Cortisol Augmentation of Prolonged Exposure Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in PTSD symptom severity as assessed by the 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans who experienced a criterion A trauma while deployed, and a current diagnosis of PTSD with a minimum of 6 months
- •Capable of understanding, reading and writing English
排除标准
- •Incapable and/or unwilling to provide written informed consent prior to participation
- •Unwilling and/or unable to discontinue current psychotherapy
- •Regular use of psychotropic medication including antidepressants, benzodiazepines, lithium, mood stabilizers, over-the-counter supplements (melatonin, kava-kava, ephedra)
- •Regular use of oral or inhaled steroids
- •Significant illness (e.g., type I or II diabetes requiring the use of insulin, HIV, AIDS, seizure disorder, anemia, Lyme disease, etc.)
- •The veteran, the veteran's physician, or the study physician think that the veteran's clinical state necessitates the prompt initiation of pharmacotherapy or other treatment that would preclude involvement in the study
- •Morbid obesity (VMI > 40)
- •Clinically significant laboratory abnormalities as determine during medical clearance procedures
- •For women, a positive pregnancy test
- •Heavy smoking (more than 2 packs a day)
- •Substance and/or alcohol abuse and/or dependence within the previous 6 months
- •Response of 3 or 4 on the suicidality items of the HDRS or an assessed serious suicide risk
- •Current psychosocial problems that might interfere with treatment compliance
- •A lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, obsessive compulsive disorder or PTSD due to a trauma not sustained in the combat theater
研究组 & 干预措施
1
Prolonged Exposure therapy with Hydrocortisone
干预措施: Prolonged Exposure therapy (Behavioral)
1
Prolonged Exposure therapy with Hydrocortisone
干预措施: Hydrocortisone (Drug)
2
Prolonged Exposure therapy with placebo
干预措施: Prolonged Exposure therapy (Behavioral)
2
Prolonged Exposure therapy with placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change in PTSD symptom severity as assessed by the Clinician Administered PTSD Scale (CAPS)
时间窗: Baseline (Week 0), endpoint (week 11)
次要结局
- Cognitive performance (learning and retention in an episodic memory task, attention and working memory)(Baseline (Week 0), endpoint (week 11))
- Other measures of clinical outcome, psychological state and functioning(Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11))
- Biological measures associated with PTSD severity(Approximately 1 week prior to starting therapy (Week 0) and approximately 1 week after completing 10 weeks of therapy (week 11))