Clinical Course of Alcohol Use Disorder Recovery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Heavy Drinking Days (Timeline Follow-back assessment)
研究概览
简要总结
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:
- To establish operational definitions of types of change in relation to National Institute on Alcohol Abuse and Alcoholism's (NIAAA) new definition of recovery, and to distinguish between treatment response, remission versus recovery, and relapse versus recurrence.
- To describe patterns of recovery, including the frequency of within-person transitions between types of change in clinical course to better understand the dynamic nature of recovery.
- To examine the predictive relationships between theoretically important cognitive, behavioral, and affective process variables and changes during recovery, with a focus on how people initiate versus maintain change.
Participants will:
- Receive 12 weeks of psychotherapy for Alcohol Use Disorder
- Complete brief assessments after each treatment session.
- Complete brief assessments bi-weekly via phone for 1-year following treatment.
- Complete in-person interviews at 3 or 6-month intervals post-treatment.
详细描述
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?"
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current diagnosis of AUD (initial screening AUDIT ≥ 8, confirmed with diagnostic interview),
- •live within commuting distance of the program site,
- •provide informed consent.
排除标准
- •acute psychosis or severe cognitive impairment (assessed via Psychotic Module of the M.I.N.I and Mini-Mental State ≤ 23),
- •current drug use diagnosis other than nicotine or marijuana use disorders,
- •lack of sufficient familiarity with the English language to comprehend the recruitment and consent procedures,
- •legally mandated to attend treatment
研究组 & 干预措施
Treatment
Empirical supported psychotherapy for alcohol use disorder (Cognitive-Behavioral Therapy, Motivational Interviewing).
干预措施: Cognitive-Behavioral Treatment (Behavioral)
结局指标
主要结局
Heavy Drinking Days (Timeline Follow-back assessment)
时间窗: 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)
Change in self-report percentage of Heavy Drinking Days, completed during interview with a research assistant.
Short Inventory of Problems-Alcohol (SIP-A)
时间窗: 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)
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.
Alcohol Dependence Scale (ADS)
时间窗: 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)
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.
次要结局
- World Health Organization Quality of Life Scale-BREF (WHOQOL-BREF)(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))
- 12-Item Short-Form Health Survey (SF-12)(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))
研究者
Robert Schlauch
Principal Investigator
University of South Florida