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Psychobiological Mechanisms of Resilience to Trauma
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), July 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00069212

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.

Stress Disorders, Post-Traumatic

MedlinePlus related topics: Injuries Nuclear Scans Post-Traumatic Stress Disorder Wounds
U.S. FDA Resources
Study Type: Observational
Official Title: Psychobiological Mechanisms of Resilience to Trauma

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 300
Study Start Date: September 2003
Detailed Description:

Since the majority of research studies in posttraumatic stress disorder (PTSD) have focused on the pathological consequences of exposure to trauma, there is a paucity of information on the psychobiology of subjects who are resilient to severe stress. The proposed study will comprehensively evaluate the neural circuits that mediate fear, reward, social cooperation, memory, and emotional regulation in traumatized men and women with and without PTSD and healthy subjects. Subject groups will include prisoners of war, active duty special operations forces, returning Iraqi veterans (approval pending), and men and women exposed to non-combat traumas including sexual and or physical abuse. Comparison groups will include men and momen exposed to trauma without PTSD (resilient subjects), and healthy men and women who have never been exposed to trauma. Changes in neural circuitry associated with resilience will be evaluated using functional magnetic resonance imaging (fMRI). Relationships and interactions among the neural circuits mediating fear, reward, social cooperation, memory, and emotional regulation will be assessed and correlated with clinical, neuroendocrine, and neuropsychological findings. Identification of biological and psychosocial correlates of resilience could help predict illness vulnerability following exposure to trauma and could assist in the selection of "hardy" subjects for high-risk professions.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Over 18 years of age.

Able to give written informed consent prior to participation in this study.

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).

Nonresponders to other psychotropic drugs must have discontinued them for at least 2 weeks prior to the first fMRI scan. Medications will be discontinued under the supervision of the subject's treating psychiatrist or primary care physician. (Nonresponders will be defined as subjects who continue to meet criteria for PTSD despite treatment with 30 mg equivalent or greater of paroxetine for a minimum duration of six weeks).

In good physical health as confirmed by a complete physical exam (including normal vital signs), electrocardiogram, neurological exam, and routine laboratory tests of blood and urine. However, if subjects participated in other research studies or had blood work through their primary MD within the prior 6 months, these results will be used instead of repeating blood draws for inclusion into the study. Subjects with stable medical problems will be included.

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.


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).

Have donated a Red Cross unit of blood within 60 days prior to study participation.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069212

Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

United States, District of Columbia
Howard University Hospital Recruiting
Washington, District of Columbia, United States, 20060
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20301
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Study ID Numbers: 030292, 03-M-0292
Study First Received: September 17, 2003
Last Updated: August 14, 2008
ClinicalTrials.gov Identifier: NCT00069212  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Post-Traumatic Stress Disorder
Neural Circuits
Emotional Regulation
Post-Traumatic Stress Disorder

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Wounds and Injuries
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on January 30, 2009