Pilot Trial to Evaluate PROblem Solving Therapy and APPLE Watch for College Students (PRO-APPLE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Alcohol abstinence
研究概览
简要总结
The goals of this Pilot Trial are to test the preliminary efficacy of Problom-Solving Therapy (PST)-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT), vs education only-control to reduce alcohol use disorder symptoms and improve alcohol abstinence.
详细描述
The aims of this study are (1) to test feasibility & acceptability of screening for AUD symptoms/alcohol misuse and recruitment among college students, and (2) to test preliminary efficacy of PST-APPLE Watch in a 2-arm pilot Randomized Control Trial (RCT).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female college students aged 18-25 yr
- •English-speaking
- •Current alcohol use more than or equal to 2 days/week via phone screening
- •Completion of AUDIT screening and meet criteria for (past year) mild, moderate or severe AUD during AUDADIS-5 interview
- •Completion of written informed consent
- •Interested in cutting back alcohol intake or changing his/her drinking
- •Baseline screening study visit
排除标准
- •Participation in past 6 months in AUD or substance use treatment
- •Current use of medications used to treat AUD (e.g., naltrexone)
- •Lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
- •Current use of psychoactive drugs
- •Not currently enrolled in college
- •Not interested in cutting back alcohol intake or changing his/her drinking
- •Pregnancy or intention to become pregnant
研究组 & 干预措施
Treatment group
The intervention group will receive individual PST (60 min individual sessions for 6 weeks, in addition to engaging with APPLE Watch features including fitness tracking (such as regular walks), heart rate, and sleep management on a daily basis. Throughout the final 6 individual self-engaged sessions, participants will persist in engaging and utilizing APPLE Watch features, incorporating daily fitness tracking (such as regular walks), wellness applications, and sleep management and apply PST.
干预措施: PST-APPLE Watch group (Behavioral)
Control group
Participants assigned to Education-only control will be asked to watch "Quit Drinking Motivation," a 20-min video created by the MotivationHub. This video consists of a speech and conversation discussing the negative consequences resulting from their alcohol misuse and the importance of getting sober. The video will be followed by a 30-minute group discussion via zoom.
干预措施: Education-only control group (Behavioral)
结局指标
主要结局
Alcohol abstinence
时间窗: Up to 3 months
Participants will be monitored for 3 months to assess alcohol abstinence by blood alcohol content.
次要结局
- Change in AUD severity at 3 months.(Baseline, 3 months.)
- Change in AUD frequency status.(Baseline, 3 months.)
- Change in Alcohol-related negative consequences at 3 months.(Baseline, 3 months.)
- Change in Alcohol use at 3 months.(Baseline, 3 months.)
- Change in Reasons for drinking at 3 months.(Baseline, 3 months)
- Change in negative affect at 3 months.(Baseline, 3 months)
- Change in positive affect at 3 months.(Baseline, 3 months.)
- Change in Cognitive performance (executive cognitive ability and attention and working memory) at 3 months.(Baseline, 3 months.)
- Change in the quality of life at 3 months.(Baseline, 3 months.)
- Percent heavy drinking days at 3 months.(Baseline, 3 months.)
- Percent binge drinking days at 3 months.(Baseline, 3 months.)
- Percent days abstinence at 3 months.(Baseline, 3 months.)
研究者
Hagar Hallihan
Research Assistant Professor
University of Illinois at Chicago