Comparative Effectiveness Trial of Sleep Promotion vs. Disruption in High Suicide Risk Inpatients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The purpose of this study is to examine effects of sleep promotion versus treatment as usual (TAU) on subjective, self-reported sleep while in inpatient psychiatric treatment, to examine effects of sleep promotion vs. TAU/sleep disruption on self-reported depression, anxiety, suicide risk across inpatient length of stay, readmission at 72 hours, objective sleep and to compare implementation outcomes of acceptability and feasibility of sleep promotion relative to TAU/sleep disruption as reported by patients, clinicians, and clinic leaders using mixed methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted voluntarily to inpatient psychiatric hospital for suicidal ideation or behavior.
- •Continue to express suicide risk on the Suicide Behaviors Questionnaire-Revised (SBQ-R) of ≥8 at admission.
- •Cognitive ability as tested by the Montreal Cognitive Assessment (MoCA) of >
- •Have sufficient communication and comprehension ability to consent to the study
- •English speaking
排除标准
- •Intellectual disability/unable to give informed consent.
- •Patients with one-to-one supervision or 15-minute (Q15) safety checks for suicidality or aggression will be unable to enroll in the study until these restrictions are discontinued.
- •Patients with roommates that are on one-to-one supervision or Q15 safety checks for suicidality or aggression.
- •Patients enrolled in the study with a patient admitted as their roommate who requires one-to-one supervision or Q15 checks-Patient will be unenrolled if a room change is not possible.
研究组 & 干预措施
Sleep promotion
Scented Oil Ear Plugs Eye Mask Video based safety checks will be done as long as participant is asleep. In person safety check will be done once participant is awake
干预措施: Scented Oil (Drug)
Sleep promotion
Scented Oil Ear Plugs Eye Mask Video based safety checks will be done as long as participant is asleep. In person safety check will be done once participant is awake
干预措施: Ear Plugs (Device)
Sleep promotion
Scented Oil Ear Plugs Eye Mask Video based safety checks will be done as long as participant is asleep. In person safety check will be done once participant is awake
干预措施: Eye Mask (Device)
Sleep promotion
Scented Oil Ear Plugs Eye Mask Video based safety checks will be done as long as participant is asleep. In person safety check will be done once participant is awake
干预措施: Video based safety check (Behavioral)
Sleep promotion
Scented Oil Ear Plugs Eye Mask Video based safety checks will be done as long as participant is asleep. In person safety check will be done once participant is awake
干预措施: In person safety check (Behavioral)
Treatment as usual
Only in person safety check will be conducted
干预措施: In person safety check (Behavioral)
结局指标
主要结局
Change in nighttime Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
时间窗: Admission, Discharge (about 2 weeks after admission )
The PSQI has 19 self rated questions with a global score range of 0 to 21.It has 7 components and each is scored from 0 (no difficulty) to 3(severe difficulty) with higher scores indicating poorer sleep quality.
Change in insomnia as assessed by the Insomnia Severity Index (ISI)
时间窗: Admission, Discharge (about 2 weeks after admission )
The ISI is a 7-item , each item is rated on a 0 (no problem)-4 (very severe problem) scale, with total scores ranging from 0 to 28. Higher scores indicate greater insomnia severity.
Change in daytime Sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
时间窗: Admission, Discharge (about 2 weeks after admission )
The ESS is an 8-item questionnaire. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
次要结局
- Change in suicide risk as assessed by the Suicide Behaviors Questionnaire Revised (SBQ-R)(Admission, Discharge (about 2 weeks after admission ))
- Change in Suicide Ideation as assessed by the Beck Scale for Suicide Ideation (BSS)(Admission, Discharge (about 2 weeks after admission ))
- Change in Anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) scale(Admission, Discharge (about 2 weeks after admission ))
- Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)(Admission, Discharge (about 2 weeks after admission ))
- Objective Nighttime Sleep Quantity as assessed by the Total Sleep Time (TST) via ActiGraph wGT3X-BT(Each night during length of stay (about 2 weeks))
- Objective Nighttime Sleep Quality as assessed by the Nighttime Awakenings via ActiGraph wGT3X-BT(Each night during length of stay(about 2 weeks))
研究者
Michelle Patriquin
Associate Professor
The University of Texas Health Science Center, Houston