Enhanced Consent for Symptom Provocation Research
- Conditions
- Trauma
- Interventions
- Behavioral: Enhanced consent procedureBehavioral: Consent as Usual
- Registration Number
- NCT01809899
- Lead Sponsor
- Georgetown University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 12
- nonsmoker
- female
- between 18-55
- experienced trauma
- willing to have a brain scan
- provide consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Consent Procedure Enhanced consent procedure Participants in this group will receive an enhanced consent that will be an hour longer than usual. Consent as Usual Procedure Consent as Usual Participants in this group will receive a normal consent procedure to the study
- Primary Outcome Measures
Name Time Method Blood Oxygen-Level Dependent (BOLD) Signal 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.
- Secondary Outcome Measures
Name Time Method Heart Rate Baseline Heart rate was measured while in the scanner as a secondary psychobiological outcome to be considered in tandem with the BOLD signals from the scanner.