N/A
N=61
Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)
Stress Disorders, Post Traumatic · Trust
Bottom Line
View on ClinicalTrials.gov: NCT01244477 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group CPT-C (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan |
— | — |
| PRIMARY The Clinician Administered PTSD Scale (CAPS) |
79.3; 66.3; 70.3; 69.5 | — |
| SECONDARY Behavioral Expression of Trust on the Trust Game |
.31; .34; .37; .28 | — |
| SECONDARY PTSD Checklist (PCL) |
65.33; 56.83; 58.37; 59.53 | — |
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 disorder (PTSD), their interpersonal difficulties and social support further impact the success of treatment such that interpersonal difficulties are associated with mistrust and predict poor treatment outcome. In this proposal, the investigators use functional neuroimaging to understand the neurobiology of trust and mistrust in people with PTSD and to learn more about how successful treatment can improve trust and social functioning.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT01244477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.