Sleep Disturbance and Relapse in Individuals With Alcohol Dependence: An Exploratory Mixed Methods Study
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|ClinicalTrials.gov Identifier: NCT02181569|
Recruitment Status : Completed
First Posted : July 4, 2014
Last Update Posted : July 7, 2022
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||198 participants|
|Official Title:||Sleep Disturbance and Relapse in Individuals With Alcohol Dependence: An Exploratory Mixed Methods Study|
|Actual Study Start Date :||July 10, 2014|
|Actual Primary Completion Date :||March 4, 2019|
|Actual Study Completion Date :||March 4, 2019|
Treatment seeking participants with alcohol dependence
Treatment seeking individuals with alcohol dependence who are admitted into a 28-day inpatient treatment program.
- PSQI [ Time Frame: Day 2 of inpatient admission, within 7 days of discharge, and 4-6 weeks after discharge ]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).
- TLFB [ Time Frame: Day 13 and 4-6 weeks after discharge ]The TLFB collects drinking information using personal historical events recounted over a fixed time period (Sobell & Sobell, 1992). It is a standard assessment for measuring alcohol drinking patterns and quantification in treatment programs. The number of items corresponds to the number of days of interest, typically 90, which usually takes about 30 minutes to complete.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181569
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Gwenyth R Wallen, Ph.D.||National Institutes of Health Clinical Center (CC)|