Feasibility of Self-Administered Hypnosis for Sleep Quality in Caregivers of Individuals With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Self-Hypnosis Practice Log
研究概览
简要总结
The long-range goal is to identify an efficacious and practical intervention to improve sleep quality and duration for family caregivers of individuals with Alzheimer's disease and related dementias (ADRD). The main goal of this study is to determine feasibility of a self-administered hypnosis intervention with caregivers of individuals with ADRD by randomizing eligible participants into one of two study arms, self-administered hypnosis (treatment group) or sham white noise hypnosis (control group). The investigators are also examining the feasibility of accrual, outcome measures (diaries, actigraphy) and study design.
详细描述
Study Objectives
Aim 1: Determine the accrual, retention, adherence and feasibility, and randomization to the self-administered hypnosis program among caregivers of individuals with ADRD. Feasibility will be determined by (1) drop-out rate, (2) participants' rating of the program, and (3) participants' rating of treatment satisfaction. Adherence will be determined through at-home practice logs. Essential experience on accrual and retention data as well.
Aim 2: Determine feasibility of measures: PSQI, actigraphy recordings, and sleep diaries to assess sleep quality and duration, as well as feasibility of secondary self-report outcome measures of insomnia severity, stress, cognition, and pain among caregivers.
Aim 3: Determine perceptions of hypnosis and potential barriers for the caregiver population and feedback.
Participant Selection and Recruitment Plan
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double
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
- •Active caregiver to an individual with Alzheimer's disease or its related dementias
- •Self-reported sleep duration of 6 or less hours per day/night as indicated on the PSQI
- •Signed informed consent
- •Access to a computer or mobile device with reliable Internet connection that will allow for the completion of study visits and study materials online
排除标准
- •Use of any prescription or over-the-counter therapy for sleep
- •Severe or unstable medical or psychiatric illness
- •Current use of hypnosis for any condition
- •Inability to speak or understand English
结局指标
主要结局
Self-Hypnosis Practice Log
时间窗: Through study completion, an average of 7 weeks
Participants will be instructed in daily practice of hypnosis and asked to keep a daily self-hypnosis practice form during the intervention period.
Daily Sleep Diaries
时间窗: Through study completion, an average of 7 weeks
A daily sleep diary where participants record time awake and time to bed will be used. Participants will be asked to complete a daily sleep diary upon awakening each morning for a week at baseline, daily during the intervention weeks, and a week at follow-up.
Program Rating Scale
时间窗: One week
In order to assess participants' perceptions of the value of the hypnosis program they receive, they will be asked "How do participants rate this hypnosis program overall in regard to ease of use?" and "How do participants rate this hypnosis program overall in regard to improving sleep?" Responses will be given on a 10-point scale ranging from 1 (Poor) to 10 (Excellent) at follow-up.
Treatment Satisfaction Scale
时间窗: One week
Participants will be asked to rate their overall level of satisfaction with the intervention. A 10-point VAS scale anchored with 0 "Completely Dissatisfied" to 10 "Completely Satisfied" will be given at follow-up.
Wrist Actigraphy
时间窗: up to 2 weeks
Wrist actigraphy is a widely used and well-validated measure of sleep duration. Participants will be asked to wear an actigraph (Actiwatch Spectrum Pro), resembling a wrist watch, on their non-dominant wrist. A motion detection device located within the actigraph records movement. After data is collected and stored within the actigraph it can be analyzed with the Actiware software program. This program uses a series of logarithms to measure various factors associated with sleep quality, such as total sleep duration, sleep efficiency, sleep onset latency, and the number of times participants woke during the night. For the present study, participants will be asked to wear the actigraph for one week at baseline and for one week at follow-up.
Pittsburgh Sleep Quality Index
时间窗: up to 2 weeks
Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) during screening and at follow-up to measure sleep quality. The PSQI is a 19-item self-report inventory designed to measure sleep quality. The 19 items are grouped into 7 subscales: 1) sleep quality, 2) sleep efficiency, 3) daytime dysfunction, 4) sleep latency, 5) sleep disturbances, 6) sleep duration, and 7) use of sleep medication. These seven subscales are scored on a scale of 0-3 with higher scores indicating greater sleep pathology. Cronbach's alphas for the PSQI range from .70 to .8024.
Epworth Sleepiness Scale
时间窗: Through study completion, an average of 7 weeks
Participants will be asked to complete the Epworth Sleepiness Scale (ESS) to assess daytime sleepiness. The ESS is an 8-item self-report measure that asks participants to indicate how likely they are to fall asleep while engaging in eight different everyday activities (e.g., watching television, sitting in traffic). Items are scored on a scale from 0-3 with higher scores indicating a greater probability of falling asleep. Previous research indicates that the ESS has a Cronbach's alpha of .8827.
Sleep Environment Questionnaire
时间窗: Through study completion, an average of 7 weeks
Participants will be asked to complete the Sleep Environment Questionnaire during baseline and at follow-up. The Sleep Environment Questionnaire is an 11-item self-report measure that asks about the environment in which a person sleeps. Response options include "True," "False," or "Not Applicable."
Attitudes Toward Hypnosis Scale
时间窗: Through study completion, an average of 7 weeks
The 14-item Attitudes Toward Hypnosis Scale will be used to assess attitudes toward hypnosis at baseline and at follow-up. This scale has shown internal consistency in previous studies, Cronbach's alpha = .8128. A total attitude toward hypnosis score will be calculated for each participant by summing scores across the 14 items with higher scores indicating more positive attitudes toward hypnosis.
次要结局
- Insomnia Severity Index(Through study completion, an average of 7 weeks)
- Perceived Stress Scale(Through study completion, an average of 7 weeks)
- PROMIS Cognitive Function - Short Form(Through study completion, an average of 7 weeks)
- Pain Visual Analog Scale(Through study completion, an average of 7 weeks)
- Motivation Scale(One week during baseline week)
研究者
Gary R. Elkins
Director of Mind-Body Medicine Research Lab
Baylor University