BioWare to Enhance Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less
研究概览
简要总结
This study examines the ability of an innovative telehealth technology system to enhance Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) talk-therapy for individuals with posttraumatic stress disorder (PTSD) and alcohol use disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female; aged 18-70 years.
- •Able to provide written informed consent.
- •Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder.
- •Meet DSM-5 diagnostic criteria for current PTSD.
- •Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.
排除标准
- •Meet DSM-5 criteria for a history of or current psychotic or bipolar disorders.
- •Current suicidal or homicidal ideation and intent.
- •Psychotropic medications which have been initiated during the past 4 weeks.
- •Acute alcohol withdrawal.
- •Pregnancy or breastfeeding for people of childbearing potential.
- •Currently enrolled in evidence based behavioral treatment for AUD or PTSD.
- •Implanted electronic devices of any kind, including pacemakers, electronic infusion pumps, stimulators, defibrillators or similar.
结局指标
主要结局
Percentage of Participants Who Turn on and Off Equipment in 5 Minutes or Less
时间窗: In-Session Visit (approximately 1 week from baseline)
Feasibility is 80% of participants turning on and off equipment in 5 minutes or less
System Usability Scale
时间窗: Week 12
The System Usability Scale measures how usable and acceptable a product is. This scale ranges from 0-100 with higher scores being indicative of greater usability/acceptability. A mean score of 68 or greater is considered acceptable.
次要结局
未报告次要终点
研究者
Amber Jarnecke
Research Assistant Professor
Medical University of South Carolina