NCT03581981: PE-PC

Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD)

Completed NA Results posted Last updated 15 July 2024

What this trial tests

NA trial testing Prolonged Exposure for Primary Care (PE-PC) in Posttraumatic Stress Disorder in 120 participants. Completed in 12 September 2022.

Timeline

1 April 2019

Primary endpoint
12 September 2022

12 September 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	1 April 2019
Primary completion	12 September 2022
Estimated completion	12 September 2022
Sites	2 locations across United States

Drugs / interventions tested

• Prolonged Exposure for Primary Care (PE-PC)
• Treatment as Usual

Conditions studied

• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

World Health Organization Disability Assessment Scale 2.0 Change Primary · Week 6 to Week 0

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	-7.5	± 21.3
Treatment as Usual (TAU)	-4.3	± 14.9

World Health Organization Disability Assessment Scale 2.0 Primary · Week 12

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	56.9	± 28.8
Treatment as Usual (TAU)	51.5	± 24.1

World Health Organization Disability Assessment Scale 2.0 Primary · Week 24

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	58.1	± 29.7
Treatment as Usual (TAU)	53.9	± 28.3

Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change Secondary · Week 6 to Week 0

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	-3.4	± 11.1
Treatment as Usual (TAU)	-3.1	± 7.4

PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change Secondary · Week 6 to Week 0

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	-6.9	± 18.1
Treatment as Usual (TAU)	-5.7	± 7.7

Patient Health Questionnaire- 9 (PHQ-9) Change Secondary · Week 6 to week 0

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	-1.1	± 5.9
Treatment as Usual (TAU)	-2.0	± 4.4

Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Secondary · Week 12

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	28.8	± 14.0
Treatment as Usual (TAU)	28.4	± 11.2

Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Secondary · Week 24

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	28.1	± 12.7
Treatment as Usual (TAU)	28.6	± 11.8

PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Secondary · Week 12

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	41.1	± 20.4
Treatment as Usual (TAU)	40.2	± 15.6

PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Secondary · Week 24

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.

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	42.1	± 20.5
Treatment as Usual (TAU)	40.5	± 16.6

Patient Health Questionnaire- 9 (PHQ-9) Secondary · Week 12

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+

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	12.5	± 6.8
Treatment as Usual (TAU)	12.8	± 5.9

Patient Health Questionnaire- 9 (PHQ-9) Secondary · Week 24

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+

Group	Value	95% CI
Prolonged Exposure for Primary Care (PE-PC)	13.1	± 6.6
Treatment as Usual (TAU)	12.2	± 5.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prolonged Exposure for Primary Care (PE-PC)

Serious: 1/59 (2%)

Deaths: 0/59

Treatment as Usual (TAU)

Serious: 0/61 (0%)

Deaths: 0/61

Serious adverse events (1 terms)

Reaction	System	Prolonged Exposure for Pri…	Treatment as Usual (TAU)
Attempted Suicide	Psychiatric disorders	—	—

Most-reported serious reactions: Attempted Suicide.

Data from ClinicalTrials.gov NCT03581981 adverse events section.

Sponsor's own description

The proposed project will examine a promising brief therapy for posttraumatic stress Disorder (PTSD) for use in Veterans Health Administration (VHA) Primary Care and its impact on functional outcomes. This intervention will provide an alternative point of access to effective PTSD treatment and improved function that does not require referral to specialty mental health and accomplishes improved function in a short-term, brief protocol. Many Veterans prefer to receive mental health care, including PTSD service in primary care. The current protocol would allow them to access effective therapy options in addition to the medication management that is currently the standard of care for PTSD in primary care. In addition, this brief protocol may reduce the number of specialty mental health referrals as many Veterans may not require additional PTSD specific treatment after completion. Thus, if effective, this protocol will greatly increase Veteran treatment choice and improve functional outcomes and access while also increasing efficiency of allocation of specialty PTSD services.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Improving function through primary care treatment of posttraumatic stress disorder study outcomes: A randomized controlled trial of prolonged exposure for primary care in veterans.
   Rauch SAM, Kim HM, Acierno R, Ragin C, et al · · 2023 · cited 7× · PMID 37650808 · DOI 10.1037/fsh0000823
2. The Impact of COVID-19 on Psychotherapy Participation Among Individuals With Posttraumatic Stress Disorder Enrolled in Treatment Research.
   McLean CP, Back SE, Capone C, Morland L, et al · · 2022 · cited 5× · PMID 34291832 · DOI 10.1002/jts.22718
3. Improving function through primary care treatment of PTSD: The IMPACT study protocol.
   Rauch SAM, Kim HM, Acierno R, Ragin C, et al · · 2022 · cited 2× · PMID 35964868 · DOI 10.1016/j.cct.2022.106881
4. Trajectories of change in prolonged exposure for primary care: Who most likely benefits?
   Rauch SAM, Kim HM, Acierno R, Ragin C, et al · · 2025 · PMID 39847013 · DOI 10.1037/tra0001827