Trial Outcomes & Findings for Optimizing Treatment Response in VA Specialized Intensive/Inpatient PTSD Programs (NCT NCT03533608)
NCT ID: NCT03533608
Last Updated: 2023-07-25
Results Overview
PTSD symptoms will be measured via the PCL-5 at baseline, 6-week, and 2-months. The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Patients are asked to rate how bothered they are by each item in the past month on a 5-point likert scale ranging from 0-4 (not at all, a little bit, moderately, quite a bit, extremely). Items are summed together and a PCL-5 cut point score of 33 is used for provisional PTSD diagnosis. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).
COMPLETED
NA
39 participants
Baseline, 6-week, and 2-months
2023-07-25
Participant Flow
Participant milestones
| Measure |
Group PE
Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Group PE
Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Optimizing Treatment Response in VA Specialized Intensive/Inpatient PTSD Programs
Baseline characteristics by cohort
| Measure |
Group PE
n=39 Participants
Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
|
|---|---|
|
Age, Continuous
|
40.08 Years
STANDARD_DEVIATION 8.47 • n=39 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6-week, and 2-monthsPopulation: Scores are reported for the 39 enrolled participants, including the 5 who did not complete the treatment but agreed to complete the follow-up assessments.
PTSD symptoms will be measured via the PCL-5 at baseline, 6-week, and 2-months. The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Patients are asked to rate how bothered they are by each item in the past month on a 5-point likert scale ranging from 0-4 (not at all, a little bit, moderately, quite a bit, extremely). Items are summed together and a PCL-5 cut point score of 33 is used for provisional PTSD diagnosis. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).
Outcome measures
| Measure |
Group PE
n=39 Participants
Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
Group PE: Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
|
|---|---|
|
Change in PTSD Symptoms
Change in Baseline to 6-weeks
|
-23.86 score on a scale
Standard Deviation 13.81
|
|
Change in PTSD Symptoms
Change in Baseline to 2-months
|
-19.51 score on a scale
Standard Deviation 13.81
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 2-monthsPopulation: Scores are reported for the 39 enrolled participants, including the 5 who did not complete the treatment but agreed to complete the follow-up assessments.
Depressive symptoms will be measured via the PHQ-9 at baseline, 6-weeks, and 2-months. The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day). Individual items are summed together and Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).
Outcome measures
| Measure |
Group PE
n=39 Participants
Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
Group PE: Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
|
|---|---|
|
Change in Depression Symptoms
Change from baseline to 6-weeks
|
-4.68 score on a scale
Standard Deviation 4.51
|
|
Change in Depression Symptoms
Change from baseline to 2-months
|
-4.04 score on a scale
Standard Deviation 4.51
|
Adverse Events
Group PE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rebecca Sripada
Center for Clinical Managment Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place