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Neuroimaging the Impact of Treatment on Neural Substrates of Trust in Post-Traumatic Stress Disorder (PTSD)

Neuroimaging the Impact of Treatment on Neural Substrates of Trust in PTSD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01244477
Enrollment
61
Registered
2010-11-19
Start date
2011-05-16
Completion date
2018-06-30
Last updated
2019-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post Traumatic, Trust

Keywords

Stress Disorders, Post Traumatic, Trust, functional Magnetic Resonance Imaging (fMRI)

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.

Interventions

BEHAVIORALGroup 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) ScanPre & post a 12 week treatment group
The Clinician Administered PTSD Scale (CAPS)Pre & post a 12 week treatment groupThe 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

MeasureTime frameDescription
Behavioral Expression of Trust on the Trust GamePre & post a 12 week treatment groupThe 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)Administered each week at weekly group sessions or pre-post treatment as usualAn 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
CPT-C
Participants in group CPT-C 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.
38
Treatment-as-Usual
Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
23
Total61

Baseline characteristics

CharacteristicCPT-CTreatment-as-UsualTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
38 Participants23 Participants61 Participants
Race/Ethnicity, Customized
Black/African American
13 participants5 participants18 participants
Race/Ethnicity, Customized
Caucasian or White
15 participants12 participants27 participants
Race/Ethnicity, Customized
Hispanic or Latino
6 participants5 participants11 participants
Race/Ethnicity, Customized
Mixed Race
4 participants1 participants5 participants
Sex: Female, Male
Female
7 Participants4 Participants11 Participants
Sex: Female, Male
Male
31 Participants19 Participants50 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 380 / 23
serious
Total, serious adverse events
0 / 380 / 23

Outcome results

Primary

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

Population: Neural data is not analyzable - scanner technicians changed the parameters of the task fMRI on an unpredictable basis. Project staff and data no longer available.

Primary

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

Population: We limited this arm to 18 subjects who completed 9+ out of 12 treatment sessions.

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: CPT-C GroupThe Clinician Administered PTSD Scale (CAPS)Pre-Therapy or before 12 weeks79.3 CAPS ScoresStandard Deviation 18.6
Arm 1: CPT-C GroupThe Clinician Administered PTSD Scale (CAPS)Post-Therapy or after 12 weeks70.3 CAPS ScoresStandard Deviation 24.1
Arm 2: Waitlist Control GroupThe Clinician Administered PTSD Scale (CAPS)Pre-Therapy or before 12 weeks66.3 CAPS ScoresStandard Deviation 26.2
Arm 2: Waitlist Control GroupThe Clinician Administered PTSD Scale (CAPS)Post-Therapy or after 12 weeks69.5 CAPS ScoresStandard Deviation 22.8
Secondary

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

Population: Veterans with PTSD under 50 years of age

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: CPT-C GroupBehavioral Expression of Trust on the Trust GamePre-Treatment Investment Ratio.31 RatioStandard Deviation 0.17
Arm 1: CPT-C GroupBehavioral Expression of Trust on the Trust GamePost-Treatment Investment Ratio.37 RatioStandard Deviation 0.27
Arm 2: Waitlist Control GroupBehavioral Expression of Trust on the Trust GamePre-Treatment Investment Ratio.34 RatioStandard Deviation 0.23
Arm 2: Waitlist Control GroupBehavioral Expression of Trust on the Trust GamePost-Treatment Investment Ratio.28 RatioStandard Deviation 0.25
Secondary

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

Population: Veterans under 50 years of age diagnosed with PTSD

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1: CPT-C GroupPTSD Checklist (PCL)Pre-Treatment PCL-M Scores65.33 PCL ScoresStandard Deviation 11
Arm 1: CPT-C GroupPTSD Checklist (PCL)Post-Treatment PCL-M Scores58.37 PCL ScoresStandard Deviation 13.48
Arm 2: Waitlist Control GroupPTSD Checklist (PCL)Pre-Treatment PCL-M Scores56.83 PCL ScoresStandard Deviation 17.1
Arm 2: Waitlist Control GroupPTSD Checklist (PCL)Post-Treatment PCL-M Scores59.53 PCL ScoresStandard Deviation 11.88

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026