Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:29 PM
Study NCT ID:
NCT07420205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Health in U.S. Marines
Sponsor:
San Diego State University
Organization:
Study Overview
Official Title:
Reducing Suicidality Through Improved Sleep Health
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
1. 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.
2. 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.
3. 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.
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.
1. 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.
2. 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.
3. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HT9425-24-1-0549 | OTHER_GRANT | Congressionally Directed Medical Research Programs | View |