Massed Cognitive Processing Therapy for Combat-related PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
研究概览
简要总结
The purpose of this study is to determine if cognitive processing therapy (CPT) delivered in a massed format (MCPT) is as effective as standard delivery of CPT. MCPT will be delivered in an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual sessions. Standard delivery of CPT consists of 12 sessions over 6 weeks and involves only individual sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment and 1 month and 4 months following treatment in both conditions. Additionally, in order to compare the treatment groups at the same point in actual time, each group will be assessed at the one month posttreatment time point for the other condition.
详细描述
Cognitive Processing Therapy (CPT) is identified as one of the most effective treatments for posttraumatic stress disorder (PTSD) in a wide range of trauma populations, with a higher effect size than any other evidence-based treatments for PTSD. However, CPT has been shown to be somewhat less effective in active duty and veteran populations when compared to civilian trauma victims. One reason may be that service members have difficulty committing to a six-week course of therapy due to the demanding nature of active duty military operations schedules. In addition, limited availability of clinical providers may reduce access to care. One way to address these barriers may be to administer CPT in an intensive, 5-day format. This format may increase rates of treatment completion and produce faster symptom improvement than the standard administration of CPT. This study will test the efficacy of massed CPT (MCPT) compared to standard CPT delivery. MCPT will be delivered in an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual sessions. Standard delivery of CPT consists of 12 sessions over 6 weeks and involves only individual sessions.
The sample includes 140 active duty service members randomized to receive either MCPT or standard CPT. Participants will be assessed 4 times during the course of the study. In order to test the equivalence of the treatment conditions, outcomes will be compared at a consistent number of weeks posttreatment for each condition (e.g., at baseline, and one month and 4 months following the conclusion of the therapy). Additionally, in order to compare the treatment groups at the same point in actual time, each group will be assessed at the one month posttreatment time point for the other condition. The timing of these assessment intervals allows for the comparison groups to be assessed similarly at each important juncture of therapy (baseline and post-treatment) and also to be assessed for maintenance of treatment gains following a similar passage of time (4 months post-treatment). Those who drop out of treatment will be asked to return for the follow-up assessments based on their projected end date for inclusion in the intent to treat analyses.
Aim 1: To evaluate the efficacy of massed CPT in a sample of active duty military in reductions of clinician-rated and self-reported PTSD symptoms, as well as secondary outcomes including depression, psychosocial functioning, and physical health after treatment completion (assessed at one month and 4 months posttreatment for each condition). Rates of treatment completion and speed of recovery will also be compared between conditions.
Aim 2: To examine predictors of symptom reduction in each treatment condition including demographic characteristics, military factors, psychosocial variables, and comorbid mental health symptoms.
Aim 3 (Exploratory): To evaluate the tolerability of massed versus standard administration of CPT. Important nonspecific factors such as therapeutic alliance, patient preference, treatment expectancy, perceived burden, and emotional factors such as anxiety and avoidance will be examined with regard to treatment outcome.
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
- •Adult male or female (age 18+) active duty military seeking treatment for PTSD
- •Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (CAPS-5)
- •Speak and read English
排除标准
- •Current suicide or homicide risk meriting crisis intervention
- •Active psychosis
- •Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires)
结局指标
主要结局
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
时间窗: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)
The CAPS is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study.
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
时间窗: Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment
The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD
次要结局
- Change in suicidality as measured by the Depressive Symptom Index - Suicidality Subscale (DSI-SS)(Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment)
- Changes in functioning as measured by the Well-Being Inventory (WBI)(Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition))
- Changes in alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)(Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition))
- Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment)
- Changes in anger as measured by the Dimensions of Anger Reactions-5 (DAR-5)(Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition))
- Change in sleep disturbance as measured by the Insomnia Severity Index (ISI)(Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition))
- Changes in health functioning as measured by the Veterans Rand 12-Item Health Survey (VR-12)(Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition))
- Change in somatic symptoms as measured by the Patient Health Questionnaire - 15 (PHQ-15)(Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition))
研究者
Jennifer Schuster Wachen, Ph.D.
Principal Investigator
VA Boston Healthcare System
