Trial Outcomes & Findings for An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach (NCT NCT02685358)
NCT ID: NCT02685358
Last Updated: 2024-03-04
Results Overview
The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
234 participants
Primary outcome timeframe
Baseline
Results posted on
2024-03-04
Participant Flow
Participant milestones
| Measure |
Clinician-Supported PTSD Coach
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
119
|
|
Overall Study
COMPLETED
|
100
|
112
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach
Baseline characteristics by cohort
| Measure |
Clinician-Supported PTSD Coach
n=115 Participants
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=119 Participants
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.04 years
STANDARD_DEVIATION 15.40 • n=5 Participants
|
51.75 years
STANDARD_DEVIATION 15.47 • n=7 Participants
|
50.92 years
STANDARD_DEVIATION 15.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
86 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian/Pacific American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Missing
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
115 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
|
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
|
28.52 units on a scale
STANDARD_DEVIATION 10.40 • n=5 Participants
|
30.01 units on a scale
STANDARD_DEVIATION 10.36 • n=7 Participants
|
29.28 units on a scale
STANDARD_DEVIATION 10.38 • n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThe CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.
Outcome measures
| Measure |
Clinician-Supported PTSD Coach
n=115 Participants
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=119 Participants
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
|
28.52 score on a scale
Standard Error 0.97
|
30.01 score on a scale
Standard Error 0.95
|
PRIMARY outcome
Timeframe: 16 and 24 weeksPopulation: For this outcome, only participants continuing to report significant PTSD symptoms (i.e., at or above the PCL-5 clinical cut score of 33) at 8 weeks were included. Per the protocol, these participants were offered a referral to specialty mental health treatment for PTSD.
Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic during the follow-up period.
Outcome measures
| Measure |
Clinician-Supported PTSD Coach
n=59 Participants
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=83 Participants
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
Hospital Administrative Data Showing 2 Mental Health Visits Completed
|
21 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline, 8 week, 16 week, 24 weekThe PCL-5 is a 20-item self-report measure assessing how much respondents have been bothered by DSM-5 PTSD symptoms in the past month. Scores can range from 0 to 80 with higher scores reflecting worse PTSD symptom severity.
Outcome measures
| Measure |
Clinician-Supported PTSD Coach
n=115 Participants
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=119 Participants
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
PTSD Checklist-5 (PCL-5)
Baseline
|
46.30 score on a scale
Standard Error 1.05
|
47.18 score on a scale
Standard Error 1.03
|
|
PTSD Checklist-5 (PCL-5)
8-week
|
36.34 score on a scale
Standard Error 1.2
|
40.68 score on a scale
Standard Error 1.15
|
|
PTSD Checklist-5 (PCL-5)
16-week
|
35.42 score on a scale
Standard Error 1.43
|
38.99 score on a scale
Standard Error 1.35
|
|
PTSD Checklist-5 (PCL-5)
24-week
|
34.61 score on a scale
Standard Error 1.69
|
38.05 score on a scale
Standard Error 1.58
|
SECONDARY outcome
Timeframe: 8 weekThe CSQ is a widely used 8-item self-report measure assessing patient satisfaction with care. Scores can range from 8 to 32 with higher scores reflecting greater satisfaction.
Outcome measures
| Measure |
Clinician-Supported PTSD Coach
n=115 Participants
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=119 Participants
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
Client Satisfaction Questionnaire (CSQ)
|
27.10 score on a scale
Standard Deviation 3.73
|
24.60 score on a scale
Standard Deviation 4.82
|
SECONDARY outcome
Timeframe: Baseline, 8 week, 16 week, 24 weekA 9-item self-report instrument used to assess depression severity. Items are scored 0 to 3, with the total score being the sum of the 9 items which can range from 0 as the minimum value to 27 as the maximum value. Higher scores indicate greater depression severity, with a score of 10 or greater indicating probable major depression, and scores of 20 or more severe major depression.
Outcome measures
| Measure |
Clinician-Supported PTSD Coach
n=115 Participants
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=119 Participants
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Baseline
|
12.51 score on a scale
Standard Error .48
|
13.63 score on a scale
Standard Error .47
|
|
Patient Health Questionnaire (PHQ-9)
24-week
|
10.22 score on a scale
Standard Error .61
|
11.30 score on a scale
Standard Error .57
|
|
Patient Health Questionnaire (PHQ-9)
8-week
|
11.03 score on a scale
Standard Error .50
|
12.12 score on a scale
Standard Error .48
|
|
Patient Health Questionnaire (PHQ-9)
16-week
|
10.79 score on a scale
Standard Error .55
|
11.80 score on a scale
Standard Error .52
|
SECONDARY outcome
Timeframe: Baseline, 8 week, 16 week, 24 weekThe psychological health (6 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-30 with higher scores reflecting better quality of life.
Outcome measures
| Measure |
Clinician-Supported PTSD Coach
n=115 Participants
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=119 Participants
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
WHOQOL-BREF Psychological Health Subscale
Baseline Psych Subscale
|
17.82 score on a scale
Standard Error .35
|
17.51 score on a scale
Standard Error .34
|
|
WHOQOL-BREF Psychological Health Subscale
8-week Psych Subscale
|
18.16 score on a scale
Standard Error .37
|
17.50 score on a scale
Standard Error .35
|
|
WHOQOL-BREF Psychological Health Subscale
16-week Psych Subscale
|
18.04 score on a scale
Standard Error .39
|
17.65 score on a scale
Standard Error .37
|
|
WHOQOL-BREF Psychological Health Subscale
24-week Psych Subscale
|
18.29 score on a scale
Standard Error .42
|
17.47 score on a scale
Standard Error .40
|
SECONDARY outcome
Timeframe: Baseline, 8 week, 16 week, 24 weekThe social relationships (3 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-15 with higher scores reflecting better quality of life.
Outcome measures
| Measure |
Clinician-Supported PTSD Coach
n=115 Participants
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=119 Participants
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
WHOQOL-BREF Social Relationships Subscale
Baseline Social Subscale
|
8.88 score on a scale
Standard Error .24
|
8.56 score on a scale
Standard Error .23
|
|
WHOQOL-BREF Social Relationships Subscale
8-week Social Subscale
|
9.31 score on a scale
Standard Error .24
|
8.71 score on a scale
Standard Error .23
|
|
WHOQOL-BREF Social Relationships Subscale
16-week Social Subscale
|
9.23 score on a scale
Standard Error .26
|
8.58 score on a scale
Standard Error .24
|
|
WHOQOL-BREF Social Relationships Subscale
24-week Social Subscale
|
9.01 score on a scale
Standard Error .27
|
8.40 score on a scale
Standard Error .25
|
Adverse Events
Clinician-Supported PTSD Coach
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Primary Care Mental Health Integrated Care as Usual
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clinician-Supported PTSD Coach
n=115 participants at risk
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=119 participants at risk
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
Blood and lymphatic system disorders
Emergency Department Visit
|
0.00%
0/115 • For each enrolled participant, adverse event data was collected for the duration of their study participation, which was 24 weeks.
|
0.84%
1/119 • Number of events 1 • For each enrolled participant, adverse event data was collected for the duration of their study participation, which was 24 weeks.
|
Other adverse events
| Measure |
Clinician-Supported PTSD Coach
n=115 participants at risk
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
|
Primary Care Mental Health Integrated Care as Usual
n=119 participants at risk
Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition
|
|---|---|---|
|
Psychiatric disorders
Acute anger
|
0.87%
1/115 • Number of events 1 • For each enrolled participant, adverse event data was collected for the duration of their study participation, which was 24 weeks.
|
0.00%
0/119 • For each enrolled participant, adverse event data was collected for the duration of their study participation, which was 24 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place