Sleep Health in U.S. Marines

NCT07420205 | Recruiting Phase 2

• 2 other identifiers: HS20240035HT9425-24-1-0549
• Study Type: interventional
• Target: 860
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Suicidality; Sleep

Keywords

Sleep; Psychological Health; U.S. Military; United States Marine Corps; Suicidality; Sleep Health; Health Promotion

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

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

Secondary Outcomes (9)

• Suicide Risk

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

• Perceived Burdensomeness and Thwarted Belonging

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

• Hopelessness

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

• Anxiety Symptoms

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

• Post-traumatic Stress Disorder Symptoms

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

Other Outcomes (1)

• Health-Related Quality of Life

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

Study Arms (5)

Group 1

EXPERIMENTAL

Leadership education + CLASS-MC + Insomnia Coach App

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

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

Group 3

EXPERIMENTAL

CLASS-MC + Insomnia Coach App

Behavioral: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program; Behavioral: Insomnia Coach

Group 4

EXPERIMENTAL

CLASS-MC

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

Group 5

EXPERIMENTAL

Insomnia Coach App

Behavioral: Insomnia Coach

Interventions

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.

Group 1; Group 2

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.

Group 1; Group 2; Group 3; Group 4

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).

Group 1; Group 3; Group 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• Uniformed Services University of the Health Sciences: collaborator
• Palo Alto Veterans Institute for Research: collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

RECRUITING

Related Publications (15)

• 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.

  PMID: 35473648 BACKGROUND

• 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.

  PMID: 9626712 BACKGROUND

• 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.

  PMID: 1798888 BACKGROUND

• 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.

  PMID: 33119375 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 17845122 BACKGROUND

• 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.

  PMID: 27170304 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 23756722 BACKGROUND

• 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.

  PMID: 20715022 BACKGROUND

• 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.

  PMID: 11438246 BACKGROUND

• 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.

  PMID: 36181915 BACKGROUND

• 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.

  PMID: 34750123 BACKGROUND

• 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.

  PMID: 35270786 BACKGROUND

• 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.

  PMID: 35872149 BACKGROUND

MeSH Terms

Conditions

Depression; Suicidal Ideation; Psychological Well-Being

Interventions

Light

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Study Officials

• Emily Schmied, PhD

  eschmied@sdsu.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Schmied, PhD

CONTACT

619-594-6317; eschmied@sdsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)