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Home > "P" Clinical Trials Conditions > Psychobiological Mechanisms of Resilience to Trauma  Psychobiological Mechanisms of Resilience to Trauma
Psychobiological Mechanisms of Resilience to Trauma
For Condition: Stress Disorders, Post-Traumatic
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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 groups of resilient and non-resilient veterans who have had similar kinds of traumatic experiences: prisoners of war, veterans who have been recognized for acts of combat bravery, and active duty special operations forces. Comparison groups will include veterans exposed but resilient to combat trauma (special operations forces will also be compared to veterans not exposed to combat). 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA: Over 18 years of age. Male (justification: The majority of prisoners of war, combat medal winners, and active duty special operations forces are male). 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. Adult women who have experienced physical and/or sexual abuse or other non-combat related trauma. 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). Have donated a Red Cross unit of blood within 60 days prior to study participation.
Total Enrollment: 135
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030292; 03-M-0292
Study Start Date: September 16, 2003
Record last reviewed: September 4, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069212
Other Stress Disorders, Post-Traumatic Studies:
1. Treatment of Post Traumatic Stress Disorder in Patients with other Mental Illnesses
2. Optimal Treatment Strategies for Sexually Abused Children
3. Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Individuals with Severe Mental Illness
4. Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault
5. Psychobiological Mechanisms of Resilience to Trauma
Related Studies:
Other Stress Disorders, Post-Traumatic Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Psychobiological Mechanisms of Resilience to Trauma
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