Psychobiological Mechanisms of Resilience to Trauma



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:September 16, 2003
End Date:September 17, 2012

Use our guide to learn which trials are right for you!

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.

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 women 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.

- INCLUSION CRITERIA:

- 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.

- All subjects must be in good physical health as confirmed through the screening
session (under screening protocol 01-M-0254). 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.

EXCLUSION CRITERIA:

- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
Click here to add this to my saved trials