Stress Disorders, Post-TraumaticNCT00069212
Psychobiological Mechanisms of Resilience to Trauma
An observational study of Stress Disorders, Post-Traumatic, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2003to 17 Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Post-Traumatic Stress Disorder, Neural Circuits, Fear, Emotional Regulation, Reward, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic, Emotional Regulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2003 (estimated)
- Study start16 Sep 2003
- Study completion17 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- James J Blair, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069212
- Sponsor's protocol ID
- 030292
- Other IDs
- 03-M-0292
- Status last verified
- 17 Sep 2012
- First submitted
- 17 Sep 2003
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Adolphs R, Tranel D, Hamann S, Young AW, Calder AJ, Phelps EA, Anderson A, Lee GP, Damasio AR. Recognition of facial emotion in nine individuals with bilateral amygdala damage. Neuropsychologia. 1999 Sep;37(10):1111-7. doi: 10.1016/s0028-3932(99)00039-1.
PubMed 10509833Affleck G, Tennen H. Construing benefits from adversity: adaptational significance and dispositional underpinnings. J Pers. 1996 Dec;64(4):899-922. doi: 10.1111/j.1467-6494.1996.tb00948.x.
PubMed 8956517Affleck G, Tennen H, Croog S, Levine S. Causal attribution, perceived benefits, and morbidity after a heart attack: an 8-year study. J Consult Clin Psychol. 1987 Feb;55(1):29-35. doi: 10.1037//0022-006x.55.1.29. No abstract available.
PubMed 3571655
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychobiological Mechanisms of Resilience to Trauma
- ClinicalTrials.gov ID
- NCT00069212
- Acronym / sponsor ID
- 030292
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Post-Traumatic Stress Disorder, Neural Circuits, Fear, Emotional Regulation, Reward, PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 16 Sep 2003
- Study completion
- 17 Sep 2012
- First posted
- 18 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 10509833Adolphs R, Tranel D, Hamann S, Young AW, Calder AJ, Phelps EA, Anderson A, Lee GP, Damasio AR. Recognition of facial emotion in nine individuals with bilateral amygdala damage. Neuropsychologia. 1999 Sep;37(10):1111-7. doi: 10.1016/s0028-3932(99)00039-1.
- Background: PubMed 8956517Affleck G, Tennen H. Construing benefits from adversity: adaptational significance and dispositional underpinnings. J Pers. 1996 Dec;64(4):899-922. doi: 10.1111/j.1467-6494.1996.tb00948.x.
- Background: PubMed 3571655Affleck G, Tennen H, Croog S, Levine S. Causal attribution, perceived benefits, and morbidity after a heart attack: an 8-year study. J Consult Clin Psychol. 1987 Feb;55(1):29-35. doi: 10.1037//0022-006x.55.1.29. No abstract available.
Related trials for Stress Disorders, Post-Traumatic
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J Blair, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00069212, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.