NCT01809899

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 24, 2018

Completed
Last Updated

January 24, 2018

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

August 27, 2009

Results QC Date

February 26, 2016

Last Update Submit

June 20, 2017

Conditions

Trauma

Keywords

TraumaAbuseDomestic ViolenceRapeAssaultMRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Heart Rate

    Baseline

Study Arms (2)

Enhanced Consent Procedure

EXPERIMENTAL

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

Behavioral: Enhanced consent procedure

Consent as Usual Procedure

ACTIVE COMPARATOR

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

Behavioral: Consent as Usual

Interventions

Enhanced consent procedureBEHAVIORAL

Enhanced consent entails a more detailed consent procedure

Enhanced Consent Procedure
Consent as UsualBEHAVIORAL

Routine informed consent procedures

Consent as Usual Procedure

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Consent Forms

Intervention Hierarchy (Ancestors)

Informed ConsentJurisprudenceSocial Control, FormalHealth Care Economics and OrganizationsRecordsOrganization and AdministrationHealth Services AdministrationData CollectionHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Mary Ann Dutton
Organization
Georgetown University Medical Center
mad27@georgetown.edu
2026871997

Study Officials

  • Mary Ann Dutton, PhD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2009

First Posted

March 13, 2013

Study Start

April 1, 2009

Primary Completion

June 1, 2010

Study Completion

August 1, 2014

Last Updated

January 24, 2018

Results First Posted

January 24, 2018

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Data was not valid due to error in data collection technology