NCT00069212

Brief Summary

This study will evaluate brain changes and psychological characteristics of people who are resilient to trauma. It will examine and compare responses in three categories of subjects: 1) people who have been exposed to a significant traumatic event and suffer symptoms of post-traumatic stress disorder (PTSD) severe enough to interfere with their ability to function; 2) people who have been exposed to a significant traumatic event and do not suffer PTSD symptoms severe enough to interfere with their ability to function; and 3) people who have never been exposed to a significant traumatic event. Most people who are exposed to trauma recover well from the adversity. Some may even benefit from it by, for example, gaining greater self-confidence of strengthening personal relationships. Others, however, develop PTSD and may have repeated thoughts, images, and dreams of the trauma; feel upset when reminded of the traumatic event; avoid places or people that remind them of the trauma; feel detached from others; have difficulty sleeping and concentrating; or startle easily. People in the three categories listed above may be eligible for this study. Candidates will be screened with a medical and psychiatric interview, evaluation of emotional intelligence (sensitivity to feelings of others), physical examination, electrocardiogram (EKG) and blood tests. Participants will undergo the following additional tests and procedures:

  • 24-hour urine collection and three urine drug screens over the course of the study.
  • Saliva collection every 2 hours on the day of the urine collection.
  • Magnetic resonance imaging (MRI) scans of the brain: Subjects will have three MRI scanning sessions to show brain structure and changes in blood flow in different regions of the brain that are responsible for emotion. MRI uses a strong magnetic field and radio waves to produce images of body tissues. During the scan, the subject lies on a table in a narrow cylinder containing a magnetic field and may wear earplugs to muffle loud sounds that occur during the scanning process. While in the scanner, the subject is shown pictures of faces, houses, or words and performs tasks that involve making decisions about the pictures Subjects are also shown pleasant, unpleasant, and neutral pictures; and they are asked to play two games of chance - one that evaluates social cooperation; the other evaluating decision-making. Heart rate, blood pressure and respiration are measured during the scans.
  • Neuropsychological testing: These tests are designed to evaluate memory, learning, attention and concentration, and naming.
  • Aversive conditioning: This procedure examines how the body reacts to unpleasant stimuli, such as a mildly unpleasant electrical stimulation to the wrist or a loud sound, over time. During the test, heart rate, electrodermal activity (sweat), respiration, finger pulse volume, and eyeblink responses will be measured. A small blood sample will be drawn every 5 minutes to evaluate plasma levels of various stress hormones, including cortisol, neuropeptide Y, norepinephrine, and others.
  • Genetic and biological testing: Patients who agree to genetic testing will have a blood sample drawn for DNA studies to better understand the biology and pharmacology of PTSD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2003

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 17, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2003

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2012

Completed
Last Updated

December 9, 2019

Status Verified

September 17, 2012

First QC Date

September 17, 2003

Last Update Submit

December 6, 2019

Conditions

Keywords

Post-Traumatic Stress DisorderNeural CircuitsFearEmotional RegulationRewardPTSD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age.
  • Able to give written informed consent prior to participation in this study.
  • Non-Combat Veterans: Not currently on medications for PTSD or other medications that would interfere with cognitive function. Patients will not be discontinued from effective medication for purposes of the study.
  • Combat Veterans: Some OIF/OEF veterans may not be medication free at the time of scanning. However, they will meet criteria for PTSD according to DSM IV and meet a severity score of greater than or equal to 50 on the CAPS.
  • Resilient subjects or trauma controls will be defined as those subjects who met criteria for significant trauma according to "A" criteria for PTSD (DSM-IV) but did not develop PTSD symptoms.

You may not qualify if:

  • Have a clinically significant or unstable medical disorder.
  • Meet DSM-IV criteria for alcohol and/or substance abuse or substance dependence within 6 months prior to screening.
  • Currently on fluoxetine (justification: washout from fluoxetine could take up to six weeks).
  • Currently at high risk for homicide or suicide.
  • A current or past history of other Axis 1 disorders such as schizophrenia, schizoaffective disorder, bipolar disorder. However, those with a comorbid history of other Axis 1 disorders such as major depression, dysthymia, or panic disorder will be included. (Justification: approximately 70% of subjects with PTSD have comorbid depression and or alcohol abuse (Breslau 2001). Restricting the sample to PTSD patients without depression would not accurately reflect the biology of this disorder).
  • For WRMAC study: Have donated a Red Cross unit of blood within 60 days prior to study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Adolphs R, Tranel D, Hamann S, Young AW, Calder AJ, Phelps EA, Anderson A, Lee GP, Damasio AR. Recognition of facial emotion in nine individuals with bilateral amygdala damage. Neuropsychologia. 1999 Sep;37(10):1111-7. doi: 10.1016/s0028-3932(99)00039-1.

    PMID: 10509833BACKGROUND
  • Affleck G, Tennen H. Construing benefits from adversity: adaptational significance and dispositional underpinnings. J Pers. 1996 Dec;64(4):899-922. doi: 10.1111/j.1467-6494.1996.tb00948.x.

    PMID: 8956517BACKGROUND
  • Affleck G, Tennen H, Croog S, Levine S. Causal attribution, perceived benefits, and morbidity after a heart attack: an 8-year study. J Consult Clin Psychol. 1987 Feb;55(1):29-35. doi: 10.1037//0022-006x.55.1.29. No abstract available.

    PMID: 3571655BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticEmotional Regulation

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • James J Blair, Ph.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 17, 2003

First Posted

September 18, 2003

Study Start

September 16, 2003

Study Completion

September 17, 2012

Last Updated

December 9, 2019

Record last verified: 2012-09-17

Locations