Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02181569 |
| Other study ID # |
140143 |
| Secondary ID |
14-CC-0143 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2014 |
| Est. completion date |
March 4, 2019 |
Study information
| Verified date |
January 10, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
