Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)
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Purpose
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, we 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.
| Condition | Intervention |
|---|---|
|
Stress Disorders, Post Traumatic Trust |
Behavioral: Group CPT-C |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Neuroimaging the Impact of Treatment on Neural Substrates of Trust in PTSD |
- Continuous whole brain imaging with standard imaging parameters for each fMRI scan [ Time Frame: Pre & post a 12 week treatment group ] [ Designated as safety issue: No ]
- Behavioral Expression of trust on the trust game [ Time Frame: Pre & post a 12 week treatment group ] [ Designated as safety issue: No ]
- The Clinician Administered PTSD Scale (CAPS) [ Time Frame: Pre & post a 12 week treatment group ] [ Designated as safety issue: No ]
- PTSD Checklist (PCL) [ Time Frame: Administered each week at weekly group sessions ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Participants in group CPT-C
|
Behavioral: Group CPT-C
Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks.
|
|
No Intervention: Arm 2
Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
|
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 difficulties and mistrust significantly and negatively impact treatment efficacy (Forbes et al., 2003; Forbes et al., 2005; Forbes et al., 2008). In addition, ample evidence suggests that psychotherapy improves the social and interpersonal lives of psychotherapy clients through improving clients' abilities to regulate their emotions and reduce social isolation (Yalom & Leszcz, 2005; Foy et al., 2000). While considerable research has been dedicated to exploring the neurobiology of emotional dysregulation associated with PTSD (Rauch, Shin, & Phelps, 2006; Etkin & Wager, 2007), and increasing data suggest that diverse psychotherapies affect neural functioning (Beauregard 2007), very little is understood about the neurobehavioral pathology underlying the debilitating interpersonal difficulties in PTSD, or the neurobiological mechanisms accompanying the improvements in social functioning that occur with efficacious therapy.
Thus, the broad goals of this project are two-fold. First, we seek to examine the neural substrates associated with interpersonal dysfunction in PTSD using a social exchange game previously developed to assess interpersonal trust and cooperation in healthy (King-Casas et al., 2005) and psychiatric groups (Chiu et al., 2008; King-Casas et al., 2008). Second, we seek to examine changes in neurobehavioral substrates of social functioning following treatment for veterans with PTSD. Specifically, we propose to use functional magnetic resonance imaging (fMRI) and behavior within a well-characterized Trust Game to examine the neural substrates associated with interpersonal trust and cooperation in veterans with PTSD prior to and following empirically supported psychotherapy cognitive processing therapy (CPT) for PTSD.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meet criteria for PTSD on the 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 MR-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 fMRI
Exclusion Criteria:
- Meet 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
Contacts and Locations| United States, Texas | |
| Michael E. DeBakey VA Medical Center (152) | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Wright Williams, PhD | Michael E. DeBakey VA Medical Center (152) |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01244477 History of Changes |
| Other Study ID Numbers: | B7760-P |
| Study First Received: | November 17, 2010 |
| Last Updated: | March 26, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Stress Disorders, Post Traumatic Trust functional Magnetic Resonance Imaging (fMRI) |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013