A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group
研究概览
简要总结
The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of this study will allow us to see if IPT and ET are equally effective in treating PTSD due to Military Sexual Trauma, with the long-term goal of making PTSD treatment effective for as many people as possible.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •Military Sexual Trauma (MST) survivors, with MST defined as actual or threatened sexual violence, from Vietnam era to current Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn
- •Diagnosed with PTSD consequent to MST, with a minimum CAPS score > 40
- •Medically stable at time of study enrollment (for persons with chronic injuries and that any disability present does not prevent attendance of weekly outpatient therapy sessions)
- •Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
- •Stable on psychotropic medication for the prior 60 days
排除标准
- •Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder
- •Participation in a clinical trial or concurrent evidence-based treatment for MST-related psychiatric conditions or PTSD during the previous 3 months
- •Current evidence of significant unstable medical illness or organic brain impairment such that the patient could not attend sessions regularly or complete assessments
- •Patients who in the investigator's judgment pose a current homicidal or suicidal risk
- •Current or history of substance dependence in the past 90 days.
研究组 & 干预措施
Exposure Therapy
Participants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual.
干预措施: Exposure Therapy (Behavioral)
Interpersonal Psychotherapy
Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.
干预措施: Interpersonal Psychotherapy (Behavioral)
结局指标
主要结局
Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group
时间窗: Baseline, 15 weeks
The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
Difference in mean Clinician Administered PTSD Scale-5 (CAPS-5) score changes between the Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) treatment groups from baseline to post-treatment
时间窗: Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition
The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group
时间窗: Baseline, 11 weeks
The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
次要结局
未报告次要终点