An interventional study of Trauma Management Therapy and Exposure Therapy with Psychotherapy group in PTSD, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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.
Other: Trauma Management Therapy
Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.
Other: Exposure Therapy with Psychotherapy group
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.
Also known as: TMT
Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.
Also known as: EXP+GRP
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).
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).
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).
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).
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).
| Milestone | Trauma Management Therapy | Exposure Therapy With Psychoeducation |
|---|---|---|
| Started | 40 | 29 |
| Completed | 29 | 24 |
| Not completed | 11 | 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. \[edited 2/24/24: Higher scores mean a worse outcome.\]
| score on a scale | Trauma Management Therapy | Exposure Therapy With Psychoeducation |
|---|---|---|
| Pre-treatment | 38.39 ± 2.834358 | 35.67 ± 1.76075 |
| Post-treatment | 27.15 ± 4.324715 | 29.31 ± 2.813394 |
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). \[edited 2/24/24 Higher scores mean a worse outcome.\]
| mean score on a scale | Trauma Management Therapy | Exposure Therapy With Psychoeducation |
|---|---|---|
| Pre-treatment | 2.855 ± 0.1321421 | 3.168 ± 0.1061295 |
| Post-treatment | 2.953 ± 0.1869682 | 3.289 ± 0.125691 |
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.
| score on a scale | Trauma Management Therapy | Exposure Therapy With Psychoeducation |
|---|---|---|
| Pre-treatment | 53.66 ± 2.594175 | 56.92 ± 2.917909 |
| Post-treatment | 40.04 ± 3.610813 | 46.53 ± 4.15784 |
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.
| score on a scale | Trauma Management Therapy | Exposure Therapy With Psychoeducation |
|---|---|---|
| Pre-treatment | 59 ± 1.83896 | 64.62 ± 1.715036 |
| Post-treatment | 58.92 ± 2.066746 | 62.18 ± 3.193785 |
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. \[edited 2/24/24: Higher scores mean a better outcome.\]
| score on a scale | Trauma Management Therapy | Exposure Therapy With Psychoeducation |
|---|---|---|
| Pre-treatment | 60.21 ± 2.266907 | 57.54 ± 1.917671 |
| Post-treatment | 63.33 ± 2.491774 | 60.41 ± 4.027533 |
Collected over 7 months, 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trauma Management Therapy | 2/40 (5%) | 1/40 (2.5%) | 0/40 (0%) |
| Exposure Therapy With Psychoeducation | 0/29 (0%) | 1/29 (3.4%) | 0/29 (0%) |
| Event | Trauma Management Therapy | Exposure Therapy With Psychoeducation |
|---|---|---|
| Syncopal episodeCardiac disorders | 0/40 | 1/29 |
| Psychiatric hospitalizationPsychiatric disorders | 1/40 | 0/29 |
Treatment seeking Veterans with Post-Traumatic Stress Disorder (PTSD) assigned to each treatment group
| Age, Continuous(years) | Trauma Management Therapy | Exposure Therapy With Psychoeducation | Total |
|---|---|---|---|
| Mean | 51.65 ± 9.40 | 43.83 ± 10.35 | 48.36 ± 10.49 |
| Sex: Female, Male(Participants) | Trauma Management Therapy | Exposure Therapy With Psychoeducation | Total |
|---|---|---|---|
| Female | 12 | 8 | 20 |
| Male | 28 | 21 | 49 |
| Ethnicity (NIH/OMB)(Participants) | Trauma Management Therapy | Exposure Therapy With Psychoeducation | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 38 | 26 | 64 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Trauma Management Therapy | Exposure Therapy With Psychoeducation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 17 | 8 | 25 |
| White | 19 | 19 | 38 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 1 | 1 | 2 |
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Stress Disorders, Post-Traumatic→
VA Office of Research and Development