Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Alcohol consumption days
研究概览
简要总结
The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting.
This research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current Diagnostic and Statistical Manual (DSM) -5 alcohol use disorder (AUD) based on alcohol symptom checklist
- •An average of 3 or more drinking days per week for the past 30 days
- •Have regular access to a device with video capabilities or a phone to use for study related calls
排除标准
- •Inability to speak or understand English
- •Conditions that preclude informed consent or understanding of assessment or intervention content
- •Past 90-day AUD psychotherapy treatment,
- •At elevated risk for complicated alcohol withdrawal
- •Past-year drug injection.
研究组 & 干预措施
TeleTx intervention
The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing.
干预措施: TeleTx intervention (Behavioral)
Enhanced Usual Care (EUC)
EUC will include brief psychoeducation about AUD and resources for treatment.
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
Alcohol consumption days
时间窗: 12-months
Percent days of alcohol use on the Timeline Follow Back interview
Heavy drinking days
时间窗: 12-months
Percent days heavy drinking on the Timeline Follow Back interview
Alcohol Use Disorder Treatment Initiation
时间窗: 3 months
Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment
Alcohol Use Disorder Treatment Engagement
时间窗: 3 months
Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions
次要结局
- Drinking Risk Levels (Based on World Health Organization Cut-Offs)(Baseline to 12-months)
- World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)(Baseline to 12-months)
- Alcohol consequences(Baseline to 12-months)
- Total Alcohol Use Disorder Psychotherapy Treatment Attendance(12-months)
研究者
Allison Lin
Assistant Professor of Psychiatry
University of Michigan