NCT02181569

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

Completed Last updated 14 April 2026

What this trial tests

trial in Alcoholism in 198 participants. Completed in 4 March 2019.

Timeline

10 July 2014

Primary endpoint
4 March 2019

4 March 2019

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	198
Start date	10 July 2014
Primary completion	4 March 2019
Estimated completion	4 March 2019
Sites	1 location across United States

Conditions studied

• Alcoholism — all drugs for Alcoholism →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

18 and older, any sex, with Alcoholism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sleep Disturbances in Individuals with Alcohol-Related Disorders: A Review of Cognitive-Behavioral Therapy for Insomnia (CBT-I) and Associated Non-Pharmacological Therapies.
   Brooks AT, Wallen GR. · · 2014 · cited 27× · PMID 25288884 · DOI 10.4137/sart.s18446