Trial Outcomes & Findings for Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD (NCT NCT03449576)
NCT ID: NCT03449576
Last Updated: 2024-07-24
Results Overview
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. \[edited 2/24/24: Higher scores mean a worse outcome.\]
COMPLETED
NA
69 participants
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).
2024-07-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
29
|
|
Overall Study
COMPLETED
|
29
|
24
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD
Baseline characteristics by cohort
| Measure |
Trauma Management Therapy
n=40 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.
|
Exposure Therapy With Psychoeducation
n=29 Participants
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.
|
Total
n=69 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
51.65 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
43.83 years
STANDARD_DEVIATION 10.35 • n=7 Participants
|
48.36 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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. \[edited 2/24/24: Higher scores mean a worse outcome.\]
Outcome measures
| Measure |
Trauma Management Therapy
n=29 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.
|
Exposure Therapy With Psychoeducation
n=24 Participants
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.
|
|---|---|---|
|
Change in Clinician-Administered PTSD Scale for DSM-5
Pre-treatment
|
38.39 score on a scale
Standard Error 2.834358
|
35.67 score on a scale
Standard Error 1.76075
|
|
Change in Clinician-Administered PTSD Scale for DSM-5
Post-treatment
|
27.15 score on a scale
Standard Error 4.324715
|
29.31 score on a scale
Standard Error 2.813394
|
PRIMARY outcome
Timeframe: 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.
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). \[edited 2/24/24 Higher scores mean a worse outcome.\]
Outcome measures
| Measure |
Trauma Management Therapy
n=29 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.
|
Exposure Therapy With Psychoeducation
n=24 Participants
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.
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|---|---|---|
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Change in Social Adjustment Scale - Self-Report
Pre-treatment
|
2.855 mean score on a scale
Standard Error 0.1321421
|
3.168 mean score on a scale
Standard Error 0.1061295
|
|
Change in Social Adjustment Scale - Self-Report
Post-treatment
|
2.953 mean score on a scale
Standard Error 0.1869682
|
3.289 mean score on a scale
Standard Error 0.125691
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Trauma Management Therapy
n=29 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.
|
Exposure Therapy With Psychoeducation
n=24 Participants
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.
|
|---|---|---|
|
Change in PTSD Checklist for DSM-5
Pre-treatment
|
53.66 score on a scale
Standard Error 2.594175
|
56.92 score on a scale
Standard Error 2.917909
|
|
Change in PTSD Checklist for DSM-5
Post-treatment
|
40.04 score on a scale
Standard Error 3.610813
|
46.53 score on a scale
Standard Error 4.15784
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Trauma Management Therapy
n=29 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.
|
Exposure Therapy With Psychoeducation
n=24 Participants
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.
|
|---|---|---|
|
Change in Aggression Questionnaire
Pre-treatment
|
59 score on a scale
Standard Error 1.83896
|
64.62 score on a scale
Standard Error 1.715036
|
|
Change in Aggression Questionnaire
Post-treatment
|
58.92 score on a scale
Standard Error 2.066746
|
62.18 score on a scale
Standard Error 3.193785
|
SECONDARY outcome
Timeframe: 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.
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. \[edited 2/24/24: Higher scores mean a better outcome.\]
Outcome measures
| Measure |
Trauma Management Therapy
n=29 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.
|
Exposure Therapy With Psychoeducation
n=24 Participants
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.
|
|---|---|---|
|
Change in Interpersonal Trust Scale
Pre-treatment
|
60.21 score on a scale
Standard Error 2.266907
|
57.54 score on a scale
Standard Error 1.917671
|
|
Change in Interpersonal Trust Scale
Post-treatment
|
63.33 score on a scale
Standard Error 2.491774
|
60.41 score on a scale
Standard Error 4.027533
|
Adverse Events
Trauma Management Therapy
Exposure Therapy With Psychoeducation
Serious adverse events
| Measure |
Trauma Management Therapy
n=40 participants at risk
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.
|
Exposure Therapy With Psychoeducation
n=29 participants at risk
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.
|
|---|---|---|
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Cardiac disorders
Syncopal episode
|
0.00%
0/40 • 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.
|
3.4%
1/29 • 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.
|
|
Psychiatric disorders
Psychiatric hospitalization
|
2.5%
1/40 • 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.
|
0.00%
0/29 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Shirley Groer (Scientific Program Manager)
Rehabilitation Research & Development
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place