Trial Outcomes & Findings for Peer Enhanced Prolonged Exposure (NCT NCT02818114)
NCT ID: NCT02818114
Last Updated: 2019-07-02
Results Overview
Number of PE Sessions attended during 10 weeks of participation in study. 10 is the maximum, 0 is the minimum. Higher numbers of sessions attended are an indication of better engagement in treatment.
COMPLETED
NA
8 participants
10 weeks
2019-07-02
Participant Flow
We recruited from veterans screening for Prolonged Exposure (PE) at a Midwestern VA between 6/2017 and 3/2018. Note that the study was open between 10/2016 and 3/2018, because between 10/2016 and 2/2017 we were enrolling focus groups to refine the intervention to be tested in the clinical trial; the focus groups were not the clinical trial..
31 participants were referred by outpatient therapists. 9 were not interested, and 6 did not meet institutional criteria to start PE. 16 consented to interview screening. 5 did not meet criteria to start PE, 2 were lost to follow-up before starting, and one chose not to start PE.
Participant milestones
| Measure |
Peer Enhanced Exposure Therapy (PEET)
Single Arm Feasibility Trial: Peer Enhanced Prolonged Exposure: Peer support interventions as adjunct to Prolonged Exposure
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Peer Enhanced Prolonged Exposure
Baseline characteristics by cohort
| Measure |
PEET
n=8 Participants
Single Arm Feasibility Trial: Peer Enhanced Prolonged Exposure: Peer support interventions as adjunct to prolonged exposure
|
|---|---|
|
Age, Continuous
|
55.25 years
STANDARD_DEVIATION 14.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
|
Posttraumatic Stress Disorder Checklist-5
|
62.00 units on a scale
STANDARD_DEVIATION 9.70 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksNumber of PE Sessions attended during 10 weeks of participation in study. 10 is the maximum, 0 is the minimum. Higher numbers of sessions attended are an indication of better engagement in treatment.
Outcome measures
| Measure |
Peer Enhanced Prolonged Exposure
n=8 Participants
Standard Prolonged Exposure therapy supplemented by weekly, manualized peer support sessions.
|
|---|---|
|
PE Sessions Attended
|
8.63 number of PE sessions attended
Standard Deviation 2.62
|
PRIMARY outcome
Timeframe: 10 weeksSelf-report measure of PTSD symptoms; score range is 0-80, with higher scores indicating more PTSD symptoms.
Outcome measures
| Measure |
Peer Enhanced Prolonged Exposure
n=8 Participants
Standard Prolonged Exposure therapy supplemented by weekly, manualized peer support sessions.
|
|---|---|
|
Posttraumatic Stress Disorder (PTSD) Checklist-5
|
33.14 score on a scale
Standard Deviation 11.63
|
Adverse Events
PEET
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place