Improving PTSD Outcomes in OIF/OEF Returnees: A Randomized Clinical Trial of Hydrocortisone Augmentation of Prolonged Exposure Therapy"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinician Administered PTSD Scale (CAPS)
研究概览
简要总结
This study seeks to examine the efficacy of hydrocortisone administration in the augmentation of the therapeutic effects of Prolonged Exposure (PE) therapy, an empirically tested treatment shown to be effective in the the treatment of posttraumatic stress disorder (PTSD). The augmentation builds on both the translation of neuroscience findings demonstrating the effects of glucocorticoids (GCs) on learning, and on empirical clinical findings from other investigators demonstrating beneficial effects of GCs in reducing traumatic memories in trauma-exposed persons.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 89
- •Capable of understanding, reading, and writing in English
- •OIF/OEF veteran with criterion-A trauma while deployed
- •Minimum PTSD severity of 60 (CAPS)
- •Unmedicated or on a stable psychotropic regimen (i.e., 1 or more months on the same regimen)
排除标准
- •Lifetime history of psychotropic disorder, bipolar disorder, or obsessive compulsive disorder
- •Moderate or severe traumatic brain injury (TBI)
- •A medical or mental health problem other than PTSD that requires immediate clinical attention
- •Substance abuse or dependence within the last 3 months
- •Suicidal risk (as determined by response of 5 or 6 on the suicidality items of the Montgomery-Asberg Depression Rating Scale (MADRS)) and/or assessed suicide risk on the basis of clinical judgment
- •Persons on a psychotropic medication regimen that has not been consistent for one month
- •Presence of diabetes mellitus or any current unstable medical illness or condition that represents a contraindication to taking glucocorticoids (this will be determined by history and/or abnormal laboratory findings at medical clearance)
- •Unwillingness to discontinue other specialized psychotherapy for PTSD during the 11 weeks of study treatment and the 3 month follow-up (Self-help (non-trauma focused) groups or supportive counseling can be continued but not initiated)
- •Pregnant women or those planning to become pregnant within the study period will not be enrolled. Female participants must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide, abstinence) during the course of the study to ensure they do not become pregnant during the course of the study
研究组 & 干预措施
Prolonged Exposure therapy with placebo
干预措施: Prolonged exposure therapy with placebo administration (Other)
Prolonged Exposure therapy with Hydrocortisone
干预措施: Hydrocortisone augmented Prolonged Exposure Therapy (Other)
结局指标
主要结局
Clinician Administered PTSD Scale (CAPS)
时间窗: week 23
Assessment of the severity of PTSD symptoms and of diagnosis of PTSD.
次要结局
- Biological measures associated with PTSD(week 23)
- MATRICS Consensus Cognitive Battery (MCCB)(week 23)
- Other measures of clinical, psychological, and functional outcome(week 23)
研究者
Rachel Yehuda
MHPCCD
Bronx VA Medical Center