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临床试验/NCT02181569
NCT02181569已完成不适用

Sleep Disturbance and Relapse in Individuals With Alcohol Dependence: An Exploratory Mixed Methods Study

National Institutes of Health Clinical Center (CC)1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2014年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
198
试验地点
1
主要终点
PSQI

研究概览

简要总结

Despite research establishing the relationship between sleep disturbances and alcohol use, there is no clear understanding or model for what occurs once individuals who seek inpatient alcoholism treatment are discharged from rehabilitation facilities and attempt to integrate back into their homes and communities. The purpose of this investigation will be to characterize sleep patterns, perceptions, and beliefs throughout the process of alcohol rehabilitation. The misuse of alcohol is a global public health concern that compromises both individual and societal wellbeing, resulting in an estimated 2.5 million deaths annually. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) distinguishes alcoholism by craving, loss of control, physical dependence, and tolerance (NIAAA, Alcohol Use Disorders). The relationship between alcohol use and sleep disturbances is complex and bidirectional, but sleep disturbances are common among alcoholics during phases of drinking, withdrawal, and abstinence. Outcome expectancies, behavioral capability, and self-efficacy beliefs are central constructs in the Social Cognitive Theory and will be measured directly in this study using both quantitative and qualitative methods. A mixed methods approach will be used to study the following aims: a) to assess individuals' perceptions of and experiences with sleep during alcohol rehabilitation, b) to describe sleep patterns, perceptions, and beliefs among alcohol-dependent individuals throughout the transition from a clinical research facility providing rehabilitation treatment back to the community, c) to assess whether sleep-related beliefs and/or behavior of individuals are predictive of sleep quality or relapse to drinking, and d) to assess whether sleep quality predicts relapse. Adult research participants admitted to the inpatient behavioral health unit and enrolled on to the NIAAA intramural study NCT 0010693: Assessment and Treatment of People with Alcohol Drinking Problems will be recruited for participation in this study (n=215). Sleep quality and duration will be quantitatively assessed approximately one week prior to discharge from the inpatient facility and again 4-6 weeks post-discharge. A sub-set of participants will be asked to wear actiwatches (accelerometers) to provide objective data on sleep throughout the transition from inpatient to outpatient. In addition to quantitative measures, qualitative semi-structured interviews will be conducted with a subset of 25 participants (to reach 25 completed cases) within a week of the scheduled discharge date and again four to six weeks post-discharge to assess perceptions of sleep during recovery. The proposed study will fill a gap in the literature by characterizing sleep throughout the rehabilitation process and ongoing maintenance of abstinence....

详细描述

Despite research establishing the relationship between sleep disturbances and alcohol use, there is no clear understanding or model for what occurs once individuals who seek inpatient alcoholism treatment are discharged from rehabilitation facilities and attempt to integrate back into their homes and communities. The purpose of this investigation will be to characterize sleep patterns, perceptions, and beliefs throughout the process of alcohol rehabilitation. The misuse of alcohol is a global public health concern that compromises both individual and societal wellbeing, resulting in an estimated 2.5 million deaths annually. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) distinguishes alcoholism by craving, loss of control, physical dependence, and tolerance (NIAAA, Alcohol Use Disorders). The relationship between alcohol use and sleep disturbances is complex and bidirectional, but sleep disturbances are common among alcoholics during phases of drinking, withdrawal, and abstinence. Outcome expectancies, behavioral capability, and self-efficacy beliefs are central constructs in the Social Cognitive Theory and will be measured directly in this study using both quantitative and qualitative methods. A mixed methods approach will be used to study the following aims: a) to assess individuals' perceptions of and experiences with sleep during alcohol rehabilitation, b) to describe sleep patterns, perceptions, and beliefs among alcohol-dependent individuals throughout the transition from a clinical research facility providing rehabilitation treatment back to the community, c) to assess whether sleep-related beliefs and/or behavior of individuals are predictive of sleep quality or relapse to drinking, and d) to assess whether sleep quality predicts relapse. Adult research participants admitted to the inpatient behavioral health unit and enrolled on to the NIAAA intramural study NCT 0010693: Assessment and Treatment of People with Alcohol Drinking Problems will be recruited for participation in this study (n=215). Sleep quality and duration will be quantitatively assessed approximately one week prior to discharge from the inpatient facility and again 4-6 weeks post-discharge. A sub-set of participants will be asked to wear actiwatches (accelerometers) to provide objective data on sleep throughout the transition from inpatient to outpatient. In addition to quantitative measures, qualitative semi-structured interviews will be conducted with a subset of 25 participants (to reach 25 completed cases) within a week of the scheduled discharge date and again four to six weeks post-discharge to assess perceptions of sleep during recovery. The proposed study will fill a gap in the literature by characterizing sleep throughout the rehabilitation process and ongoing maintenance of abstinence.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •INCLUSION CRITERIA:
  • •Participants will be eligible for this study if they are:
  • •18 years of age or older,
  • •Enrolled on the screening, assessment and treatment protocol (14-AA-0181)
  • •Have been an inpatient for 21 days or more preceding discharge,
  • •Not enrolled onto a pharmacologic intervention study,
  • •Able to understand the study, and
  • •Willing to return to the Clinical Center 4-6 weeks after being discharged from inpatient treatment for a follow-up visit.

排除标准

  • •Participants will be ineligible for this study if they are:
  • •Less than 18 years of age,
  • •Unable to understand the purpose of the study,
  • •Unable to provide informed consent,
  • •Unable to follow the study design, or
  • •Unable or unwilling to return to the Clinical Center 4-6 weeks after being discharged from inpatient treatment for a follow-up visit.

研究组 & 干预措施

Treatment seeking participants with alcohol dependence

Treatment seeking individuals with alcohol dependence who are admitted into a 28-day inpatient treatment program.

结局指标

主要结局

PSQI

时间窗: Day 2 of inpatient admission, within 7 days of discharge, and 4-6 weeks after discharge

The Pittsburgh Sleep Quality Index (PSQI) is a 19-item, self-rated questionnaire used to measure sleep quality and disturbances over a one-month (30 days) time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global summation score of five or higher is indicative of poor sleep quality (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). The PSQI has been validated in populations with insomnia and other sleep disorders, with psychiatric patients, and in normal populations (Backhaus, Junghanns, Broocks, Riemann, \& Hohagen, 2002; Doi, Minowa, Uchiyama, Okawa, Kim, Shibui, \& Kamei, 2000).

次要结局

  • TLFB(Day 13 and 4-6 weeks after discharge)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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