Sequence of Symptom Change During AUD (Alcohol Use or Dependence) or PTSD (Posttraumatic Stress Disorder) Treatment for Comorbid PTSD/AUD
试验速览
- 阶段
- 不适用
- 入组人数
- 235
- 试验地点
- 4
- 主要终点
- Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS)
研究概览
简要总结
The broad, long-term objective of the current research is to improve treatment outcomes for individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and dependence (AUD).
The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP) treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes.
The study will randomize 235 PTSD/AUD participants recruited from the VA and from the community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the AO condition will be re-randomized after the treatment phase to either RP or CPT. Individuals will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and 12-months post-treatment and will monitor symptoms daily throughout treatment.
详细描述
Prior research has established that PTSD and AUD are frequently comorbid.
Although combined treatments have been developed, they are complex and lengthy with mixed results as to their efficacy. Excellent treatments exist for PTSD or AUD alone, however, it has not been adequately addressed to what extent these treatments are effective in treating comorbid symptom presentations. To address this research gap, the investigators will evaluate two widely accepted treatments for each respective disorder; Cognitive Processing Therapy (CPT) an effective PTSD treatment and Relapse Prevention (RP), a widely used effective AUD treatment.
The investigators will build on our prior work using a daily telephone Interactive Voice Response (IVR) system to test models of self-medication and the sequence of symptom change for both primary and secondary symptom targets associated with each therapy.
Creating a more comprehensive model of symptom change in PTSD and alcohol use with widely used selective treatments is critical in testing theories of PTSD/AUD, evaluating these treatments for use with PTSD/AUD, and implementing these therapies with PTSD/AUD patients in standard clinical practice
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age ≥ 18 years with a current DSM-V diagnosis of alcohol abuse/dependence
- •Recent alcohol consumption for at least 2 weeks in the past 30 day period OR at least 2 days of heavy drinking in the past 30 day period
- •Desire to abstain from alcohol
- •Current DSM-V (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of PTSD
- •Capacity to provide informed consent
- •English fluency
排除标准
- •Men and women with an unstable psychiatric medication regimen
- •Current trauma-focused mental health treatment (MH) or behaviorally focused alcohol dependence (AD) AD/MH treatment in the past 30 days
- •Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month
- •Presence of a psychotic disorder or uncontrolled Bipolar Disorder
- •Signs or symptoms of alcohol withdrawal at the time of initial consent
研究组 & 干预措施
Cognitive Processing Therapy (CPT)
干预措施: Cognitive Processing Therapy (CPT) (Behavioral)
Relapse Prevention Therapy (RP)
干预措施: Relapse Prevention (RP) (Behavioral)
Assessment Only (AO)
AO functions as a benchmark comparison condition. Consists of baseline assessment, daily interactive voice response (IVR) monitoring, and immediate post-test assessment. Not an active treatment
结局指标
主要结局
Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS)
时间窗: 12 Months
Reduction in alcohol consumption from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Form-90 (Alcohol Consumption)
时间窗: 12 months
次要结局
- Penn Alcohol Craving Scale (PACS)(Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment)
- Anxiety (GAD-7 & OASIS)(Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment)
- Patient Health Questionnaire Depression Scale (PHQ-9)(Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment)
研究者
Debra Kaysen
Professor
University of Washington