Sleep Health, Stress, Anxiety, Physical Activity, Nutrition, Cognition
Conditions
Keywords
Firefighters, Behavioral Sleep Health, Digital Health, Cognition
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALSleep enhancement intervention
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.
BEHAVIORALStandard of Care (Investigator Choice)
Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered.
Sponsors
California Polytechnic State University-San Luis Obispo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
based on self report: * Current CalFire Wildfire firefighter in Central Coast region or City of San Luis Obispo Firefighter (non-volunteer and not a primarily administrator status) * English Speaking * Have an iPhone /iPad * Age \>= 18 * Self-reported interest in improving sleep functioning.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment capability | From Baseline through Study Completion (12 weeks). | Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month) |
| Intervention Fidelity | From Baseline through Study Completion (12 weeks). | Fidelity: The extent to which an intervention is delivered as intended (target: \>80% fidelity score). |
| Intervention Adherence | 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). |
| Acceptability | 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. |
| Retention | 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); |
| Assessment procedures | 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. |
| Adherence | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep, movement, and light exposure | 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 |
| BMI | 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. |
| Depressive symptoms | 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. |
| Caffeine | 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. |
| Anxiety | 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. |
| Stress | 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. |
| Quality of Life | 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. |
| Psychomotor Vigilance | 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. |
| Sleep Diary | 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. |
| Epworth Sleepiness Scale (ESS) Score | 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. |
| Pittsburgh Sleep Quality Index (PSQI) Global Score | 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. |
Countries
United States
Contacts
CONTACTSelene Y Tobin, PhD
CONTACTNoemi Alacron, MS
PRINCIPAL_INVESTIGATORSuzanne Phelan, PhD
Cal Poly
PRINCIPAL_INVESTIGATORSelene Tobin, PhD
Cal Poly
Outcome results
None listed