Enhanced Consent for Symptom Provocation Research

June 20, 2017 updated by: Mary Ann Dutton, PhD, Georgetown University

Risks and Outcomes of Enhanced Consent in Symptom-provocation Research

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Investigators

  • Principal Investigator: Mary Ann Dutton, PhD, Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4295-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data was not valid due to error in data collection technology

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trauma

Clinical Trials on Enhanced consent procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe