Trial Outcomes & Findings for Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach (NCT NCT02400710)
NCT ID: NCT02400710
Last Updated: 2016-02-03
Results Overview
Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
8 weeks
Results posted on
2016-02-03
Participant Flow
Participant milestones
| Measure |
Clinician-Supported PTSD Coach
Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.
Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
|
Self-Managed PTSD Coach
One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinician-Supported PTSD Coach vs. Self-Managed PTSD Coach
Baseline characteristics by cohort
| Measure |
Clinician-Supported PTSD Coach
n=10 Participants
Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.
Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
|
Self-Managed PTSD Coach
n=10 Participants
One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
PTSD Checklist-Specific
|
51.0 units on a scale
STANDARD_DEVIATION 7.7 • n=5 Participants
|
56.0 units on a scale
STANDARD_DEVIATION 15.3 • n=7 Participants
|
53.5 units on a scale
STANDARD_DEVIATION 12.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksMeasures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85.
Outcome measures
| Measure |
Clinician-Supported PTSD Coach
n=10 Participants
Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.
Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
|
Self-Managed PTSD Coach
n=10 Participants
One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app.
|
|---|---|---|
|
PTSD Checklist-Specific
|
40.0 units on a scale
Standard Deviation 10.9
|
49.8 units on a scale
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: 16 weeksAttendance of at least one session in the PTSD specialty clinic following the completion of the study intervention.
Outcome measures
| Measure |
Clinician-Supported PTSD Coach
n=10 Participants
Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.
Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
|
Self-Managed PTSD Coach
n=10 Participants
One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.
Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app.
|
|---|---|---|
|
Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record
|
7 participants
|
1 participants
|
Adverse Events
Clinician-Supported PTSD Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-Managed PTSD Coach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kyle Possemato, Ph.D.
Center for Integrated Healthcare, Syracuse Veterans Affairs Medical Center
Phone: 315-425-4400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place