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The goal of this single-arm clinical trial is to better understand the ways in which individuals seeking treatment recover from Alcohol Use Disorder (AUD). The main aims are to:
Participants will:
The aim of the current application is to examine the utility and validity of National Institute on Alcohol Abuse and Alcoholism's (NIAAA)new definition of recovery within the context of a novel theoretical model. The proposed study will recruit participants seeking treatment for Alcohol Use Disorder (AUD) from the community. Participants will complete a structured clinical interview and provide information on their current alcohol use and related behaviors. All participants will receive 12 weeks of AUD psychotherapy and complete brief assessments at the end of each treatment session and biweekly during the first 12-months post treatment. In addition, participants will complete in-person interviews at 3-month and 6-month intervals post-treatment for the duration of the study (for up to 24-54 months post treatment depending on time of enrollment). Findings from the proposed research have the potential to increase understanding of the dynamic nature of recovery and thereby improve clinical decision-making and generate future research. Specifically, our goal is to address the question of "Are the constructs of relapse, recurrence remission, or recovery useful heuristics for clinical practice and research, and if so, how?"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Empirical supported psychotherapy for alcohol use disorder (Cognitive-Behavioral Therapy, Motivational Interviewing). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Treatment | Behavioral | 12 sessions of Cognitive-Behavioral Treatment for Alcohol Use Disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heavy Drinking Days (Timeline Follow-back assessment) | Change in self-report percentage of Heavy Drinking Days, completed during interview with a research assistant. | Administered at several timepoints during the study - weekly during treatment (first 3-months), biweekly (1-year following treatment), 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date) |
| Short Inventory of Problems-Alcohol (SIP-A) | Self-report questionnaire that will measure change in negative consequences (e.g., quality of work has suffered due to alcohol, physical health has been harmed due to drinking, family has been hurt due to drinking) associated with alcohol use. Scores range from 0-45, with higher numbers indicating greater negative consequences associated with alcohol use. | Administered at several timepoints during the study - weekly during treatment (first 3-months), biweekly (1-year following treatment), 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date) |
| Alcohol Dependence Scale (ADS) | Self-re[port questionnaire will be used to measure change in the severity of alcohol dependence (e.g., frequency of hangovers, presence of withdrawal symptoms) - Scores range from 0 to 47, with higher scores indicating greater alcohol dependence severity.](streamdown:incomplete-link) | Administered at several timepoints during the study - weekly during treatment (first 3-months), biweekly (1-year following treatment), 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date) |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Quality of Life Scale-BREF (WHOQOL-BREF) | Self-report questionnaire that assesses change in overall quality of life across several domains (e.g., physical, psychological, social, environmental). Scores ranging between 0-100, with higher scores indicating higher quality of life. | Administered at several timepoints during the study - Baseline, End of Treatment, 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33620 | United States |
In compliance with the grant funding agency (NIH/NIAAA, NOT-AA-22-011), participants who give consent will have all their de-identified survey/questionnaire data submitted and shared within the NIAAA Data Archive, which is a data repository housed within the NIMH Data Archive (NDA).
Per NIAAA data sharing policy, there will be a 2-year embargo on data uploaded to the archive (i.e., data will only be shared 2 years after the grant end date on the initial NOA).
Researchers can request de-identified data stored on NIAAA's data archive via submission of a data access request. Researchers (and the institution to which they belong) who requests data must promise to keep data safe and promise not to try to learn the identity of individual study records. Researchers submitting Data Access Requests must be sponsored by an NIH recognized institution (with a FWA) and have a research-related need to access NDA data.
Request includes an NDA Data Use Certification signed by the lead recipient and an authorized Signing Official from the recipient's research institution. Data Access Requests for a given NDA Permission Group are reviewed by an NIH-staffed Data Access Committee.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 12-Item Short-Form Health Survey (SF-12) | Self-report questionnaire measuring change in overall physical and mental health. Scores range from 0-100, with higher scores indicating greater health related problems. | Administered at several timepoints during the study - Baseline, End of Treatment, 3- and 6-month intervals (through completion of study, average between 24-48 months depending on enrollment date) |