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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma Management Therapy | Experimental | 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. |
|
| Exposure Therapy with Psychoeducation | Active Comparator | Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma Management Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.] | 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). |
| 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.] | 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). |
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brooks King-Casas, PhD | Salem VA Medical Center, Salem, VA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salem VA Medical Center, Salem, VA | Salem | Virginia | 24153 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treatment seeking Veterans with Post-Traumatic Stress Disorder (PTSD) assigned to each treatment group
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.] | 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. | Posted | Mean | Standard Error | score on a scale | 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). |
|
7 months, 3 weeks
Participants were assessed across a period of seven months and three weeks, including seven weeks of treatment and a six month follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncopal episode | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shirley Groer (Scientific Program Manager) | Rehabilitation Research & Development | 202-553-9899 | shirley.groer@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2022 | Jun 15, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2023 | Jul 5, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 6, 2021 | May 8, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007171 | Implosive Therapy |
| D011615 | Psychotherapy, Group |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Exposure Therapy with Psychotherapy group | Other | Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation. |
|
|
| 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.] | 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). |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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. |
| OG001 | 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. |
|
|
|
| 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.] | 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. | Posted | Mean | Standard Error | mean score on a scale | 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). |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | score on a scale | 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). |
|
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| 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. | 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. | Posted | Mean | Standard Error | score on a scale | 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). |
|
|
|
|
| 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.] | 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. | Posted | Mean | Standard Error | score on a 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). |
|
|
|
|
| 2 |
| 40 |
| 1 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. | 0 | 29 | 1 | 29 | 0 | 29 |
| Psychiatric hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| D012960 | Socioenvironmental Therapy |
| Post-treatment |
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| Post-treatment |
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| Post-treatment |
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| Post-treatment |
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