860 Participants NeededMy employer runs this trial

Sleep Health Program for Marines

ES
Overseen ByEmily Schmied, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: San Diego State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests various sleep health programs to determine their effectiveness in improving sleep quality and mental health among U.S. Marines. Researchers will examine how these programs impact sleep duration and reduce symptoms of depression, anxiety, PTSD, and suicidal thoughts. Participants will be divided into five groups, each exploring a different combination of sleep improvement strategies, including the Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program, Insomnia Coach, and Sleep Leadership. This trial suits active-duty Marines who can read and write in English and are not scheduled for long deployments or changes in duty stations. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings that could enhance sleep health strategies for Marines.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Circadian, Light, and Sleep Skills (CLASS-MC) program is safe. Studies have found it greatly improves sleep knowledge and health without causing harm. Participants reported better sleep and mental health after a short program, indicating it is well-received.

Trials of the Insomnia Coach app have demonstrated its practicality and popularity among people with insomnia. Veterans using the app reported better sleep and mental health. These results suggest the app is safe and useful for managing insomnia symptoms.

Research highlights the benefits of Sleep Leadership. Leaders who support good sleep can improve sleep health and workplace safety. These studies show no negative effects, indicating it's a safe way to enhance sleep and well-being.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores innovative approaches to improving sleep health for Marines, a group often facing unique sleep challenges. Traditional insomnia treatments typically involve medication or cognitive behavioral therapy, but this trial combines multiple strategies like the Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) program, the Insomnia Coach app, and Sleep Leadership education. These approaches focus on optimizing the natural sleep cycle, offering practical tools for managing insomnia without relying on drugs. By integrating leadership education, the trial also aims to foster a supportive environment for better sleep habits among military personnel. This holistic and non-pharmacological approach could potentially lead to more sustainable and effective sleep solutions in demanding settings.

What evidence suggests that this trial's sleep health programs could be effective for improving sleep and mental health in Marines?

This trial will evaluate different approaches to improving sleep health among Marines. Participants may receive the CLASS-MC program, which studies have shown greatly improves sleep and mental health for military personnel. Others might use the Insomnia Coach app, which research indicates helps users experience better sleep and fewer insomnia symptoms. Some groups will include Sleep Leadership training, which helps leaders encourage better sleep among their teams, potentially boosting overall performance. Overall, these programs have shown promise in enhancing sleep and mental well-being in military settings.12467

Who Is on the Research Team?

ES

Emily Schmied, PhD

Principal Investigator

eschmied@sdsu.edu

Are You a Good Fit for This Trial?

This trial is for active duty U.S. Marines, age 18 or older, who are currently stationed at the study site and can read and write in English. Those under 18, unable to read/write English, or with upcoming long deployments or moves during the study can't join.

Inclusion Criteria

Currently assigned to duty at the approved study site
I am 18 years old or older.
Able to read and write in English
See 1 more

Exclusion Criteria

Unable to read and write in English
I am under 18 years old.
Planned deployment or training operation lasting 30 days or longer and /or planned change of duty station within the study period (i.e., 24 weeks postrecruitment)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive various combinations of sleep health interventions, including Sleep Leadership Training, CLASS-MC, and Insomnia Coach App

6 weeks
In-person and app-based interactions

Follow-up

Participants are monitored for changes in sleep quality and psychological health outcomes, including suicidality

24 weeks
Surveys at 6, 12, and 24 weeks post-baseline

What Are the Treatments Tested in This Trial?

Interventions

  • Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program
  • Insomnia Coach
  • Sleep Leadership

Trial Overview

The study tests three different sleep health programs (Insomnia Coach, Sleep Leadership, CLASS-MC) alone or in combination. Marines are randomly assigned to one of five groups to see which program best improves sleep quality and mental health.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Group 5Experimental Treatment1 Intervention
Group II: Group 4Experimental Treatment1 Intervention
Group III: Group 3Experimental Treatment2 Interventions
Group IV: Group 2Experimental Treatment2 Interventions
Group V: Group 1Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials
182
Recruited
119,000+

Uniformed Services University of the Health Sciences

Collaborator

Trials
130
Recruited
91,100+

Palo Alto Veterans Institute for Research

Collaborator

Trials
58
Recruited
8,800+

Citations

The Development, Implementation, and Feasibility of a ... - PMC

In the present study, a circadian, light, and sleep skills program for shipboard military personnel (CLASS-SM) was designed to encourage and inform strategies ...

Circadian, light, and sleep skills program: Efficacy of a brief ...

A brief 30-min intervention before an underway period improved sleep, circadian, and psychological health outcomes in shipboard sailors, even months later.

Circadian, light, and sleep skills program: Efficacy of a brief ...

A brief 30-min intervention before an underway period improved sleep, circadian, and psychological health outcomes in shipboard sailors, even months later.

Study Details | NCT07420205 | Sleep Health in U.S. Marines

CLASS-MC is a sleep and circadian health-focused educational program originally designed for shipboard Sailors (Schmied et al., 2022) adapted in the current ...

The effects of the Circadian, Light, and Sleep Skills ...

Disrupted sleep and circadian rhythms are linked to myriad health and safety issues that compromise readiness, including negative psychological health outcomes.

Circadian, light, and sleep skills program

In this study, we showed that participation in CLASS-SM—a novel, brief, sleep-focused educational program—significantly improved overall sleep knowledge, sleep- ...

Improving U.S. Navy Shipboard Habitability - DTIC

Sleep and Light. Light and darkness are important factors that can affect circadian timing and therefore sleep. Research by Badia et al. (1991) indicates ...