Insomnia, Cognitive Impairment, and Decision Making Among Patients With Heart Failure:A Randomized Study of Brief Behavioral Treatment for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Sleep quality assessed by the PSQI
研究概览
简要总结
The purpose of this study is to compare a short, behavioral treatment for insomnia with sleep monitoring to determine whether these approaches are effective in reducing insomnia and improving sleep quality among patients with heart failure (HF). This study will also examine the relationship between insomnia and cognitive functioning in HF and the effects of the behavioral treatment on cognitive functioning, self-care, distress, HF symptoms, and functional status.
Participants will be randomly assigned to four-sessions of a behavioral treatment (Brief Behavioral Treatment for Insomnia; BBTI) or sleep monitoring.
详细描述
Comorbid insomnia is prevalent among heart failure (HF) patients and associated with poorer mental and physical functioning, including possible exacerbation of cognitive deficits. Initial investigations document the effectiveness of cognitive-behavioral therapy for the treatment of insomnia in HF. However, the high symptom burden of HF necessitates alternative interventions for these patients with fewer time and physical endurance demands.
Brief Behavioral Treatment for Insomnia (BBTI) is a four-session behavioral intervention that emphasizes stimulus control and sleep restriction techniques, along with providing education to patients about healthy sleep practices and behaviors that adversely affect sleep. The efficacy of BBTI has been previously documented in samples of older adults with insomnia, but the intervention has yet to be applied to a disease-specific patient population.
This study was designed to 1) evaluate the treatment effects of BBTI on insomnia among HF patients, 2) examine the relationship between insomnia, cognitive function, and decision-making in HF patients at baseline, and 3) evaluate the effects of BBTI on relevant correlates of insomnia in HF patients, including cognitive functioning, decision-making, distress, self-care, quality of life, and functional status.
Participants will be randomized to either the four-session behavioral intervention (BBTI) or a sleep monitoring condition. Measures of sleep (insomnia, sleep efficiency, sleep quality), cognitive functioning (memory, attention, executive functioning, and decision making), distress (anxiety and depression), HF-related quality of life, HF self-care, and functional status will be obtained from participants at baseline, post-intervention, and 6 months post-intervention. Repeated measures multivariate analysis of variance (MANOVA) will serve as the primary mode of data analysis.
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
- Single (Outcomes Assessor)
盲法说明
Baseline assessment is completed prior to randomization. Assessments conducted at 2 weeks and 6 months post-intervention are completed by an assessor blinded to participants' assigned condition.
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
- •18 years of age or older
- •Fluent in English
- •Diagnosis of heart failure
- •At least mild chronic insomnia
排除标准
- •Restless legs syndrome
- •Narcolepsy
- •Perform night or rotating shift work
- •Seizure disorder
- •Excessive daytime sleepiness
- •Current or past diagnosis of Bipolar disorder or psychotic disorder
- •Significant cognitive impairments
- •Untreated moderate to severe sleep apnea or high risk for sleep apnea
结局指标
主要结局
Sleep quality assessed by the PSQI
时间窗: Change from pre-intervention to 2 weeks post-intervention
Sleep quality will be measured with the 19-item self-report Pittsburgh Sleep Quality Index (PSQI). Seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction) are derived from the instrument which can then be summed to produce a total 'global' PSQI score ranging from 0 to 21. Total PSQI scores greater than 5 indicate poor sleep quality.
Sleep efficiency
时间窗: Change from pre-intervention to 2 weeks post-intervention
Sleep efficiency (SE) will be measured with two-week sleep diaries where participants log their daily bed and wake times, as well as the number of hours of sleep each night. SE will be calculated as the percentage of sleep time divided by time spent in bed, with higher percentages indicative of more efficient sleep.
Insomnia severity
时间窗: Change from pre-intervention to 2 weeks post-intervention
Insomnia symptoms will be measured with the 7-item self-report Insomnia Severity Index (ISI). This measure assesses the severity of sleep-onset and sleep maintenance difficulties, sleep satisfaction, as well as associated daytime dysfunction and distress over the prior two weeks. Items are answered on a 5-point Likert-scale from 0 'not at all' to 4 'extremely'. Total scores range from 0 to 28, with higher scores reflective of greater insomnia severity. Scores of 8 or greater indicate the presence of at least mild clinical insomnia.
次要结局
- Insomnia severity(Change from pre-intervention to 6 months post-intervention)
- Decision making assessed by the IGT(Pre-intervention)
- Decision making assessed by the MCQ(Change from pre-intervention to 6 months post-intervention)
- Decision making assessed by the GDT(Change from pre-intervention to 6 months post-intervention)
- Depression(Change from pre-intervention to 6 months post-intervention)
- HF self-care(Change from pre-intervention to 6 months post-intervention)
- Sleep efficiency(Change from pre-intervention to 6 months post-intervention)
- Memory(Change from pre-intervention to 6 months post-intervention)
- Anxiety(Change from pre-intervention to 6 months post-intervention)
- Executive function(Change from pre-intervention to 6 months post-intervention)
- Attention and psychomotor performance(Change from pre-intervention to 6 months post-intervention)
- Sleep quality assessed by the PSQI(Change from pre-intervention to 6 months post-intervention)
- HF-related quality of life(Change from pre-intervention to 6 months post-intervention)
- Functional Status(Change from pre-intervention to 6 months post-intervention)
研究者
Charles Emery PhD
Professor
Ohio State University