PTSD
Conditions
Keywords
PTSD, neuroimaging, fMRI, veterans, exposure therapy, treatment
Brief summary
Social difficulties are serious and frequent complicating factors in the treatment of post-traumatic stress disorder (PTSD). To better understand how treatment of post-traumatic stress disorder impacts neural mechanisms of social cognition, the investigators are examining behavior and brain processes associated with response to Trauma Management Therapy. Understanding the behavioral and neural impact of psychotherapy may contribute to development of more effective treatments for PTSD.
Detailed description
PTSD is associated with significant interpersonal difficulties that interfere with functioning. As such, this work is intended to evaluate the empirical support for a novel treatment that fills a significant gap in the treatment options available to Veterans with PTSD who suffer with interpersonal difficulties. In this study the investigators will (i) evaluate the efficacy of Trauma Management Therapy (TMT) for treating PTSD-related interpersonal dysfunction, as well as PTSD-related fear and anxiety, and (ii) evaluate neural mediators of clinical improvements associated with TMT. This work will provide insights into the mechanisms by which treatments may lead to improvements in social functioning, informing both the biological basis of psychotherapy and the development and refinement of alternative therapeutic interventions targeting social impairments. Treatment seeking Veterans with PTSD will be randomized to one of two treatments: (i) Trauma Management Therapy, consisting of 12 sessions of individualized exposure therapy followed by 24 sessions of group-based social and emotional rehabilitation, or (ii) Exposure + Comparison Treatment Group consisting of 12 sessions of individualized exposure therapy followed by 24 sessions of group-based psychotherapy. Veterans enrolled in both the TMT and EXP+GRP arms will undergo functional neuroimaging as they engage in an emotional image viewing task, as well as two social interaction tasks. Neurobehavioral assessments will be made prior to and following completion of treatment.
Interventions
Trauma Management Therapy (TMT) consists of a combination of 12 sessions of individualized exposure therapy and 24 sessions of group-based social and emotion rehabilitation.
OTHERExposure Therapy with Psychotherapy group
Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female veterans of all ethnicities * Meet diagnostic criteria for post-traumatic stress disorder (assessed by study staff) * Fluent in English * Able to see computer display clearly * Able to provide informed consent * Able to follow written or verbal instructions
Exclusion criteria
* history of seizures * history of stroke * Cushing's syndrome * history of moderate to severe traumatic brain injury * electroconvulsive therapy within 5 years * history of chemotherapy for cancer * contraindications to fMRI * pregnancy * diagnosis of schizophrenia, schizoaffective disorder, delusional disorder and/or organic psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician-Administered PTSD Scale for DSM-5 | CAPS-5 will be assessed at two time-points per participant: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8). | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al. 2013; 2017) is a 20 item semi-structured instrument for the diagnosis and assessment of severity of posttraumatic stress disorder (PTSD). Each DSM-5 item is rated on a 0 (absent) to 4 (extreme/incapacitating) scale, and total score is calculated by summing severity scores across items. Total CAPS-5 severity can range from 0 to 80. \[edited 2/24/24: Higher scores mean a worse outcome.\] |
| Change in Social Adjustment Scale - Self-Report | SAS will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8). | The Social Adjustment Scale (SAS; Weissman & Bothwell, 1976) is a 54 item self-report measure that assesses social adjustment in six social areas of functioning including work, social and leisure activities, extended family, marital, parental, and family. Each item is rated on a five point scale, and within each of domain items are averaged. Thus, scores in each domain can range between 1 (high social adjustment) and 5 (low social adjustment). \[edited 2/24/24 Higher scores mean a worse outcome.\] |
| Change in PTSD Checklist for DSM-5 | The PCL-5 will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8). | The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013; Bovin et al., 2016) is a 20 item self-report measure assessing DSM-5 PTSD symptom severity. Each DSM-5 item is rated on a 0 (absent) to 4 (extreme/incapacitating) scale, and total score is calculated by summing severity scores across items. Total CAPS-5 severity can range from 0 to 80. Higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Aggression Questionnaire | AQ will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8). | Change in Aggression Questionnaire (AQ; Buss & Warren, 2000) is a 34 item self-report measure that assesses severity of self-perceived aggression and anger. Each item is rated on a 1 (Not at all like me) to 5 (Completely like me) scale, and scores of all items are summed. Scores can range from 34 to 170. Higher scores mean a worse outcome. |
| Change in Interpersonal Trust Scale | ITS will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8). | Change in Interpersonal Trust Scale (ITS; Rotter, 1967) is a 25 item self-report measure that assesses trust within relationships. Each item is rated on a 1 (low trust) to 5 (high trust) scale, and total scores can range from 25 to 125. \[edited 2/24/24: Higher scores mean a better outcome.\] |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trauma Management Therapy Trauma Management Therapy (TMT) consists of a combination of 12 sessions of individualized exposure therapy and 24 sessions of group-based social and emotion rehabilitation.
Trauma Management Therapy: Trauma Management Therapy (TMT) consists of a combination of 12 sessions of individualized exposure therapy and 24 sessions of group-based social and emotion rehabilitation. | 40 |
| Exposure Therapy With Psychoeducation Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.
Exposure Therapy with Psychotherapy group: Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation. | 29 |
| Total | 69 |
Baseline characteristics
| Characteristic | Exposure Therapy With Psychoeducation | Total | Trauma Management Therapy |
|---|---|---|---|
| Age, Continuous | 43.83 years STANDARD_DEVIATION 10.35 | 48.36 years STANDARD_DEVIATION 10.49 | 51.65 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 64 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 25 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 38 Participants | 19 Participants |
| Sex: Female, Male Female | 8 Participants | 20 Participants | 12 Participants |
| Sex: Female, Male Male | 21 Participants | 49 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 40 | 0 / 29 |
| other Total, other adverse events | 0 / 40 | 0 / 29 |
| serious Total, serious adverse events | 1 / 40 | 1 / 29 |
Outcome results
Primary
Change in Clinician-Administered PTSD Scale for DSM-5
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al. 2013; 2017) is a 20 item semi-structured instrument for the diagnosis and assessment of severity of posttraumatic stress disorder (PTSD). Each DSM-5 item is rated on a 0 (absent) to 4 (extreme/incapacitating) scale, and total score is calculated by summing severity scores across items. Total CAPS-5 severity can range from 0 to 80. \[edited 2/24/24: Higher scores mean a worse outcome.\]
Time frame: CAPS-5 will be assessed at two time-points per participant: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).
Population: Data analysis at pre-treatment was limited to participants who had completed this measure. At post-treatment, analysis was limited to participants who had begun treatment and had completed this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trauma Management Therapy | Change in Clinician-Administered PTSD Scale for DSM-5 | Post-treatment | 27.15 score on a scale | Standard Error 4.324715 |
| Trauma Management Therapy | Change in Clinician-Administered PTSD Scale for DSM-5 | Pre-treatment | 38.39 score on a scale | Standard Error 2.834358 |
| Exposure Therapy With Psychoeducation | Change in Clinician-Administered PTSD Scale for DSM-5 | Post-treatment | 29.31 score on a scale | Standard Error 2.813394 |
| Exposure Therapy With Psychoeducation | Change in Clinician-Administered PTSD Scale for DSM-5 | Pre-treatment | 35.67 score on a scale | Standard Error 1.76075 |
Comparison: Test of prediction of dependent variable -- the CAPS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, agep-value: 0.4154Regression, Linear
Primary
Change in PTSD Checklist for DSM-5
The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013; Bovin et al., 2016) is a 20 item self-report measure assessing DSM-5 PTSD symptom severity. Each DSM-5 item is rated on a 0 (absent) to 4 (extreme/incapacitating) scale, and total score is calculated by summing severity scores across items. Total CAPS-5 severity can range from 0 to 80. Higher scores mean a worse outcome.
Time frame: The PCL-5 will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).
Population: Data analysis at pre-treatment was limited to participants who had completed this measure. At post-treatment, analysis was limited to participants who had begun treatment and had completed this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trauma Management Therapy | Change in PTSD Checklist for DSM-5 | Pre-treatment | 53.66 score on a scale | Standard Error 2.594175 |
| Trauma Management Therapy | Change in PTSD Checklist for DSM-5 | Post-treatment | 40.04 score on a scale | Standard Error 3.610813 |
| Exposure Therapy With Psychoeducation | Change in PTSD Checklist for DSM-5 | Pre-treatment | 56.92 score on a scale | Standard Error 2.917909 |
| Exposure Therapy With Psychoeducation | Change in PTSD Checklist for DSM-5 | Post-treatment | 46.53 score on a scale | Standard Error 4.15784 |
Comparison: Test of prediction of dependent variable -- the PCL score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, agep-value: 0.735129Regression, Linear
Primary
Change in Social Adjustment Scale - Self-Report
The Social Adjustment Scale (SAS; Weissman & Bothwell, 1976) is a 54 item self-report measure that assesses social adjustment in six social areas of functioning including work, social and leisure activities, extended family, marital, parental, and family. Each item is rated on a five point scale, and within each of domain items are averaged. Thus, scores in each domain can range between 1 (high social adjustment) and 5 (low social adjustment). \[edited 2/24/24 Higher scores mean a worse outcome.\]
Time frame: SAS will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).
Population: Data analysis at pre-treatment was limited to participants who had completed this measure. At post-treatment, analysis was limited to participants who had begun treatment and had completed this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trauma Management Therapy | Change in Social Adjustment Scale - Self-Report | Pre-treatment | 2.855 mean score on a scale | Standard Error 0.1321421 |
| Trauma Management Therapy | Change in Social Adjustment Scale - Self-Report | Post-treatment | 2.953 mean score on a scale | Standard Error 0.1869682 |
| Exposure Therapy With Psychoeducation | Change in Social Adjustment Scale - Self-Report | Pre-treatment | 3.168 mean score on a scale | Standard Error 0.1061295 |
| Exposure Therapy With Psychoeducation | Change in Social Adjustment Scale - Self-Report | Post-treatment | 3.289 mean score on a scale | Standard Error 0.125691 |
Comparison: Test of prediction of dependent variable -- the SAS-SR score-- with the interaction between Visit (pre/post) and Treatment type (TMT vs. EXP+EDU), as well as independent variable, agep-value: 0.4636Regression, Linear
Secondary
Change in Aggression Questionnaire
Change in Aggression Questionnaire (AQ; Buss & Warren, 2000) is a 34 item self-report measure that assesses severity of self-perceived aggression and anger. Each item is rated on a 1 (Not at all like me) to 5 (Completely like me) scale, and scores of all items are summed. Scores can range from 34 to 170. Higher scores mean a worse outcome.
Time frame: AQ will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).
Population: Data analysis at pre-treatment was limited to participants who had completed this measure. At post-treatment, analysis was limited to participants who had begun treatment and had completed this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trauma Management Therapy | Change in Aggression Questionnaire | Pre-treatment | 59 score on a scale | Standard Error 1.83896 |
| Trauma Management Therapy | Change in Aggression Questionnaire | Post-treatment | 58.92 score on a scale | Standard Error 2.066746 |
| Exposure Therapy With Psychoeducation | Change in Aggression Questionnaire | Post-treatment | 62.18 score on a scale | Standard Error 3.193785 |
| Exposure Therapy With Psychoeducation | Change in Aggression Questionnaire | Pre-treatment | 64.62 score on a scale | Standard Error 1.715036 |
Comparison: Test of prediction of dependent variable -- the AQ score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, agep-value: 0.58Regression, Linear
Secondary
Change in Interpersonal Trust Scale
Change in Interpersonal Trust Scale (ITS; Rotter, 1967) is a 25 item self-report measure that assesses trust within relationships. Each item is rated on a 1 (low trust) to 5 (high trust) scale, and total scores can range from 25 to 125. \[edited 2/24/24: Higher scores mean a better outcome.\]
Time frame: ITS will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).
Population: Data analysis at pre-treatment was limited to participants who had completed this measure. At post-treatment, analysis was limited to participants who had begun treatment and had completed this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trauma Management Therapy | Change in Interpersonal Trust Scale | Pre-treatment | 60.21 score on a scale | Standard Error 2.266907 |
| Trauma Management Therapy | Change in Interpersonal Trust Scale | Post-treatment | 63.33 score on a scale | Standard Error 2.491774 |
| Exposure Therapy With Psychoeducation | Change in Interpersonal Trust Scale | Pre-treatment | 57.54 score on a scale | Standard Error 1.917671 |
| Exposure Therapy With Psychoeducation | Change in Interpersonal Trust Scale | Post-treatment | 60.41 score on a scale | Standard Error 4.027533 |
Comparison: Test of prediction of dependent variable -- the ITS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, agep-value: 0.808Regression, Linear