Clinical trial NCT01809899: Enhanced Consent for Symptom Provocation Research
Official title: Risks and Outcomes of Enhanced Consent in Symptom-provocation Research
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Trauma
Keywords: Trauma
Abuse
Domestic Violence
Rape
Assault
MRI
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* nonsmoker
* female
* between 18-55
* experienced trauma
* willing to have a brain scan
* provide consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Blood Oxygen-Level Dependent (BOLD) Signal
timeFrame: Baseline
Secondary outcomes:
measure: Heart Rate
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Georgetown University
name: Mary Ann Dutton, PhD
role: PRINCIPAL_INVESTIGATOR
References: