Sleep Health in U.S. Marines
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSan Diego State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Sleep Leadership
BehavioralThis classroom-style educational training was designed by Adler and colleagues (2021) specifically for Army leaders, based on research showing that perceptions of their leader's sleep-related behaviors can impact unit member's sleep (Gunia et al., 2015). The one-hour training includes a combination of PowerPoint slides, video clips, and handouts with content targeting five leader behaviors denoted using the acronym "SLEEP": Set conditions for adequate sleep through work stress mitigation and environmental conditions; Lead by example; Educate Soldiers about caffeine, alcohol, and substances; Encourage awareness and responsibility among Soldiers; Prioritize sleep and recovery during and after missions.
Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program
BehavioralCLASS-MC is a sleep and circadian health-focused educational program originally designed for shipboard Sailors (Schmied et al., 2022) adapted in the current study for Marines. CLASS-MC includes a 30-minute presentation that is delivered in-person. The curriculum includes information on the purpose and benefits of sleep, basic information about circadian health, and detailed and feasible strategies for how to maximize sleep and circadian health in operational conditions.
Insomnia Coach
BehavioralThis 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).
Treatment groups
860 Participants
are divided into 5 treatment groupsGroup A: Group 1Experimental treatment 3 interventions
Group B: Group 2Experimental treatment 2 interventions
Group C: Group 3Experimental treatment 2 interventions
Group D: Group 4Experimental treatment 1 intervention
Group E: Group 5Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Change from baseline to 6-, 12-, and 24-weeks post-baseline2
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.
Time frame
Change from baseline to 6-, 12-, and 24-weeks post-baselineSecondary outcomes
1
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.
Time frame
Change from baseline to 6-, 12-, and 24-weeks post-baseline2
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).
Time frame
Change from baseline to 6-, 12-, and 24-weeks post-baseline3
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).
Time frame
Change from baseline to 6-, 12-, and 24-weeks post-baseline4
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).
Time frame
Change from baseline to 6-, 12-, and 24-weeks post-baselineOther outcomes
1
Health-Related Quality of Life
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).
Time frame
Change from baseline to 6-, 12-, and 24-weeks post-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
San Diego State University
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborator
Palo Alto Veterans Institute for Research
Collaborator
Source ClinicalTrials.gov