Clinical trial NCT01244477: Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)
Official title: Neuroimaging the Impact of Treatment on Neural Substrates of Trust in PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post Traumatic
Trust
Keywords: Stress Disorders, Post Traumatic
Trust
functional Magnetic Resonance Imaging (fMRI)
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-11-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

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, the investigators 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, the investigators seek to examine changes in neurobehavioral substrates of social functioning following treatment for Veterans with PTSD. Specifically, the investigators 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.

Thus, the broad goals of this project are two-fold. First, the investigators 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, the investigators seek to examine changes in neurobehavioral substrates of social functioning following treatment for veterans with PTSD. Specifically, the investigators 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 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 \< 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

Primary outcomes:
measure: Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan
timeFrame: Pre & post a 12 week treatment group
measure: The Clinician Administered PTSD Scale (CAPS)
timeFrame: Pre & post a 12 week treatment group
Secondary outcomes:
measure: Behavioral Expression of Trust on the Trust Game
timeFrame: Pre & post a 12 week treatment group
measure: PTSD Checklist (PCL)
timeFrame: Administered each week at weekly group sessions or pre-post treatment as usual
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Wright Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References: