Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes
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
- 2
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5) Change
研究概览
简要总结
The purpose of this study is to learn whether a mobile health application (mHealth App) for posttraumatic stress disorder (PTSD) with brief support can help individuals who are in treatment for alcohol problems.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years old
- •Currently in addictions treatment
- •Meet criteria for a current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) AUD diagnosis
- •A score of 33 or greater on the PTSD Checklist (PCL-5)
- •Own a smart phone or other type of Wi-Fi-enabled device with App capabilities
排除标准
- •Injection drug use in the past year
- •Patients who are unable to speak and/or understand English
- •Patients who are currently engaged in specific therapy for PTSD (Prolonged Exposure Therapy, Cognitive Reprocessing Therapy, EMDR)
研究组 & 干预措施
PTSD Coach App + Brief Support
PTSD Coach App + Brief Support will include brief instruction and support for the use of the PTSD Coach App developed by the study team. The PTSD Coach App incorporates evidence-based assessment, psychoeducation, and self-management strategies for PTSD symptoms that are customizable to the user.
干预措施: PTSD Coach App + Brief Support (Behavioral)
Enhanced Usual Care (EUC)
EUC will include brief psychoeducation regarding PTSD and alcohol use disorder (AUD) and resources for PTSD-related mental health treatment.
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5) Change
时间窗: Baseline, 1-, 3-, 6-, and 12-months
The PCL-5 is a 20-item, self-reported measure that assesses the 20 DSM-5 symptoms of PTSD. Each symptom is measured on a 0-4 scale, with higher values indicating greater severity. Total scale scores range from 0 to 80.
Timeline Followback (TLFB) for Alcohol Change
时间窗: Baseline, 1-, 3-, 6-, and 12-months
The TLFB assessment method will be used to assess alcohol use in the past 30-days.
次要结局
未报告次要终点
研究者
Kipling Bohnert
Associate Professor
Michigan State University