Sleep Well Firefighters: An App-based Program to Improve Sleep, Cognition, and Behavioral Health in Firefighters

BEHAVIORAL

Sleep 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.

BEHAVIORAL

Standard of Care (Investigator Choice)

Basic Sleep Education materials that are Standard of Care and available to all Firefighters will be administered.

Recruitment capability

Time frame: From Baseline through Study Completion (12 weeks).

Recruitment capability: Number of participants enrolled per month (target of 5 enrolled per month)

Intervention Fidelity

Time frame: From Baseline through Study Completion (12 weeks).

Fidelity: The extent to which an intervention is delivered as intended (target: \>80% fidelity score).

Intervention Adherence

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).

Acceptability

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.

Retention

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);

Assessment procedures

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.

Adherence

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)

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.