Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 主要终点
- Percent Drinking Days (PDD)
研究概览
简要总结
The study has 4 specific aims: (1) To modify our existing Individual Female Specific Cognitive Behavioral Therapy (I-FS-CBT) for Alcohol Use Disorder (AUD) approach to treat women with alcohol dependence in a group format, Group Female Specific Cognitive Behavioral Therapy (G-FS-CBT); (2) To test the relative efficacy of I-FS-CBT and G-FS-CBT; (3) To test hypothesized mechanisms of change in drinking that are common to both treatments, including (a) coping skills and enhanced self-efficacy for abstinence; (b) enhanced sense of autonomy; (c) alleviation of negative affect, and (d) increased social network support for abstinence, and (4) To assess the relative cost-effectiveness of the individual and group treatment.
详细描述
Participants completed a telephone screen for initial eligibility and were scheduled for an in-person clinical intake interview. Consented women were scheduled for a baseline research interview (BL) approximately one week later. At the end of the BL, participants were randomized to treatment condition. During the 12 session treatment period, women completed assessments at the beginning and end of each therapy session on secondary outcome and therapy process variables.
In I-FS-CBT each participant saw a therapist weekly. The first session was 90 minutes long, and subsequent sessions were 60 minutes long. The I-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence and (b) self-care.
The G-FS-CBT manual included material identical to I-FS-CBT, but the session organization was modified for a closed group format. The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material, and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence. The first session of G-FS-CBT was 2 hours; remaining sessions were 90 minutes.
In-person follow-up interviews were done at 3, 9, and 15 months post-session 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18 or older
- •have a current (past year) Diagnostic and Statistical Manual-IV (DSM-IV) alcohol dependence diagnosis
- •used alcohol in the 60 days prior to telephone screening
排除标准
- •have psychotic symptoms in the past six months
- •gross cognitive impairment
- •current physiological dependence on any illicit drug
研究组 & 干预措施
I-FS-CBT
In I-FS-CBT each participant saw a therapist weekly. The first session was 90 minutes long, and subsequent sessions were 60 minutes long. The I-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence, and (b) self-care.
干预措施: I-FS-CBT (Behavioral)
G-FS-CBT
The G-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence, and (b) self-care. The session organization was modified for a closed group format. The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material, and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence.
干预措施: G-FS-CBT (Behavioral)
结局指标
主要结局
Percent Drinking Days (PDD)
时间窗: Change from baseline across 15 months post-session 1
Derived from Timeline Followback (TLFB)
Percent Heavy Drinking Days (PHDD)
时间窗: Change from baseline across 15 months post-session 1
Derived from TLFB; Defined as 4 or more standard drinks per day
Mean Drinks Per Drinking Day (MDPDD)
时间窗: Change from baseline across 15 months post-session 1
Derived from TLFB
次要结局
- Sociotropy-Autonomy Scale(Baseline and through study completion, about 15 months)
- Anxiety(Baseline and through study completion, about 15 months)
- Beck Depression Inventory II(Baseline and through study completion, about 15 months)
- Coping Strategies Scale(Baseline and through study completion, about 15 months)
- Situational Confidence Scale 8(Baseline and through study completion, about 15 months)
- Important People Inventory(Baseline and through study completion, about 15 months)
- Self care(Baseline and through study completion, about 15 months)
- Inventory of Personal Problems(Baseline and through study completion, about 15 months)
- Group Environment Scale Form R(Baseline and through study completion, about 15 months)
研究者
Elizabeth Epstein, Ph.D.
Professor
Rutgers, The State University of New Jersey