Trial Outcomes & Findings for Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD) (NCT NCT03581981)
NCT ID: NCT03581981
Last Updated: 2024-07-15
Results Overview
Change in total score between Week 6 and Week 0 time points can range from 144 (total disability after full function) to 0 (no change) to -144 (total recovery of all function after total disability). Lower change scores reflect more return of function between timepoints. Cut points for this measure have not yet been established.
COMPLETED
NA
120 participants
Week 6 to Week 0
2024-07-15
Participant Flow
recruited in VA Primary Care from April 2019 to September 2021
Excluded (n = 129) * Not meeting inclusion criteria or did not consent to study (n = 84) * Declined to participate (n = 45)
Participant milestones
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
Brief version of Prolonged Exposure (PE) provided in 30 minute sessions in Primary Care (PC)
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
Veterans assigned to Primary Care (PC) Mental Health Integration (PCMHI)- Treatment as Usual (TAU) will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
61
|
|
Overall Study
COMPLETED
|
46
|
42
|
|
Overall Study
NOT COMPLETED
|
13
|
19
|
Reasons for withdrawal
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
Brief version of Prolonged Exposure (PE) provided in 30 minute sessions in Primary Care (PC)
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
Veterans assigned to Primary Care (PC) Mental Health Integration (PCMHI)- Treatment as Usual (TAU) will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
13
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD)
Baseline characteristics by cohort
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=59 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=61 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty Mental Health (MH)), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
World Health Organization Disability Assessment Scale 2.0 (WHODAS 2.0)
|
48.8 units on a scale
STANDARD_DEVIATION 18.1 • n=5 Participants
|
46.7 units on a scale
STANDARD_DEVIATION 16.1 • n=7 Participants
|
47.7 units on a scale
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
|
34.0 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
34.1 units on a scale
STANDARD_DEVIATION 9.3 • n=7 Participants
|
34.0 units on a scale
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Patient Health Questionnaire 9 (PHQ-9)
|
14.1 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
15.0 units on a scale
STANDARD_DEVIATION 5.5 • n=7 Participants
|
14.6 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
PTSD Checklist for Diagnostic and Statistical Manual 5(PCL-5)
|
49.4 units on a scale
STANDARD_DEVIATION 11.6 • n=5 Participants
|
50.9 units on a scale
STANDARD_DEVIATION 13.0 • n=7 Participants
|
50.1 units on a scale
STANDARD_DEVIATION 12.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6 to Week 0Population: All those with 4 or fewer missing items on the measure are included in the analysis
Change in total score between Week 6 and Week 0 time points can range from 144 (total disability after full function) to 0 (no change) to -144 (total recovery of all function after total disability). Lower change scores reflect more return of function between timepoints. Cut points for this measure have not yet been established.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=43 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=50 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
World Health Organization Disability Assessment Scale 2.0 Change
|
-7.5 units on a scale
Standard Deviation 21.3
|
-4.3 units on a scale
Standard Deviation 14.9
|
PRIMARY outcome
Timeframe: Week 12Population: All those with 4 or fewer missing items on the measure are included in the analysis
WHODAS is a 36-item disability interviewer administered assessment covering six domains of function: cognition, mobility, self-care, getting along, life activities, and participation. Each item is scored as none, mild, moderate, severe, or extreme/cannot do. Simple scoring where items are summed across the scale was used. Total scores can range from range from 0 (no disability) to 144 (full disability) with higher scores indicate greater functional impairment.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=48 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=42 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
World Health Organization Disability Assessment Scale 2.0
|
56.9 units on a scale
Standard Deviation 28.8
|
51.5 units on a scale
Standard Deviation 24.1
|
PRIMARY outcome
Timeframe: Week 24Population: All those with 4 or fewer missing items on the measure are included in the analysis
WHODAS is a 36-item disability interviewer administered assessment covering six domains of function: cognition, mobility, self-care, getting along, life activities, and participation. Each item is scored as none, mild, moderate, severe, or extreme/cannot do. Simple scoring where items are summed across the scale was used. Total scores can range from range from 0 (no disability) to 144 (full disability) with higher scores indicate greater functional impairment.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=46 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=42 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
World Health Organization Disability Assessment Scale 2.0
|
58.1 units on a scale
Standard Deviation 29.7
|
53.9 units on a scale
Standard Deviation 28.3
|
SECONDARY outcome
Timeframe: Week 6 to Week 0Population: All those with 4 or fewer missing items on the measure are included in the analysis
Change scores range between Week 6 and Week 0 time points from 80 (Most severe PTSD after no PTSD) to 0 (no change) to -80 (No PTSD after most severe PTSD). Lower change score indicates more reduction in PTSD. Cut points for this change measure have not yet been established.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=43 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=50 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change
|
-3.4 units on a scale
Standard Deviation 11.1
|
-3.1 units on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Week 6 to Week 0Population: All those with 4 or fewer missing items on the measure are included in the analysis
Change scores range between Week 6 and Week 0 time points from 80 (Most severe PTSD after no PTSD) to 0 (no change) to -80 (No PTSD after most severe PTSD). Lower change score indicates more reduction in PTSD. Cut points for this change measure have not yet been established.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=41 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=48 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change
|
-6.9 units on a scale
Standard Deviation 18.1
|
-5.7 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Week 6 to week 0Population: All those with 4 or fewer missing items on the measure are included in the analysis
Change scores range between Week 6 and Week 0 time points from 27 (Most severe depression after no depression) to 0 (no change) to -27 (No depression after most severe depression). Lower change score indicates more reduction in depression. Cut points for this change measure have not yet been established.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=41 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=47 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
Patient Health Questionnaire- 9 (PHQ-9) Change
|
-1.1 units on a scale
Standard Deviation 5.9
|
-2.0 units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Week 12Population: All those with 4 or fewer missing items on the measure are included in the analysis
CAPS-5 is a 30 -item interviewer administered assessment of PTSD severity over the past month. Each item is scored as absent, mild/subthreshold, moderate/threshold, severe/markedly elevated, or extreme/incapacitating and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. Clinical cut scores for interpretation of this measure have not yet been established.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=48 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=42 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
|
28.8 units on a scale
Standard Deviation 14.0
|
28.4 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Week 24Population: All those with 4 or fewer missing items on the measure are included in the analysis
CAPS-5 is a 30 -item interviewer administered assessment of PTSD severity over the past month. Each item is scored as absent, mild/subthreshold, moderate/threshold, severe/markedly elevated, or extreme/incapacitating and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. Clinical cut scores for interpretation of this measure have not yet been established.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=46 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=42 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
|
28.1 units on a scale
Standard Deviation 12.7
|
28.6 units on a scale
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Week 12Population: All those with 4 or fewer missing items on the measure are included in the analysis
PCL-5 is a 20 item self-report assessment of the PTSD symptoms over the past month. Each item is scored as not at all, a little bit, moderately, quite a bit, or extremely and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. PCL-5 cutoff score between 31-33 is indicative of probable PTSD.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=47 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=38 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
|
41.1 units on a scale
Standard Deviation 20.4
|
40.2 units on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Week 24Population: All those with 4 or fewer missing items on the measure are included in the analysis
PCL-5 is a 20 item self-report assessment of the PTSD symptoms over the past month. Each item is scored as not at all, a little bit, moderately, quite a bit, or extremely and summed for the total score. The scores ranges from 0 to 80 higher as more severe PTSD. PCL-5 cutoff score between 31-33 is indicative of probable PTSD.
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=44 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=39 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5)
|
42.1 units on a scale
Standard Deviation 20.5
|
40.5 units on a scale
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Week 12Population: All those with 4 or fewer missing items on the measure are included in the analysis
PHQ-9 is a 9 item self-report measure of depressive symptoms over the past two weeks. Each item is scored as not at all, several days, more than half days, or nearly every day and summed for the total score. Scores range from 0 (no depression) to 27 (most severe depression). Higher scores would be more severe depression and 10 and higher is considered depressed. Total scores are interpreted as: Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=47 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=38 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
Patient Health Questionnaire- 9 (PHQ-9)
|
12.5 units on a scale
Standard Deviation 6.8
|
12.8 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Week 24Population: All those with 4 or fewer missing items on the measure are included in the analysis
PHQ-9 is a 9 item self-report measure of depressive symptoms over the past two weeks. Each item is scored as not at all, several days, more than half days, or nearly every day and summed for the total score. Scores range from 0 (no depression) to 27 (most severe depression). Higher scores would be more severe depression and 10 and higher is considered depressed. Total scores are interpreted as: Minimal 1-4; Mild 5-9; moderate 10-14; Moderately sever 15-19; Severe 20+
Outcome measures
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=44 Participants
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=39 Participants
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
Patient Health Questionnaire- 9 (PHQ-9)
|
13.1 units on a scale
Standard Deviation 6.6
|
12.2 units on a scale
Standard Deviation 5.9
|
Adverse Events
Prolonged Exposure for Primary Care (PE-PC)
Treatment as Usual (TAU)
Serious adverse events
| Measure |
Prolonged Exposure for Primary Care (PE-PC)
n=59 participants at risk
Brief version of PE provided in 30 minute sessions in PC
Prolonged Exposure for Primary Care (PE-PC): Brief version of PE provided in 30 minute sessions in PC
|
Treatment as Usual (TAU)
n=61 participants at risk
Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
Treatment as Usual: Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
|
|---|---|---|
|
Psychiatric disorders
Attempted Suicide
|
1.7%
1/59 • Number of events 1 • 24 weeks
Adverse events were collected at each clinical or assessment contact.
|
0.00%
0/61 • 24 weeks
Adverse events were collected at each clinical or assessment contact.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place