The Effectiveness of Individualized Imagery Scripts on Sleep, Psychosis, and Suicidality Among Inpatients With Psychosis: A Randomized Control Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility as assessed by coding percentage of use per night (based on duration of physiological measures collected per night divided by hours of sleep)
研究概览
简要总结
The purpose of this study is to see how feasible is the use of compact EEG and paired audio technology to administer sleep interventions for inpatients with psychosis, to see if individuals that receive individualized technology-based sleep interventions experience improvements in sleep quality and to see if individuals that receive individualized technology-based sleep interventions experience improvements in symptomatology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •primary diagnoses of schizophrenia spectrum disorder or mood disorder with psychotic features, as determined by the treatment team or record review
- •capacity to consent to the study as determined by licensed psychologists ( or the primary attending psychiatrist
- •reported sleep dysfunction which will be determined by a subthreshold or more severe score ≥ 8 on the Insomnia Severity Index (ISI), and/or report experiencing nightmares at least once a week.
排除标准
- •primary substance- or medical-induced psychosis
- •intellectual and developmental disabilities
- •neurodegenerative cognitive disorders
- •implanted devices (e.g., Pacemakers)
- •on one-to-one supervision or 15-minute safety checks for suicidality or aggression
- •patients with roommates that are on 15-minute checks to minimize impact on study participants' awakenings
结局指标
主要结局
Feasibility as assessed by coding percentage of use per night (based on duration of physiological measures collected per night divided by hours of sleep)
时间窗: from start of intervention to end of intervention (upto 80 days after baseline )
Feasibility as assessed by percentage of nights used for the duration of the intervention.
时间窗: from start of intervention to end of intervention (upto 80 days after baseline )
Feasibility as assessed by a self-report satisfaction survey, Was It Worth It questionnaire
时间窗: post-intervention(upto 80 days after baseline )
The measure will consist of 7 items rated on a 5-point Likert scale ranging from Strongly Disagree (1) to Strongly Agree (5), for a maximum score of 35,higher number indicating better satisfaction
次要结局
- Improvements in sleep quality as assessed by the Disturbing Dream and Nightmare Severity Index (DDNSI)(From Baseline to about 3 months after baseline)
- Improvements in sleep quality as assessed by the Presleep Arousal Scale (PAS)(From Baseline to about 3 months after baseline)
- Improvements in symptomology as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(From Baseline to about 3 months after baseline)
- Improvements in sleep quality as assessed by the Insomnia Severity Index (ISI)(From Baseline to about 3 months after baseline)
- Improvements in symptomology as assessed by the abbreviated Positive and Negative Syndrome Scale (PANSS- 6)(From Baseline to about 3 months after baseline)
- Improvements in symptomology as assessed by the Perceived Stress Questionnaire (PSQ)(From Baseline to about 3 months after baseline)
- Improvements in symptomology as assessed by the Posttraumatic Checklist for The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5)(From Baseline to about 3 months after baseline)
- Improvements in sleep quality as assessed by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)(From Baseline to about 3 months after baseline)
- Improvements in sleep quality as assessed by the compact electroencephalography (Muse S, Generation 2)(From baseline to end of study (upto 80 days after baseline ))
- Improvements in symptomology as assessed by the Beck Depression Inventory - II(From Baseline to about 3 months after baseline)
研究者
Alia Warner
Associate Warner
The University of Texas Health Science Center, Houston