Enhanced Consent for Symptom Provocation Research

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-08-31

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.

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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.

Conditions

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Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Enhanced Consent Procedure

Participants in this group will receive an enhanced consent that will be an hour longer than usual.

Group Type EXPERIMENTAL

Enhanced consent procedure

Intervention Type BEHAVIORAL

Enhanced consent entails a more detailed consent procedure

Consent as Usual Procedure

Participants in this group will receive a normal consent procedure to the study

Group Type ACTIVE_COMPARATOR

Consent as Usual

Intervention Type BEHAVIORAL

Routine informed consent procedures

Interventions

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Enhanced consent procedure

Enhanced consent entails a more detailed consent procedure

Intervention Type BEHAVIORAL

Consent as Usual

Routine informed consent procedures

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes