Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change from baseline in PTSD symptom severity
研究概览
简要总结
This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment.
详细描述
This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment. Individuals between the ages of 18-65 with chronic PTSD are randomly assigned to one of three psychotherapy conditions: (a) brief enhanced exposure therapy; (b) standard prolonged exposure therapy; and (c) delayed standard exposure therapy. All study participants undergo a phone and face-to-face screening assessment to determine study eligibility and baseline (pretreatment-Week 0) symptom severity. Upon completing treatment, participants undergo three additional assessment visits (Week 6, Week 10, and Week 22). During each of these outcome assessment visits, participants complete a structured clinical interview and a battery of computer-administered questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.
- •Between the age of 18 and
- •Medication status stable for at least 6 weeks
排除标准
- •Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
- •Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
- •Current diagnosis of alcohol or substance dependence within the 3 previous months.
- •Unwilling or unable to discontinue current trauma-focused psychotherapy.
- •Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
- •Other severe acute or chronic medical or psychiatric condition that, in the judgment of the Medical Director, would make the participant inappropriate for entry.
研究组 & 干预措施
Brief Enhanaced Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting the Trauma memories
- Processing the trauma memories
- In vivo Exposure homework
- *Use of a brief pre-exposure trauma memory retrieval trial
- Exposure to video clips related to the patient's trauma
- Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
干预措施: Revisiting the Trauma memories (Behavioral)
Brief Enhanaced Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting the Trauma memories
- Processing the trauma memories
- In vivo Exposure homework
- *Use of a brief pre-exposure trauma memory retrieval trial
- Exposure to video clips related to the patient's trauma
- Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
干预措施: Processing the trauma memories (Behavioral)
Brief Enhanaced Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting the Trauma memories
- Processing the trauma memories
- In vivo Exposure homework
- *Use of a brief pre-exposure trauma memory retrieval trial
- Exposure to video clips related to the patient's trauma
- Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
干预措施: Psychoeducation (Behavioral)
Brief Enhanaced Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting the Trauma memories
- Processing the trauma memories
- In vivo Exposure homework
- *Use of a brief pre-exposure trauma memory retrieval trial
- Exposure to video clips related to the patient's trauma
- Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
干预措施: Trauma Memory Retrieval Trial (Behavioral)
Brief Enhanaced Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting the Trauma memories
- Processing the trauma memories
- In vivo Exposure homework
- *Use of a brief pre-exposure trauma memory retrieval trial
- Exposure to video clips related to the patient's trauma
- Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
干预措施: Exposure to video clips related to the patient's trauma (Behavioral)
Brief Enhanaced Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting the Trauma memories
- Processing the trauma memories
- In vivo Exposure homework
- *Use of a brief pre-exposure trauma memory retrieval trial
- Exposure to video clips related to the patient's trauma
- Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
干预措施: Exposure Homework (Behavioral)
Brief Enhanaced Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting the Trauma memories
- Processing the trauma memories
- In vivo Exposure homework
- *Use of a brief pre-exposure trauma memory retrieval trial
- Exposure to video clips related to the patient's trauma
- Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
干预措施: Compound extinction (Behavioral)
Standard Prolonged Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting of the Trauma memories
- Processing the trauma memories
- Breathing retraining
- In vivo Exposure homework
干预措施: Revisiting the Trauma memories (Behavioral)
Standard Prolonged Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting of the Trauma memories
- Processing the trauma memories
- Breathing retraining
- In vivo Exposure homework
干预措施: Processing the trauma memories (Behavioral)
Standard Prolonged Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting of the Trauma memories
- Processing the trauma memories
- Breathing retraining
- In vivo Exposure homework
干预措施: Psychoeducation (Behavioral)
Standard Prolonged Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting of the Trauma memories
- Processing the trauma memories
- Breathing retraining
- In vivo Exposure homework
干预措施: Breathing retraining (Behavioral)
Standard Prolonged Exposure Therapy
The following interventions are included in this arm:
- Psycho-education addressing common reactions to trauma
- Revisiting of the Trauma memories
- Processing the trauma memories
- Breathing retraining
- In vivo Exposure homework
干预措施: Exposure Homework (Behavioral)
Delayed Treatment Control
Patients assigned to this arm receive assessment only (Week 0, 3, and 6) prior to receiving standard prolonged exposure therapy using the Foa et al treatment manual.
结局指标
主要结局
Change from baseline in PTSD symptom severity
时间窗: Weeks 6, 10, 22
PTSD Symptom Scale - Interview Version
次要结局
- Change from baseline in trauma-related cognitions(Weeks 6, 10, 22.)
- Change from baseline in work, social/leisure activities, and family/home life functioning(Weeks 6, 10, 22.)
- Change from baseline in general physical and psychological health(Weeks 6, 10, 22)
- Change from baseline in depression symptom severity(Weeks 6, 10, 22.)
研究者
Michael J. Telch
Principal Investigator
University of Texas at Austin