Exploring Mechanisms of Massed Cognitive Processing Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Clinician-Administered PTSD Scale for DSM
研究概览
简要总结
The overall goal of this randomized controlled trial with partial crossover is to compare the effectiveness of 1-week virtual massed Cognitive Processing Therapy (CPT) to 5-day virtual relaxation training (RT) with regard to their ability to reduce posttraumatic stress disorder (PTSD) symptoms. Specifically, this study is designed to 1) examine changes in PTSD symptoms during and following the respective intervention, and 2) explore possible psychological treatment mechanisms, including cognitive control, inhibition, self-efficacy, and memory, and 3) examine possible moderators of treatment success (e.g. neuropsychological factors).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •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
- •Are interested in receiving evidence-based treatment (CPT) for PTSD and able to attend either 10 therapy sessions over the course of one week (5 days) or are interested and able to complete 5 relaxation training sessions over the course of one week (5 days)
- •Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
- •Reside in the state of Illinois during the course of treatment
排除标准
- •The traumatic event occurred in the past month
- •They are currently suicidal or homicidal (i.e., plan and intent)
- •They have unmanaged psychosis or mania
- •They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment
- •They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 3 months or are currently receiving an evidence-based PTSD treatment
- •They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in CPT
- •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 3 months) that would require immediate medical observation if substance use was discontinued (i.e., potential lethality)
- •They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
- •They have a visual or auditory impairment that would prevent them from fully participating in study activities
- •Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect the ability to deliver the intervention with fidelity
研究组 & 干预措施
Cognitive Processing Therapy (CPT)
干预措施: Cognitive Processing Therapy (Behavioral)
Relaxation Training (RT)
干预措施: Relaxation Training (Behavioral)
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM
时间窗: Through study completion, an average of 8 months
Clinician-Administered Assessment of PTSD
PTSD Checklist for DSM-5 Criteria
时间窗: Through study completion, an average of 8 months
Self Report Measure for PTSD
次要结局
未报告次要终点
研究者
Philip Held
Assistant Professor of Psychiatry
Rush University Medical Center