Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study 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.


Criteria:

- 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. EXCLUSION CRITERIA: 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.


Study is Available At:


Original ID:

140143


NCT ID:

NCT02181569


Secondary ID:

14-CC-0143


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

198


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gwenyth R Wallen, Ph.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)

Study Dates

Start Date:July 10, 2014
Completion Date:March 4, 2019
Completion Type:Actual
Primary Completion Date:March 4, 2019
Primary Completion Type:Actual
Verification Date:September 27, 2019
Last Changed Date:December 20, 2019
First Received Date:July 2, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:PSQI
Time Frame:Day 2 of inpatient admission, within 7 days of discharge, and 4-6 weeks after dischange
Safety Issues:False
Description: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 quali
Outcome Type:Secondary Outcome
Measure:TLFB
Time Frame:Day 13 and 4-6 weeks after discharge
Safety Issues:False
Description:The TLFB collects drinking information using personal historical events recounted over a fixed time period. It is a standard assessment for measuring alcohol drinking patterns and quantification in treatment programs. The number of items corresponds to th

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Treatment seeking participants with alcohol dependence
Description:Treatment seeking individuals with alcohol dependence who are admitted into a 28-day inpatient treatment program.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institutes of Health Clinical Center (CC)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Samples and Retentions

Study Population: Treatment seeking individuals with alcohol dependence who are admitted into a 28-day inpatient treatment program.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation:Mahfoud Y, Talih F, Streem D, Budur K. Sleep disorders in substance abusers: how common are they? Psychiatry (Edgmont). 2009 Sep;6(9):38-42.
PMID:19855859

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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