NCT Number: NCT07477184
The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Luis Obispo, California, 93401, United States
Location status: Recruiting
James Antony, PhD
SUB_INVESTIGATOR
Kelly Bennion, PhD
SUB_INVESTIGATOR
Noemi Alarcon, MS
CONTACT
Sarah Keadle, PhD
SUB_INVESTIGATOR
Selene Tobin, PhD
CONTACT
Selene Tobin, PhD
PRINCIPAL_INVESTIGATOR
Suzanne Phelan, PhD
PRINCIPAL_INVESTIGATOR
The purpose of this pilot study is to examine the feasibility and acceptability of an app-based sleep program designed to help firefighters improve their sleep. This trial will recruit firefighters working on the Central Coast of California. Upon completing screening procedures and an informed consent, participants will be asked to complete questionnaires related to sleep, behavioral health, and cognition and sleep patterns will be objectively assessed using research grade wrist-worn accelerometers. Participants will then be randomized to receive the Sleep Well intervention (mobile iOS app + monthly phone coaching; N=25) or a control condition (handout on sleep in firefighters; N=25). Over a three month study period, participants randomized to the Sleep Well intervention will be asked to 1) track their sleep, physical activity, eating, and stress; 2) complete weekly, in-app learning modules informed by social cognitive theory and cognitive behavioral therapy for insomnia covering topics such as sleep hygiene, bedtime routines, healthy eating and activity patterns, and managing stress; and 3) participate in three monthly coaching phone calls with a trained study interventionist. After the three month study period, all participants will be asked to repeat baseline assessments. Those in the Sleep Well intervention group will also be asked for user feedback. Quantitative data will inform feasibility of digitally delivered, behavioral sleep programming designed for firefighters. Findings will inform intervention strategies targeting healthy sleep behaviors to improve health and cognition in firefighters and guide the study protocol for a full-scale trial
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
based on self report:
Exclusion criteria
The Sleep Well Intervention Group will receive access to a digital Sleep Health App designed for Firefighters and will be asked to participate in monthly coaching phone calls aimed at improving their sleep health.
Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered.
Time frame: From Baseline through Study Completion (12 weeks).
Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month)
Time frame: From Baseline through Study Completion (12 weeks).
Fidelity: The extent to which an intervention is delivered as intended (target: >80% fidelity score).
Time frame: From Baseline (week 0) through Study Completion (12 weeks).
Change in sleep behaviors assessed via in-app tracking (i.e., self-report of sleep behaviors over the study intervention period).
Time frame: At Study Completion (12 weeks).
Participants will be asked to rate the usefulness and satisfaction with app and phone-sessions, using a questionnaire that includes rating scales of various aspects of the program.
Time frame: At Baseline (week 0) through Study Completion (week 12).
Retention: Number of participants who remained in the study throughout the project period of the total number of participants recruited at baseline (Target of 80% retention rate; Reasons for dropout will be collected);
Time frame: At baseline (week 0) through Study Completion (week 12).
Assessment procedures: The extent to which study assessments can be administered as planned; assessment procedures are acceptable to participants; and data collection is complete.
Time frame: At baseline (week 0) through Study completion (week 12).
Logins on the mobile Sleep Well App (Goal: >75% of expected logins on the mobile Sleep Well app)
Time frame: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).
Sleep, circadian rhythm, movement, temperature, and exposure to light will be objectively measuring using the wrist-worn Gene Active
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Weight will be measured using a calibrated digital scale and height using a stadiometer. Self-reported values may be used if direct measurement is not available.
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure of depression severity. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 27, with higher scores indicating greater depressive symptom severity.
Time frame: At Baseline (week 0) and at Study Completion (week 12).
A beverage questionnaire will be administered. Daily caffeine intake will be calculated as average milligrams of caffeine consumed per day.
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Anxiety levels will be assessed using the Beck Anxiety Inventory. The Beck Anxiety Inventory (BAI) is a 21-item self-report measure assessing anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating greater anxiety severity.
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Stress will be measured using the Perceived Stress Scale. The Perceived Stress Scale-10 (PSS-10) is a 10-item self-report measure assessing perceived stress over the past month. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Quality of life will be measured using Short Form Health Survey - SF-12. Scores range from 0 to 100, with higher scores indicating better mental health status.
Time frame: At Baseline (week 0) and at Study Completion (week 12).
Attention will be measured using a psychomotor vigilance task that collects reaction time. The primary metric will be mean reaction time in milliseconds (ms), with higher values indicating slower responses and reduced vigilance.
Time frame: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).
Participants will be asked to complete a log reporting the time they got into bed and got out of bed.
Time frame: Baseline (Week 0) to Post-Intervention (Week 12)
The Epworth Sleepiness Scale (ESS) is an 8-item self-report questionnaire assessing daytime sleepiness. Total scores range from 0 to 24, with higher scores indicating greater daytime sleepiness.
Time frame: Baseline (Week 0) to Post-Intervention (Week 12)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report measure assessing sleep quality. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Contact information is provided by the study sponsor or research team.
Noemi Alacron, MS
CONTACT
Selene Y Tobin, PhD
CONTACT
California Polytechnic State University-San Luis Obispo
Other
Intervention to Improve Sleep, Cognition, and Behavioral Health in Firefighters
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