Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
This study will look at:
How practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment.
The goal is to improve personalized care by:
Identifying factors that might predict how someone will respond to a second treatment.
Creating a simple tool to spot people who might not respond to treatment early, so they can start a different option sooner.
The findings will help improve PTSD care by offering better follow-up treatments and matching patients with the approach that works best for them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Are 18 years or older
- •Are fluent in English
- •Have experienced a Criterion A traumatic event during their lifetime
- •Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
- •Are interested in receiving evidence-based treatment for PTSD and able to attend 10 therapy sessions over the course of 2 weeks (10 days) and could possibly attend another 10 sessions of a subsequent treatment (additional CPT sessions, PE, or STAIR)
- •Are willing and able to complete self-report measures and clinician-rated assessments at multiple timepoints over the course of the study
排除标准
- •The index traumatic event occurred in the past month
- •They are currently suicidal or homicidal (i.e., current plan and imminent intent)
- •They have unmanaged psychosis or mania
- •They have not been on a stable dose of psychotropic medication for at least one month at the time of the baseline assessment
- •They have completed an evidence-based cognitive behavioral PTSD treatment in the past three months or are currently engaged in an evidence-based PTSD treatment (CPT, PE)
- •They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in treatment
- •They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
- •They have an active substance use disorder (within the past three months) that would require immediate medical observation if substance was abruptly discontinued
- •They are involved with current legal actions related to their index trauma
- •They have a visual or auditory impairment that would prevent them from fully participating in study activities
- •They, at the time of consent, appear to have extenuating life circumstances (i.e., unstable housing, no internet access, etc.) which, in the judgement of the study team, could affect the ability to deliver interventions with fidelity
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Baseline to 6 month follow up
A self-report measure of PTSD symptom severity
Clinician Administered PTSD Scale for DSM-5
时间窗: Baseline to 6 mont follow up
A clinician-rated assessment of PTSD
次要结局
未报告次要终点
研究者
Philip Held
Research Director
Rush University Medical Center