Risks and Outcomes of Enhanced Consent in Symptom-provocation Research
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Blood Oxygen-Level Dependent (BOLD) Signal
研究概览
简要总结
The overall goal of the proposed study is to insure the protection and safety of human subjects who have been previously exposed to interpersonal traumatic events and who are participants in symptom provocation research. The investigators intend to examine trauma history, cognitive, interpersonal, and genetic predictors of participants' unfavorable reaction to participation in research involving trauma-related script-driven imagery (SDI). The design includes comparing participants in a consent as usual group to participants in an enhanced consent group to see which minimizes unfavorable effects of participating in a research provocation study. In addition, the two different consent groups will be assessed for their effects on psychobiological and neurobiological stress response. Furthermore, the investigators will examine the relationship between the psychobiological responses and neural mechanism during SDI, and unfavorable reactions to participation in symptom provocation research.
详细描述
The overall goal of the proposed study is to insure the protection and safety of human subjects who have been previously exposed to interpersonal traumatic events and who are participants in symptom provocation research. The investigators intend to examine trauma history, cognitive, interpersonal, and genetic predictors of participants' unfavorable reaction to participation in research involving trauma-related script-driven imagery (SDI). The design includes comparing participants with and without Posttraumatic Stress Disorder (PTSD) in a consent as usual group to participants in an enhanced consent group to see which group minimizes unfavorable effects of participating in a research provocation study. In addition, the two different consent groups will be assessed for their effects on psychobiological and neurobiological stress response. Furthermore, the investigators will examine the relationship between the psychobiological responses and neural mechanism during SDI, and unfavorable reactions to participation in symptom provocation research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •nonsmoker
- •between 18-55
- •experienced trauma
- •willing to have a brain scan
- •provide consent
排除标准
- •alcohol abuse or dependence
- •bipolar disorder
- •suicidal intent
- •metal in the body or anything else that would interfere with an MRI
- •claustrophobia or inability to lie still for 45 minutes
- •receiving current counseling
- •on certain antidepressants, benzodiazepines, or other psychotropic medication
- •pregnant or nursing
研究组 & 干预措施
Enhanced Consent Procedure
Participants in this group will receive an enhanced consent that will be an hour longer than usual.
干预措施: Enhanced consent procedure (Behavioral)
Consent as Usual Procedure
Participants in this group will receive a normal consent procedure to the study
干预措施: Consent as Usual (Behavioral)
结局指标
主要结局
Blood Oxygen-Level Dependent (BOLD) Signal
时间窗: Baseline
Functional Magnetic Resonance Imaging (fMRI). We were examining differences in Blood Oxygen-Level Dependent (BOLD) signal indicating reaction to a stress-provocation paradigm between the Enhanced Consent and Consent as Usual conditions.
次要结局
- Heart Rate(Baseline)
研究者
Mary Ann Dutton, PhD
Professor
Georgetown University
