Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069212
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2003-09-17
Brief Title:
Psychobiological Mechanisms of Resilience to Trauma
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Psychobiological Mechanisms of Resilience to Trauma
Status:
COMPLETED
Status Verified Date:
2012-09-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-M-0292 | None | None | None |