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NCT Number: NCT07420205

Sleep Health in U.S. Marines

The goal of this study is to test a sleep health program designed specifically for U.S. Marine Corps personnel. Researchers want to determine if this program helps Marines improve the participants sleep quality and overall mental health. The study will evaluate whether the program improves sleep quality and duration and reduces symptoms of depression, anxiety, PTSD, and suicide ideation. There are three distinct sleep health programs that will be evaluated; participants will be randomly assigned to one of five groups to receive different combinations of the sleep health programs. To measure results, researchers will use participant surveys for all enrolled participants and wearable sleep-tracking devices for a sub-set of participants. The study team expects that Marines who receive the most comprehensive version of the program will show the greatest improvements in sleep and psychological well-being.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Diego State University

San Diego, California, 92182, United States

Location status: Recruiting

Location contact

Emily Schmied

CONTACT

[email protected]

619-594-6317

Emily Schmied

PRINCIPAL_INVESTIGATOR

Maegan Paxton Willing

SUB_INVESTIGATOR

About this study

Purpose/objective: Military suicide remains a pervasive issue, following a sharp increase in the rates of suicidality observed after the start of the Global War on Terror. Given the seriousness of military suicide, suicide prevention is a top priority for the Department of Defense, but interventions that are both effective and feasible to implement across the Force remain elusive, in large part due to challenges in detecting suicidality among personnel who are not enrolled in clinical psychological treatment. As such, interventions that target upstream risk factors for suicide, such as sleep health, may be more effective in combatting this serious issue on a larger scale. Sleep issues are a known predictor of suicidality and are highly prevalent among military personnel. In turn, sleep-focused health promotion interventions have been shown to be feasible to implement in military settings and effective in reducing sleep issues and mitigating psychological symptoms. Thus, there is an urgent need for research focused on the development and evaluation of sleep-focused health promotion interventions adapted for various military contexts. The overarching objective of the present study is to address this need by adapting and evaluating the impact of a multi-level, multi-component sleep health promotion intervention on the psychological health of active duty Marines.

The primary objective of this study is to evaluate the efficacy of a multi-component sleep health promotion intervention among U.S. Marine Corps personnel The proposed study will be guided by the following aims and hypotheses:

Aim 1: Determine the efficacy of a multi-component sleep health intervention for improving sleep quality and psychological health outcomes, including suicidality, among participating Marines. A five-arm trial will be conducted in which participants will be assigned to complete one of three combinations of the sleep health intervention content, or to a delayed intervention comparison group. Sleep, psychological health, and suicidality will be compared between the study groups. Data to be collected to address this aim include survey data and actigraphy data.

Hypothesis 1a: Intervention participants will report significantly better sleep quality and psychological health (reduced symptoms of depression, anxiety, PTSD, and suicidality) compared to participants assigned to the control/delayed intervention group.

Hypothesis 1b: There will be a dose-response relationship between intervention participation and sleep quality and psychological health, such that participants assigned to Intervention Group 1 (all components) will report the greatest improvements followed by Intervention Groups 2 and 3, and lastly, Group 4

Study Methods: The study aims will be achieved through a hybrid type-1 implementation-effectiveness trial (also referred to as 'phase 1' throughout this document) in which an education-based intervention will be evaluated with respect to its impact on sleep and psychological health among participants..

Overview of Methods: The effectiveness of the sleep health intervention will be assessed via a 5-arm trial, in which participants (n = 172 per group; N=860 total) will be assigned to complete various combinations of the intervention (Aim 1). Participants in Group 1 will complete all intervention components. In Group 1 Officers and Senior Enlisted Marines will participate in the one-time Sleep Leadership training, members of the participants Company will participate in the tailored CLASS-MC intervention, and all participants will be asked to use the Insomnia Coach app for 6 weeks. By removing various intervention components in Groups 2, 3, and 4, the design will allow the research team to determine if a certain intervention component leads to greater outcomes, or if greatest outcomes are seen with all components combined (Hypothesis 1b). Group 5 will serve as a delayed treatment comparison group. The intervention effects will be evaluated based on changes in indicators of sleep health and psychological health symptoms, including suicidality.

Description of Interventions: Three existing sleep health promotion interventions will be adapted and implemented in this study, in various combinations. These interventions were selected because each have been implemented in military settings and shown initial evidence of feasibility and efficacy. Further, each targets sleep health from a different perspective, which is important when considering the varied influences on sleep among service members.

  • Sleep Leadership Training: This classroom-style educational training was designed by Adler and colleagues (2021) specifically for Army leaders, based on research showing that perceptions of the participants leader's sleep-related behaviors can impact unit member's sleep. The one-hour training includes a combination of PowerPoint slides, video clips, and handouts with content targeting five leader behaviors denoted using the acronym "SLEEP": Set conditions for adequate sleep through work stress mitigation and environmental conditions; Lead by example; Educate Soldiers about caffeine, alcohol, and substances; Encourage awareness and responsibility among Soldiers; Prioritize sleep and recovery during and after missions. Content will be adapted for Marines.
  • The Circadian, Light, and Sleep Skills in Shipboard Military Personnel (CLASS-SM) Program: CLASS-SM is a sleep and circadian health-focused educational program originally designed for shipboard Sailors that will be adapted for Marines developed by Harrison, Glickman, and colleagues and named "CLASS-MC." CLASS-MC includes a 30-minute presentation that is delivered in person. The curriculum includes information on the purpose and benefits of sleep, basic information about circadian health, and detailed and feasible strategies for how to maximize sleep and circadian health in operational conditions.
  • Insomnia Coach: This intervention is a mobile app developed by researchers at the Department of Veterans Affairs. Insomnia Coach is based on principles of CBT-I, and includes various content modules, such as a daily sleep diary, psychoeducation, and personalized feedback recommendations provided by a feature called "Sleep Coach."

Subjects: Participants in this research study will include up to 860 active duty military personnel. Study inclusion criteria includes: adults 18 years or older; currently serving as an active duty member of the U.S. Marine Corp; currently assigned to duty at the approved study site. Study exclusion criteria includes: 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 post-recruitment). The exclusion criteria were selected to maximize the likelihood that study participants are able to complete all planned study activities during the proposed study timeframe, including attendance at in-person interventions and the completion of assessments that may require access to the internet. No Marines will be excluded based on personal characteristics or medical history.

Assessment: All consenting participants assigned to intervention groups 1-4 will be asked to complete 5 surveys: T1 (baseline/pre-intervention), T2 (immediate post-intervention), T3 (6-week follow-up), T4 (12-week follow-up), T5 (24-week follow-up). Participants assigned to the delayed treatment condition (group 5) will complete all but the T2 survey but will complete all surveys prior to participating in the intervention so that the participants data can serve as comparison data.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18+
  • Able to read and write in English
  • Currently serving as an active duty member of the U.S. Marine Corp
  • Currently assigned to duty at the approved study site

Exclusion criteria

  • 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)
  • Under 18 years of age
  • Unable to read and write in English

Treatment and study plan

Sleep Leadership

Behavioral

This classroom-style educational training was designed by Adler and colleagues (2021) specifically for Army leaders, based on research showing that perceptions of their leader's sleep-related behaviors can impact unit member's sleep (Gunia et al., 2015). The one-hour training includes a combination of PowerPoint slides, video clips, and handouts with content targeting five leader behaviors denoted using the acronym "SLEEP": Set conditions for adequate sleep through work stress mitigation and environmental conditions; Lead by example; Educate Soldiers about caffeine, alcohol, and substances; Encourage awareness and responsibility among Soldiers; Prioritize sleep and recovery during and after missions.

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

Behavioral

CLASS-MC is a sleep and circadian health-focused educational program originally designed for shipboard Sailors (Schmied et al., 2022) adapted in the current study for Marines. CLASS-MC includes a 30-minute presentation that is delivered in-person. The curriculum includes information on the purpose and benefits of sleep, basic information about circadian health, and detailed and feasible strategies for how to maximize sleep and circadian health in operational conditions.

Insomnia Coach

Behavioral

This intervention is a mobile app developed by researchers at the Department of Veterans Affairs (VA; Kuhn et al., 2022). Insomnia Coach is based on principles of CBT-I, and includes various content modules, such as a daily sleep diary, psychoeducation, and personalized feedback recommendations provided by a feature called "Sleep Coach" (Kuhn et al., 2022).

Primary outcomes

  1. Depression symptoms

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    The Patient Health Questionnaire-9 will provide a measure of depressive symptoms. Item scores will be summed to estimate severity of symptoms (range: 0-27).

  2. Sleep Quality

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    The abbreviated Pittsburgh Sleep Quality Index will provide a measure of subjective sleep quality. Items are summed to indicate degree of sleep quality (range: 0-15) with greater scores indicating poorer quality.

Secondary outcomes

  1. Suicide Risk

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    The Columbia-Suicide Severity Rating Scale will be used to provide a measure of suicide risk. C-SSRS does not provide a numerical score but categorizes risk levels based on responses to specific items into low/no, moderate, and high-risk.

  2. Perceived Burdensomeness and Thwarted Belonging

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    The 10-item Interpersonal Needs Questionnaire will provide a measure of Perceived Burdensomeness and Thwarted Belonging. Items averaged with higher scores indicating greater perceived burdensomeness and thwarted belonging (range: 1-7).

  3. Hopelessness

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    Hopelessness will be measured via the abbreviated 4-item Beck Hopelessness Scale. Items are summed with higher scores indicating greater hopelessness (Range 0-4).

  4. Anxiety Symptoms

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    The Generalized Anxiety Disorder 7-item Screener will assess anxiety symptoms. Items are summed with greater scores indicating greater anxiety symptoms (range: 0-21).

  5. Post-traumatic Stress Disorder Symptoms

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    The Primary Care-PTSD Checklist for DSM-5 (PC-PTSD-5 will provide a measure of posttraumatic stress symptoms. Items are summed with greater scores indicating greater PTSD symptoms (range: 0-5).

  6. Insomnia Symptoms

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    Severity of insomnia symptoms will be assessed via the Insomnia Severity Index. Items scores are summed with higher scores indicating greater insomnia severity (range: 0-28).

  7. Sleep Health-Related Knowledge

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    Sleep hygiene behaviors will be measured using a scale developed by members of the proposed research team. A percent correct score is computed.

  8. Sleepiness

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    The Epworth Sleepiness Scale will provide a measure of daytime sleepiness. Items are summed with greater scores indicating greater sleepiness (range: 0-24).

  9. Sleep-promoting behaviors

    Time frame: Change from baseline to 6-, 12-, and 24- weeks post-baseline

    Engagement in sleep-promoting behaviors are assessed through a scale developed by the investigators. Items are summed to compute the number of behaviors used (range: 0-17).

Other outcomes

  1. Health-Related Quality of Life

    Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline

    Quality of life will be measured using an abbreviated version of the World Health Organization Quality of Life-BREF. Mean scores for each domain of functioning are computed with higher scores indicating greater quality of life (range: 1-5).

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Schmied, PhD

CONTACT

[email protected]

619-594-6317

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • Palo Alto Veterans Institute for Research
  • Uniformed Services University of the Health Sciences

Registry information

Official study title

Reducing Suicidality Through Improved Sleep Health

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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