Stress Disorders, Post-Traumatic Clinical Trial
Official title:
Psychobiological Mechanisms of Resilience to Trauma
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05620381 -
Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
|
||
Completed |
NCT02856412 -
Improving Mind/Body Health and Functioning With Integrative Exercise
|
N/A | |
Recruiting |
NCT05400200 -
PTSD and Self-regulation: Coping, Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management
|
N/A | |
Not yet recruiting |
NCT06088303 -
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
|
N/A | |
Not yet recruiting |
NCT03652922 -
Propranolol Reactivation Mismatch (PRM) Treatment for PTSD
|
Phase 4 | |
Completed |
NCT02875912 -
Prospective Evaluation of Family Care Rituals in the ICU
|
N/A | |
Completed |
NCT01589575 -
Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
|
N/A | |
Completed |
NCT00990106 -
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT01291368 -
Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care
|
N/A | |
Active, not recruiting |
NCT00657787 -
Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
|
||
Completed |
NCT00835627 -
Treatment Trial for Psychogenic Nonepileptic Seizures
|
Phase 4 | |
Completed |
NCT01365247 -
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT00880152 -
Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
|
N/A | |
Completed |
NCT00514956 -
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)
|
Phase 1 | |
Completed |
NCT00419029 -
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
|
N/A | |
Completed |
NCT00333710 -
Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
|
N/A | |
Completed |
NCT01120847 -
Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
|
||
Completed |
NCT00069225 -
Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder
|
N/A | |
Completed |
NCT00055354 -
Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT00186212 -
Alternative Support for Rural and Isolated Women in an HMO
|
Phase 3 |