- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420205
Sleep Health in U.S. Marines
Reducing Suicidality Through Improved Sleep Health
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Emily Schmied, PhD
- Phone Number: 619-594-6317
- Email: eschmied@sdsu.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92182
- Recruiting
- San Diego State University
-
Contact:
- Emily Schmied
- Phone Number: 619-594-6317
- Email: eschmied@sdsu.edu
-
Principal Investigator:
- Emily Schmied
-
Sub-Investigator:
- Maegan Paxton Willing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Leadership education + CLASS-MC + Insomnia Coach App
|
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.
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.
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).
|
|
Experimental: Group 2
Leadership Education + CLASS-MC
|
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.
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.
|
|
Experimental: Group 3
CLASS-MC + Insomnia Coach App
|
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.
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).
|
|
Experimental: Group 4
CLASS-MC
|
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.
|
|
Experimental: Group 5
Insomnia Coach App
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Change from baseline to 6-, 12-, and 24-weeks post-baseline
|
|
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.
|
Change from baseline to 6-, 12-, and 24-weeks post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
|
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).
|
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
|
Hopelessness will be measured via the abbreviated 4-item Beck Hopelessness Scale.
Items are summed with higher scores indicating greater hopelessness (Range 0-4).
|
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
|
The Generalized Anxiety Disorder 7-item Screener will assess anxiety symptoms.
Items are summed with greater scores indicating greater anxiety symptoms (range: 0-21).
|
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
|
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).
|
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
|
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).
|
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
|
Sleep hygiene behaviors will be measured using a scale developed by members of the proposed research team.
A percent correct score is computed.
|
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
|
The Epworth Sleepiness Scale will provide a measure of daytime sleepiness.
Items are summed with greater scores indicating greater sleepiness (range: 0-24).
|
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
|
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).
|
Change from baseline to 6-, 12-, and 24- weeks post-baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Change from baseline to 6-, 12-, and 24-weeks post-baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily Schmied, PhD, eschmied@sdsu.edu
Publications and helpful links
General Publications
- Buysse 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.
- Spitzer 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.
- Development 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.
- Bastien 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.
- Nock 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.
- Johns 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.
- Prins 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.
- Perczel 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.
- 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.
- Sancho-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.
- Bryan 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.
- Chung 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.
- Bryan 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.
- Harrison 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.
- Schmied 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS20240035
- HT9425-24-1-0549 (Other Grant/Funding Number: Congressionally Directed Medical Research Programs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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