Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	14-CC-0143
Sponsoring Institute	National Institutes of Health Clinical Center (CC)
Recruitment Detail	Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required	Yes
Population Exclusion(s)	Children; Non-English Speaking
Keywords	Addiction Severity Index; Addiction; Sleep Measures; Sleep Disorders; Natural History
Recruitment Keyword(s)	None
Condition(s)	Alcoholism
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	NIH Clinical CenterNational Institute on Alcohol Abuse and Alcoholism

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.

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Eligibility

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.

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Citations:

Not Provided

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Contacts:

Principal Investigator	Referral Contact	For more information:
Gwenyth R. Wallen, Ph.D. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 6-1484 10 Center Drive Bethesda, Maryland 20892 (301) 496-0596 gwallen@cc.nih.gov	Ralph T. Tuason, R.N. National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 2B07B4 10 Center Drive Bethesda, Maryland 20892 (301) 594-2212 ralph.tuason@nih.gov	Office of Patient Recruitment National Institutes of Health Clinical Center (CC) Building 61, 10 Cloister Court Bethesda, Maryland 20892 Toll Free: 1-800-411-1222 Local Phone: 301-451-4383 TTY: TTY Users Dial 7-1-1 ccopr@nih.gov

Clinical Trials Number:

NCT02181569

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