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

NCT02181569 | Completed

• 2 other identifiers: 14014314-CC-0143
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcoholism

Keywords

Addiction Severity Index; Addiction; Sleep Measures; Sleep Disorders; Natural History

Outcome Measures

Primary Outcomes (1)

• PSQI

  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).

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

Secondary Outcomes (1)

• TLFB

  Day 13 and 4-6 weeks after discharge

Study Arms (1)

Treatment seeking participants with alcohol dependence

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Participants will be eligible for this study if they are:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer J Barb-Smith, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: July 10, 2014
• Primary Completion: March 4, 2019
• Study Completion: March 4, 2019
• Last Updated: April 14, 2026

Record last verified: 2025-11-18

Locations

US (1)