Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- PTSD Symptom Severity-Interview (PSS-I)
研究概览
简要总结
Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a traumatic event and intense, persistent feelings of anxiety. There are several effective therapies for PTSD, but they are often time consuming. The investigators want to see if the investigators can shorten treatment time while keeping therapy effective by adding a medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To examine whether medication plus psychotherapy helps with depression, trauma-related cognitions, and functioning.
详细描述
The psychotherapy the investigators are offering in this study is a type of cognitive behavioral therapy called imaginal exposure. In imaginal exposure, the investigators encourage the client to approach the memory of the trauma by recounting the trauma story to the therapist and discussing his or her reactions to the memory.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
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 65.
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 or psychotropic medication (at least 1 month medication free).
- •Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
- •Unstable cardiovascular, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or hematological disorder or current seizure disorder.
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of active treatment.
- •A history of hypersensitivity or allergy to MB.
- •Any condition possibly affecting drug absorption (e.g., gastrectomy).
- •Glucose-6-phosphate dehydrogenase deficiency.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that, in the judgment of the Medical Directors, would make the participant inappropriate for entry.
研究组 & 干预措施
Psychotherapy plus Methylene Blue, USP
干预措施: Psychotherapy plus Methylene Blue, USP (Drug)
Psychotherapy Plus Placebo
干预措施: Psychotherapy plus Placebo (Behavioral)
Delayed Psychotherapy
干预措施: Delayed Psychotherapy (Behavioral)
结局指标
主要结局
PTSD Symptom Severity-Interview (PSS-I)
时间窗: Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)
PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)
次要结局
未报告次要终点
研究者
Lori Zoellner
Professor, Department of Psychology
University of Washington