Brief Treatment for PTSD: Enhancing Retention and Engagement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Clinician Administered PTSD Scale, 5 (CAPS-5)
研究概览
简要总结
The primary goal of this study is to examine whether a brief treatment approach for PTSD is equally efficacious in the treatment of active duty service members relative to a first line treatment approach that requires much greater treatment dose.
详细描述
The goal of this randomized clinical trial is to investigate if a brief, written intervention for posttraumatic stress disorder (PTSD), Written Exposure Therapy (WET), is non-inferior compared to an evidenced-based behavioral therapy, Cognitive Processing Therapy-Cognition only (CPT-C), in the treatment of PTSD in active duty military men and women with a diagnosis of PTSD who have deployed in support of a post-9/11. The primary study outcome is change in symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 edition (CAPS-5). Independent assessors evaluated participants using the CAPS-5 at baseline, 10-, 20-, and 30-week after the first treatment session.
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
- 是
入选标准
- •Male and female active duty military personnel who have deployed in support of a post-9/11 conflict seeking treatment for PTSD
- •Diagnosis of PTSD
- •Ability to speak, read and write English
- •Not currently engaged in psychosocial treatment for PTSD
- •Individuals taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the first follow-up assessment as much as possible and as medically indicated.
排除标准
- •Current suicide or homicide risk meriting crisis intervention
- •Active psychosis
- •Moderate to severe brain damage
研究组 & 干预措施
Written exposure therapy
5 sessions of imaginal exposure therapy.
干预措施: written exposure therapy (Behavioral)
CPT, cognitive only
12 sessions of cognitive therapy.
干预措施: CPT, cognitive only (Behavioral)
结局指标
主要结局
Clinician Administered PTSD Scale, 5 (CAPS-5)
时间窗: Change from baseline to 10-, 20-, 30-weeks post first treatment session
The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure.
次要结局
未报告次要终点