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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
50
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.
California Polytechnic University - San Luis Obispo
San Luis Obispo, California, United States
RECRUITINGRecruitment capability
Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month)
Time frame: From Baseline through Study Completion (12 weeks).
Intervention Fidelity
Fidelity: The extent to which an intervention is delivered as intended (target: \>80% fidelity score).
Time frame: From Baseline through Study Completion (12 weeks).
Intervention Adherence
Change in sleep behaviors assessed via in-app tracking (i.e., self-report of sleep behaviors over the study intervention period).
Time frame: From Baseline (week 0) through Study Completion (12 weeks).
Acceptability
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 Study Completion (12 weeks).
Retention
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
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).
Adherence
Logins on the mobile Sleep Well App (Goal: \>75% of expected logins on the mobile Sleep Well app)
Time frame: At baseline (week 0) through Study completion (week 12).
Sleep, movement, and light exposure
Sleep, circadian rhythm, movement, temperature, and exposure to light will be objectively measuring using the wrist-worn Gene Active
Time frame: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).
BMI
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
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).
Caffeine
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
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
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Quality of Life
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).
Psychomotor Vigilance
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: At Baseline (week 0) and at Study Completion (week 12).
Sleep Diary
Participants will be asked to complete a log reporting the time they got into bed and got out of bed.
Time frame: 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12).
Epworth Sleepiness Scale (ESS) Score
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)
Pittsburgh Sleep Quality Index (PSQI) Global Score
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.
Time frame: Baseline (Week 0) to Post-Intervention (Week 12)