An interventional study of Group CPT-C in Stress Disorders, Post Traumatic and Trust, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-06-27.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Basic science
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.
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.
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This study's enrollment of 61 is below the median of 72 across 119 interventional studies indexed under Combat Disorders.
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Exclusion Criteria:
History of moderate to severe traumatic brain injury based on any of the following:
Presence of contraindications to MRI, including but not limited to:
Current neurological or general medical conditions known to impact cognitive and/or emotional functioning, including but limited to:
Concurrent diagnosis of:
Participants in group CPT-C
Behavioral: Group CPT-C
Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
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.
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
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.
Time frame: Pre & post a 12 week treatment group
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.
Time frame: Pre & post a 12 week treatment group
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.
Time frame: Administered each week at weekly group sessions or pre-post treatment as usual
| Milestone | CPT-C | Treatment-as-Usual |
|---|---|---|
| Started | 38 | 23 |
| Completed | 18 | 20 |
| Not completed | 20 | 3 |
No measurements were reported for this outcome.
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.
| CAPS Scores | CPT-C | Treatment-as-Usual |
|---|---|---|
| Pre-Therapy or before 12 weeks | 79.3 ± 18.6 | 66.3 ± 26.2 |
| Post-Therapy or after 12 weeks | 70.3 ± 24.1 | 69.5 ± 22.8 |
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.
| Ratio | CPT-C | Treatment-as-Usual |
|---|---|---|
| Pre-Treatment Investment Ratio | .31 ± .17 | .34 ± .23 |
| Post-Treatment Investment Ratio | .37 ± .27 | .28 ± .25 |
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.
| PCL Scores | CPT-C | Treatment-as-Usual |
|---|---|---|
| Pre-Treatment PCL-M Scores | 65.33 ± 11.0 | 56.83 ± 17.1 |
| Post-Treatment PCL-M Scores | 58.37 ± 13.48 | 59.53 ± 11.88 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CPT-C | — | 0/38 (0%) | 0/38 (0%) |
| Treatment-as-Usual | — | 0/23 (0%) | 0/23 (0%) |
| Age, Categorical(Participants) | CPT-C | Treatment-as-Usual | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 38 | 23 | 61 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | CPT-C | Treatment-as-Usual | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 31 | 19 | 50 |
| Race/Ethnicity, Customized(participants) | CPT-C | Treatment-as-Usual | Total |
|---|---|---|---|
| Black/African American | 13 | 5 | 18 |
| Hispanic or Latino | 6 | 5 | 11 |
| Mixed Race | 4 | 1 | 5 |
| Caucasian or White | 15 | 12 | 27 |
Plan to share: No
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