DepressionPhase 2NCT07420205
Sleep Health in U.S. Marines
A Phase 2 study testing Sleep Leadership, Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program and Insomnia Coach in people with Depression and Suicidality, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Suicidality, Sleep
- What is being tested?
- Sleep Leadership, Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program and Insomnia Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Diego State University
San Diego, California, 92182
Emily Schmied, 619-594-6317, eschmied@sdsu.edu
Emily Schmied
About this study
Official title: Reducing Suicidality Through Improved Sleep Health
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.
Read the 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.
- 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.
- Conditions
- Depression, Suicidality, Sleep
- Being tested
- Sleep Leadership, Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program, Insomnia Coach
- Keywords
- Sleep, Psychological Health, U.S. Military, United States Marine Corps, Suicidality, Sleep Health, Health Promotion
- Medical subject headings
- Depression, Suicidal Ideation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep LeadershipBehavioural
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 ProgramBehavioural
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 CoachBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Leadership education + CLASS-MC + Insomnia Coach App Receives: Behavioral: Sleep Leadership; Behavioral: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program; Behavioral: Insomnia Coach |
| Group 2 | Experimental | Leadership Education + CLASS-MC Receives: Behavioral: Sleep Leadership; Behavioral: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program |
| Group 3 | Experimental | CLASS-MC + Insomnia Coach App Receives: Behavioral: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program; Behavioral: Insomnia Coach |
| Group 4 | Experimental | CLASS-MC Receives: Behavioral: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program |
| Group 5 | Experimental | Insomnia Coach App Receives: Behavioral: Insomnia Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
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).
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Sleep Quality
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.
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Secondary outcomes (9)
Suicide Risk
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.
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Perceived Burdensomeness and Thwarted Belonging
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).
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Hopelessness
Hopelessness will be measured via the abbreviated 4-item Beck Hopelessness Scale. Items are summed with higher scores indicating greater hopelessness (Range 0-4).
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Anxiety Symptoms
The Generalized Anxiety Disorder 7-item Screener will assess anxiety symptoms. Items are summed with greater scores indicating greater anxiety symptoms (range: 0-21).
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Post-traumatic Stress Disorder Symptoms
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).
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Insomnia Symptoms
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).
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Sleep Health-Related Knowledge
Sleep hygiene behaviors will be measured using a scale developed by members of the proposed research team. A percent correct score is computed.
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Sleepiness
The Epworth Sleepiness Scale will provide a measure of daytime sleepiness. Items are summed with greater scores indicating greater sleepiness (range: 0-24).
Measured: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Sleep-promoting behaviors
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).
Measured: Change from baseline to 6-, 12-, and 24- weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start31 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A five-arm trial will be conducted in which up to 860 (n=172 per group) participants will be assigned to complete one of four combinations of the sleep health intervention content (i.e., sleep education, leadership training to support healthy sleep, Insomnia Coach mobile application) or to a delayed control group. Suicidality, psychological health, and sleep will be compared.
- Masking
- None (open label)
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Palo Alto Veterans Institute for Research
- Responsible party
- Sponsor
- Investigators
- Emily Schmied, PhD, Principal investigator, eschmied@sdsu.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420205
- Sponsor's protocol ID
- HS20240035
- Other IDs
- HT9425-24-1-0549
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuhn E, Miller KE, Puran D, Wielgosz J, YorkWilliams SL, Owen JE, Jaworski BK, Hallenbeck HW, McCaslin SE, Taylor KL. A Pilot Randomized Controlled Trial of the Insomnia Coach Mobile App to Assess Its Feasibility, Acceptability, and Potential Efficacy. Behav Ther. 2022 May;53(3):440-457. doi: 10.1016/j.beth.2021.11.003. Epub 2021 Nov 19.
PubMed 35473648Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
PubMed 9626712Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888Sancho-Domingo C, Carballo JL, Coloma-Carmona A, Buysse DJ. Brief version of the Pittsburgh Sleep Quality Index (B-PSQI) and measurement invariance across gender and age in a population-based sample. Psychol Assess. 2021 Feb;33(2):111-121. doi: 10.1037/pas0000959. Epub 2020 Oct 29.
PubMed 33119375Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Nock MK, Holmberg EB, Photos VI, Michel BD. Self-Injurious Thoughts and Behaviors Interview: development, reliability, and validity in an adolescent sample. Psychol Assess. 2007 Sep;19(3):309-17. doi: 10.1037/1040-3590.19.3.309.
PubMed 17845122Prins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, Kaloupek DG, Schnurr PP, Kaiser AP, Leyva YE, Tiet QQ. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample. J Gen Intern Med. 2016 Oct;31(10):1206-11. doi: 10.1007/s11606-016-3703-5. Epub 2016 May 11.
PubMed 27170304Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Perczel Forintos D, Rozsa S, Pilling J, Kopp M. Proposal for a short version of the Beck Hopelessness Scale based on a national representative survey in Hungary. Community Ment Health J. 2013 Dec;49(6):822-30. doi: 10.1007/s10597-013-9619-1. Epub 2013 Jun 12.
PubMed 23756722Bryan CJ. The clinical utility of a brief measure of perceived burdensomeness and thwarted belongingness for the detection of suicidal military personnel. J Clin Psychol. 2011 Oct;67(10):981-92. doi: 10.1002/jclp.20726. Epub 2010 Aug 16.
PubMed 20715022Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246Chung TH, Hanley K, Le YC, Merchant A, Nascimento F, De Figueiredo JM, Wilcox HC, Coryell WH, Soares JC, Selvaraj S. A validation study of PHQ-9 suicide item with the Columbia Suicide Severity Rating Scale in outpatients with mood disorders at National Network of Depression Centers. J Affect Disord. 2023 Jan 1;320:590-594. doi: 10.1016/j.jad.2022.09.131. Epub 2022 Sep 29.
PubMed 36181915Bryan CJ, Allen MH, Thomsen CJ, May AM, Baker JC, Bryan AO, Harris JA, Cunningham CA, Taylor KB, Wine MD, Young J, Williams S, White K, Smith L, Lawson WC, Hope T, Russell W, Hinkson KD, Cheney T, Arne K. Improving Suicide Risk Screening to Identify the Highest Risk Patients: Results From the PRImary Care Screening Methods (PRISM) Study. Ann Fam Med. 2021 Nov-Dec;19(6):492-498. doi: 10.1370/afm.2729.
PubMed 34750123Harrison EM, Schmied EA, Hurtado SL, Easterling AP, Glickman GL. The Development, Implementation, and Feasibility of a Circadian, Light, and Sleep Skills Program for Shipboard Military Personnel (CLASS-SM). Int J Environ Res Public Health. 2022 Mar 6;19(5):3093. doi: 10.3390/ijerph19053093.
PubMed 35270786Schmied EA, Harrison EM, Easterling AP, Hurtado SL, Glickman GL. Circadian, light, and sleep skills program: Efficacy of a brief educational intervention for improving sleep and psychological health at sea. Sleep Health. 2022 Oct;8(5):542-550. doi: 10.1016/j.sleh.2022.05.010. Epub 2022 Jul 21.
PubMed 35872149
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Suicidality Through Improved Sleep Health
- ClinicalTrials.gov ID
- NCT07420205
- Acronym / sponsor ID
- HS20240035
- Conditions
- Depression, Suicidality, Sleep
- Keywords
- Sleep, Psychological Health, U.S. Military, United States Marine Corps, Suicidality, Sleep Health, Health Promotion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Palo Alto Veterans Institute for Research
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- A five-arm trial will be conducted in which up to 860 (n=172 per group) participants will be assigned to complete one of four combinations of the sleep health intervention content (i.e., sleep education, leadership training to support healthy sleep, Insomnia Coach mobile application) or to a delayed control group. Suicidality, psychological health, and sleep will be compared.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Sleep Leadership, Behavioral: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program, Behavioral: Insomnia CoachLeadership education + CLASS-MC + Insomnia Coach App |
| Group 2 | Experimental | Behavioral: Sleep Leadership, Behavioral: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel ProgramLeadership Education + CLASS-MC |
| Group 3 | Experimental | Behavioral: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program, Behavioral: Insomnia CoachCLASS-MC + Insomnia Coach App |
| Group 4 | Experimental | Behavioral: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel ProgramCLASS-MC |
| Group 5 | Experimental | Behavioral: Insomnia CoachInsomnia Coach App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep LeadershipThis 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. | Behavioural | Group 1, Group 2 |
| Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel ProgramCLASS-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. | Behavioural | Group 1, Group 2, Group 3, Group 4 |
| Insomnia CoachThis 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). | Behavioural | Group 1, Group 3, Group 5 |
Primary outcome
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).
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.
9 secondary outcomes
Suicide Risk
Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Perceived Burdensomeness and Thwarted Belonging
Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Hopelessness
Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Anxiety Symptoms
Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Post-traumatic Stress Disorder Symptoms
Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Insomnia Symptoms
Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Sleep Health-Related Knowledge
Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Sleepiness
Time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline
Sleep-promoting behaviors
Time frame: Change from baseline to 6-, 12-, and 24- weeks post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 35473648Kuhn E, Miller KE, Puran D, Wielgosz J, YorkWilliams SL, Owen JE, Jaworski BK, Hallenbeck HW, McCaslin SE, Taylor KL. A Pilot Randomized Controlled Trial of the Insomnia Coach Mobile App to Assess Its Feasibility, Acceptability, and Potential Efficacy. Behav Ther. 2022 May;53(3):440-457. doi: 10.1016/j.beth.2021.11.003. Epub 2021 Nov 19.
- Background: PubMed 9626712Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
- Background: PubMed 1798888Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Background: PubMed 33119375Sancho-Domingo C, Carballo JL, Coloma-Carmona A, Buysse DJ. Brief version of the Pittsburgh Sleep Quality Index (B-PSQI) and measurement invariance across gender and age in a population-based sample. Psychol Assess. 2021 Feb;33(2):111-121. doi: 10.1037/pas0000959. Epub 2020 Oct 29.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 17845122Nock MK, Holmberg EB, Photos VI, Michel BD. Self-Injurious Thoughts and Behaviors Interview: development, reliability, and validity in an adolescent sample. Psychol Assess. 2007 Sep;19(3):309-17. doi: 10.1037/1040-3590.19.3.309.
- Background: PubMed 27170304Prins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, Kaloupek DG, Schnurr PP, Kaiser AP, Leyva YE, Tiet QQ. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample. J Gen Intern Med. 2016 Oct;31(10):1206-11. doi: 10.1007/s11606-016-3703-5. Epub 2016 May 11.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 23756722Perczel Forintos D, Rozsa S, Pilling J, Kopp M. Proposal for a short version of the Beck Hopelessness Scale based on a national representative survey in Hungary. Community Ment Health J. 2013 Dec;49(6):822-30. doi: 10.1007/s10597-013-9619-1. Epub 2013 Jun 12.
- Background: PubMed 20715022Bryan CJ. The clinical utility of a brief measure of perceived burdensomeness and thwarted belongingness for the detection of suicidal military personnel. J Clin Psychol. 2011 Oct;67(10):981-92. doi: 10.1002/jclp.20726. Epub 2010 Aug 16.
- Background: PubMed 11438246Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Background: PubMed 36181915Chung TH, Hanley K, Le YC, Merchant A, Nascimento F, De Figueiredo JM, Wilcox HC, Coryell WH, Soares JC, Selvaraj S. A validation study of PHQ-9 suicide item with the Columbia Suicide Severity Rating Scale in outpatients with mood disorders at National Network of Depression Centers. J Affect Disord. 2023 Jan 1;320:590-594. doi: 10.1016/j.jad.2022.09.131. Epub 2022 Sep 29.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Schmied, PhD principal investigator
eschmied@sdsu.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sleep Leadership, Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program and Insomnia Coach in people with Depression and Suicidality, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Schmied, PhD (619-594-6317, eschmied@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (time frame: Change from baseline to 6-, 12-, and 24-weeks post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07420205, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.