CBT for PTSD in Veterans With Co-Occurring Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 6
- 主要终点
- CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment.
研究概览
简要总结
With this research, the investigators hope to learn if cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD) works in people who have both PTSD and problems with drugs or alcohol. In the past, people who had problems with drugs and alcohol were not given treatment for their PTSD. It was believed that PTSD treatment would get in the way of their drug and alcohol treatment. Now the investigators believe that the PTSD symptoms may make it harder to avoid using drugs and alcohol, so the investigators want to see if people can get treatment for both problems at the same time.
One hundred-sixty Veterans from 3 sites who have both PTSD and substance use disorders will be in the study. In order to know if the PTSD treatment is helpful, half of the Veterans in this study will receive PTSD treatment and half will continue to get their usual mental health and/or substance abuse treatment. Who gets which treatment will be decided by a random process. The investigators will then compare the 2 groups to see if there are differences in their PTSD symptoms.
详细描述
A randomized clinical trial to evaluate the effectiveness of a relatively simple, manual-guided cognitive behavioral therapy (CBT) for PTSD in patients with substance use disorders (SUDs). One hundred sixty outpatients with comorbid PTSD and SUDs from three VA facilities will be randomly assigned to receive either CBT for PTSD in conjunction with standard treatment as usual (TAU) (n = 80) or TAU only (n = 80).
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
- •At least age
- •Current SUD diagnosis.
- •Score of at least 45 on CAPS.
- •Must speak English.
- •Must agree to be taped.
排除标准
- •Acute psychotic symptoms, if not well connected with appropriate mental health services.
- •Severe suicidality.
- •Individuals with unstable medical or legal situations that would make completion of the study highly unlikely.
结局指标
主要结局
CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment.
时间窗: Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up
PTSD symptom severity will be measured by the Clinician Administered PTSD Scale (CAPS). The Clinician Administered PTSD SCALE (CAPS) is the gold standard in PTSD assessment. It is a structured interview that can be used to: Make current (past month) diagnosis of PTSD and Make lifetime diagnosis of PTSD. The minimum value is a 0 and the maximum is 135, the higher the score the worse the outcome, i.e. the more severe PTSD.
次要结局
- PTSD Checklist (PCL)(Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months)
- Addiction Severity Index (Alcohol Addiction)(Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months)
- Addiction Severity Index (Drug Use)(Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months)