Reducing Suicidality Through Improved Sleep Health
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 860
- 试验地点
- 1
- 主要终点
- Depression symptoms
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 3
CLASS-MC + Insomnia Coach App
干预措施: Insomnia Coach (Behavioral)
Group 5
Insomnia Coach App
干预措施: Insomnia Coach (Behavioral)
Group 1
Leadership education + CLASS-MC + Insomnia Coach App
干预措施: Sleep Leadership (Behavioral)
Group 1
Leadership education + CLASS-MC + Insomnia Coach App
干预措施: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program (Behavioral)
Group 1
Leadership education + CLASS-MC + Insomnia Coach App
干预措施: Insomnia Coach (Behavioral)
Group 2
Leadership Education + CLASS-MC
干预措施: Sleep Leadership (Behavioral)
Group 2
Leadership Education + CLASS-MC
干预措施: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program (Behavioral)
Group 3
CLASS-MC + Insomnia Coach App
干预措施: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program (Behavioral)
Group 4
CLASS-MC
干预措施: Circadian, Light, and Sleep Skills in Shipboard Military (CLASS-MC) Personnel Program (Behavioral)
结局指标
主要结局
Depression symptoms
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Insomnia Symptoms(Change from baseline to 6-, 12-, and 24-weeks post-baseline)
- Sleep Health-Related Knowledge(Change from baseline to 6-, 12-, and 24-weeks post-baseline)
- Sleepiness(Change from baseline to 6-, 12-, and 24-weeks post-baseline)
- Sleep-promoting behaviors(Change from baseline to 6-, 12-, and 24- weeks post-baseline)