Treatment for Excessive Alcohol Use and Depression in Students (TREADS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Daily Drinking Questionnaire
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of 2 different therapy courses for undergraduate college students who binge drink and experience depressive symptoms.
详细描述
After a screening visit (2 ½ hrs) to confirm eligibility for the study, all participants will receive 8 weekly, 1-hour, individual sessions therapy with a counselor. Participants will be randomly assigned, by chance, like the flip of a coin, to the therapy course they will attend. In one of the therapy courses, students are asked questions about their drinking and receive personalized feedback about it, and are taught coping skills for their depressive symptoms. In the second course, students are also taught coping skills for their depressive symptoms but they may or may not talk about alcohol consumption depending on the students' preference. So, both courses teach the same coping skills for depressive symptoms but include different levels of focus on alcohol.
Participants will also complete 2 follow-up visits, at the end of the 8 sessions and then again 4 weeks after completing treatment. These will involve filling out some questionnaires and completing a few neuropsychological tests (these questionnaires and neuropsychological tests will also be completed during the screening visit).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently enrolled in college as an undergraduate student.
- •Ages 18-24 years (inclusive).
- •Presence of two binge drinking episodes in the past month (defined as consumption of 5 or more drinks in 2 hours for males and 4 for females; NIAAA, 2004).
- •BDI-II 12 (12 is often used to indicate the presence of at least mild depressive symptoms) and <30 (indicating severe depression).
排除标准
- •Meeting criteria for substance dependence or abuse (any substance) in the past six months (students with alcohol abuse will not be excluded).
- •Diagnosis of bulimia, psychosis, or bipolar disorder.
- •Having received any psychosocial treatment for depression or substance abuse in the past month.
- •Having received CBT for depression and/or alcohol use in the previous 6 months.
- •If receiving pharmacological treatment for depression or substance abuse, has not been on a stable dose for at least 4 weeks.
- •Discontinued an antidepressant medication less than 1 month ago.
- •Meeting criteria for severe depression or posing a serious suicide or homicide risk.
结局指标
主要结局
Daily Drinking Questionnaire
时间窗: 8 weeks
A measure assessing how much one drinks in a typical week
次要结局
- Beck Depression Inventory(8 weeks)
研究者
Paola Pedrelli
Director of Dual Diagnoses Studies, Depression Clinical and Research Program
Massachusetts General Hospital