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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Education Control Group | Active Comparator | The Sleep Education Control Arm will be provided basic Sleep Education materials that are Standard of Care and available to all Firefighters. |
|
| Sleep Well Intervention Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep enhancement intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment capability | Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month) | From Baseline through Study Completion (12 weeks). |
| Intervention Fidelity | Fidelity: The extent to which an intervention is delivered as intended (target: >80% fidelity score). | 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). | 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. | 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); | 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. | At baseline (week 0) through Study Completion (week 12). |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep, movement, and light exposure | Sleep, circadian rhythm, movement, temperature, and exposure to light will be objectively measuring using the wrist-worn Gene Active | 7 days upon enrollment (Baseline; week 0) and 7 days prior to the end of the intervention (week 12). |
| BMI |
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Inclusion Criteria based on self report:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Selene Y Tobin, PhD | Contact | 805-756-5653 | sytobin@calpoly.edu | |
| Noemi Alacron, MS | Contact | 805-756-5694 | noalarco@calpoly.edu |
| Name | Affiliation | Role |
|---|---|---|
| Suzanne Phelan, PhD | Cal Poly | Principal Investigator |
| Selene Tobin, PhD | Cal Poly | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Polytechnic University - San Luis Obispo | Recruiting | San Luis Obispo | California | 93401 | United States |
De-identified individual participant data will not be made publicly available. Aggregate results will be reported in peer-reviewed publications and scientific presentations.
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| Standard of Care (Investigator Choice) | Behavioral | Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered. |
|
| Adherence |
Logins on the mobile Sleep Well App (Goal: >75% of expected logins on the mobile Sleep Well app) |
| At baseline (week 0) through 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. |
| 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. | 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. | 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. | 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. | At Baseline (week 0) and at Study Completion (week 12). |
| 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. | 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. | 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. | 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. | 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. | Baseline (Week 0) to Post-Intervention (Week 12) |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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