Validation of the Insomnia Severity Index as an outcome measure for insomnia research.
C H. Bastien, A Vallières, C M. Morin
https://pubmed.ncbi.nlm.nih.gov/11438246/Actively Recruiting
Led by San Diego State University · Updated on 2026-04-16
860
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating a sleep health program designed specifically for U.S. Marine Corps personnel to see if it can improve sleep quality, duration, and overall mental health. The study focuses on whether the program can reduce symptoms of depression, anxiety, PTSD, suicidality, and suicide ideation. This research addresses the urgent need for effective sleep-focused interventions in military settings, as poor sleep is a known risk factor for suicide and psychological distress among service members. The study involves five groups of participants who will receive different combinations of three sleep health programs Sleep Leadership training for officers and senior enlisted Marines, the CLASS-MC educational program adapted for Marines, and the Insomnia Coach mobile app based on cognitive behavioral therapy for insomnia. Group 1 receives all components, while Groups 2, 3, and 4 receive various combinations, and Group 5 serves as a delayed treatment comparison. The interventions include classroom sessions, in-person presentations, and app-based activities delivered over several weeks. Participants will complete surveys at baseline, immediately post-intervention, and at 6, 12, and 24 weeks after starting the study. A subset will also use wearable sleep-tracking devices to monitor sleep patterns. Researchers will measure changes in sleep quality, depression symptoms, anxiety, PTSD symptoms, suicidality, and other sleep-related behaviors. The study lasts about 24 weeks per participant, with assessments to track psychological and sleep health improvements over time.
CONDITIONS
Sleep Health in U.S. Marines
E
Emily Schmied, PhD
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San Diego State University
Lead Sponsor
Uniformed Services University of the Health Sciences
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Sleep Leadership Training | Circadian, Light, and Sleep Skills (CLASS-MC) | Insomnia Coach Mobile App | Other Behavioral Sleep Arms | Current Evidence-Based Sleep Education/Digital Sleep Treatments |
|---|---|---|---|---|---|
| What it is | A classroom-based educational program for military leaders focusing on modeling and encouraging healthy sleep behaviors within units. | An in-person sleep and circadian health education program adapted for Marines, teaching strategies for improving sleep quality and circadian health. | A mobile app intervention based on cognitive behavioral therapy for insomnia, offering self-guided modules, sleep diary, and tailored feedback. | Additional behavioral sleep interventions delivered in separate experimental arms, each designed to target sleep health in Marines via education or digital tools. | Evidence-based sleep education programs and digital CBT-I treatments, including smartphone apps, used in military and general adult populations for improving sleep quality and reducing insomnia symptoms. |
| Primary use | Used to educate military leaders to foster sleep-supportive environments and improve sleep habits among service members. | Provides service members with practical strategies to manage sleep and circadian health in operational deployments. | Delivers digital CBT-I techniques for self-guided management of insomnia and sleep disturbances. | Applied to improve sleep health and related psychological outcomes among Marines using behavioral or digital sleep strategies. | Used to educate, empower, and treat sleep disturbances and insomnia in military and civilian populations, aiming to improve sleep quality, reduce insomnia symptoms, and support psychological health. |
| Evidence status | Currently under evaluation as an experimental sleep health intervention in Marines; real-world evidence is limited. | Supported by published evidence of efficacy in shipboard military populations and now under experimental evaluation in Marines. | Supported by pilot randomized controlled trial showing feasibility and improvements in insomnia symptoms using digital CBT-I. | Experimental arms; outcome evidence is not yet published for these behavioral interventions in U.S. Marines. | Evidence-based sleep education and digital CBT-I interventions are supported by peer-reviewed trials for improving sleep and psychological health in military and adult populations. |
| Important limitations | Long-term effectiveness and real-world adoption outside research settings are not yet established for Sleep Leadership training. | Although efficacy is supported for shipboard military personnel, effectiveness in ground-based U.S. Marines and sustainability of outcomes await further study. | App-based interventions may face adherence or access barriers; larger studies are needed to confirm efficacy and generalizability. | Outcome evidence for these behavioral sleep arms is not yet available; effectiveness in the target population remains uncertain. | Generalizability from shipboard and civilian studies to active duty U.S. Marines may be limited; digital CBT-I effectiveness may depend on participant engagement. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants complete one or more components of the sleep health promotion intervention, including leadership training, educational presentation, and/or use of a mobile app to improve sleep and psychological health.
1 to 3 in-person or remote intervention activities depending on assigned group
Duration - Up to 24 weeks post-baseline
Participants complete follow-up surveys at multiple timepoints to assess changes in sleep quality, psychological health, and suicidality after the intervention.
5 survey assessments at baseline, immediate post-intervention, 6-, 12-, and 24-weeks follow-up
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
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https://pubmed.ncbi.nlm.nih.gov/16717171/San Diego State University
Lead Sponsor
Uniformed Services University of the Health Sciences
Collaborating Sponsor