Enhanced Consent for Symptom Provocation Research

Study Overview
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Brief Summary
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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
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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.

Official Title
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Risks and Outcomes of Enhanced Consent in Symptom-provocation Research

Conditions
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Trauma

Intervention / Treatment
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* Behavioral: Enhanced consent procedure
* Behavioral: Consent as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Consent Procedure<br>Participants in this group will receive an enhanced consent that will be an hour longer than usual. | Behavioral: Enhanced consent procedure<br>* Enhanced consent entails a more detailed consent procedure<br>|
| Active Comparator: Consent as Usual Procedure<br>Participants in this group will receive a normal consent procedure to the study | Behavioral: Consent as Usual<br>* Routine informed consent procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Oxygen-Level Dependent (BOLD) Signal | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assault, Trauma, Abuse, Domestic Violence, Rape, MRI