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Enhanced Consent for Symptom Provocation Research

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ClinicalTrials.gov Identifier: NCT01809899
Recruitment Status : Terminated (Time and funding ran out prior to full recruitment)
First Posted : March 13, 2013
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Ann Dutton, PhD, 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.

Condition or disease Intervention/treatment Phase
Trauma Behavioral: Enhanced consent procedure Behavioral: Consent as Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Risks and Outcomes of Enhanced Consent in Symptom-provocation Research
Study Start Date : April 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Enhanced Consent Procedure
Participants in this group will receive an enhanced consent that will be an hour longer than usual.
Behavioral: Enhanced consent procedure
Enhanced consent entails a more detailed consent procedure

Active Comparator: Consent as Usual Procedure
Participants in this group will receive a normal consent procedure to the study
Behavioral: Consent as Usual
Routine informed consent procedures




Primary Outcome Measures :
  1. Blood Oxygen-Level Dependent (BOLD) Signal [ Time Frame: 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 :
  1. Heart Rate [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809899


Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Mary Ann Dutton, PhD Georgetown University

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Responsible Party: Mary Ann Dutton, PhD, Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT01809899     History of Changes
Other Study ID Numbers: 4295-033
First Posted: March 13, 2013    Key Record Dates
Results First Posted: January 24, 2018
Last Update Posted: January 24, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data was not valid due to error in data collection technology

Keywords provided by Mary Ann Dutton, PhD, Georgetown University:
Trauma
Abuse
Domestic Violence
Rape
Assault
MRI