Status:
COMPLETED
Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Stress Disorders, Post Traumatic
Trust
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Traumatic experiences can have a profound negative effect on the lives and well-being of both the people who experience them and their loved ones. For those who experience post-traumatic stress disord...
Detailed Description
Substantial recent data highlight the role of social functioning as a primary moderator of therapeutic response in individuals with post-traumatic stress disorder (PTSD) such that interpersonal diffic...
Eligibility Criteria
Inclusion
- Meet criteria for PTSD on the Clinician Administered PTSD Scale (CAPS)
- Priority will be given to Veterans aged 18-50 who have had an onset of symptoms in the past 10 years and are Veterans of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)
- Have been referred for placement in CPT treatment by a clinician in the Trauma Recovery Program at the Michael E DeBakey VA Medical Center (MEDVAMC) or an eligible Veteran who contacts study staff.
- Are able to see the computer display clearly with or without magnetic Resonance imaging (MRI)-compatible corrective lenses
- Are free from current non-psychiatric medical problems impacting cognitive functioning.
- Are cleared to participate by a treating MEDVAMC clinician
- Are able to participate in functional MRI (fMRI)
Exclusion
- Meet Diagnostic and Statistical Manual-IV (DSM-IV)criteria for drug or alcohol abuse in the past 30 days
- History of moderate to severe traumatic brain injury based on any of the following:
- (i) Glasgow Coma Score \< 13
- (ii)alteration of consciousness \> 24 hours; loss of consciousness,30 minutes
- Presence of contraindications to MRI, including but not limited to:
- claustrophobia
- pacemaker
- metal in eyes
- other implants
- Current neurological or general medical conditions known to impact cognitive and/or emotional functioning, including but limited to:
- epilepsy
- Parkinson's disease
- Huntington's disease
- Alzheimer's disease
- stroke
- chemotherapy for cancer
- Acute psychological instability as assessed by a Michael E DeBakey VA Medical Center (MEDVAMC) clinician or study staff
- Concurrent diagnosis of:
- schizophrenia
- schizoaffective disorder
- delusional disorder
- organic psychosis
- and subjects taking antipsychotic medication
Key Trial Info
Start Date :
May 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01244477
Start Date
May 16 2011
End Date
June 30 2018
Last Update
June 27 2019
Active Locations (1)
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1
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030