timeFrame: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
measure: Family Functioning as Measured Through the McMaster Family Assessment Device - General Functioning Scale (FAD-GFS)
timeFrame: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
measure: Vigilant Attention as Measured Through the Psychomotor Vigilance Task (PVT).
timeFrame: Baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
measure: Fidelity of Intervention Protocol Across Sessions
timeFrame: 6 weeks (i.e., post-intervention)
Other outcomes:
Locations:
city: Forest Grove
country: United States
facility: Pacific University
state: Oregon
Study officials:
affiliation: Pacific University
name: Kaylie A Green, M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pacific University
name: Michael Christopher, Ph.D.
role: STUDY_CHAIR
References: