Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)
Primary Purpose
Stress Disorders, Post Traumatic, Trust
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group CPT-C
Sponsored by
About this trial
This is an interventional basic science trial for Stress Disorders, Post Traumatic focused on measuring Stress Disorders, Post Traumatic, Trust, functional Magnetic Resonance Imaging (fMRI)
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
Sites / Locations
- Michael E. DeBakey VA Medical Center, Houston, TX
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CPT-C
Treatment-as-Usual
Arm Description
Participants in group CPT-C
Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
Outcomes
Primary Outcome Measures
Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan
The Clinician Administered PTSD Scale (CAPS)
The CAPS is considered the gold standard measure of PTSD symptoms. CAPS scores are the sum of 17 questions. Each is question is scored from 0 (best possible outcome) to 8 (worst possible outcome). The lowest possible CAPS score is a 0, indicating no PTSD symptoms reported. The highest possible CAPS score is a 136, indicating the most PTSD symptoms reported.
Secondary Outcome Measures
Behavioral Expression of Trust on the Trust Game
The Investment Ratio (IR) is the amount subjects were willing to invest in a social partner. It is considered a measure of interpersonal trust, and co-operation. It is a ratio ranging from 0 (indicating no willingness to trust a social partner) to 1.0 (willing to totally trust a social partner). It consists of the percentage of total points the subject was willing to invest in a social partner divided by the total points they received for all ten rounds of the trust game. Higher ratio's indicate more trust.
PTSD Checklist (PCL)
An instrument measuring a participants self-reported level of PTSD symptoms. PCL scores are the sum of 17 questions. Each is question is scored from 1 (best possible outcome) to 5 (worst possible outcome). The lowest possible PCL score is a 17, indicating no troublesome PTSD symptoms reported. The highest possible PCL score is a 85, indicating the worst degree of PTSD symptoms reported.
Full Information
NCT ID
NCT01244477
First Posted
November 17, 2010
Last Updated
June 21, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01244477
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 16, 2011 (Actual)
Primary Completion Date
May 31, 2013 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post Traumatic, Trust
Keywords
Stress Disorders, Post Traumatic, Trust, functional Magnetic Resonance Imaging (fMRI)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPT-C
Arm Type
Experimental
Arm Description
Participants in group CPT-C
Arm Title
Treatment-as-Usual
Arm Type
No Intervention
Arm Description
Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
Intervention Type
Behavioral
Intervention Name(s)
Group CPT-C
Intervention Description
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.
Primary Outcome Measure Information:
Title
Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan
Time Frame
Pre & post a 12 week treatment group
Title
The Clinician Administered PTSD Scale (CAPS)
Description
The CAPS is considered the gold standard measure of PTSD symptoms. CAPS scores are the sum of 17 questions. Each is question is scored from 0 (best possible outcome) to 8 (worst possible outcome). The lowest possible CAPS score is a 0, indicating no PTSD symptoms reported. The highest possible CAPS score is a 136, indicating the most PTSD symptoms reported.
Time Frame
Pre & post a 12 week treatment group
Secondary Outcome Measure Information:
Title
Behavioral Expression of Trust on the Trust Game
Description
The Investment Ratio (IR) is the amount subjects were willing to invest in a social partner. It is considered a measure of interpersonal trust, and co-operation. It is a ratio ranging from 0 (indicating no willingness to trust a social partner) to 1.0 (willing to totally trust a social partner). It consists of the percentage of total points the subject was willing to invest in a social partner divided by the total points they received for all ten rounds of the trust game. Higher ratio's indicate more trust.
Time Frame
Pre & post a 12 week treatment group
Title
PTSD Checklist (PCL)
Description
An instrument measuring a participants self-reported level of PTSD symptoms. PCL scores are the sum of 17 questions. Each is question is scored from 1 (best possible outcome) to 5 (worst possible outcome). The lowest possible PCL score is a 17, indicating no troublesome PTSD symptoms reported. The highest possible PCL score is a 85, indicating the worst degree of PTSD symptoms reported.
Time Frame
Administered each week at weekly group sessions or pre-post treatment as usual
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wright Williams, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)
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