N/A
N=120
Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD)
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03581981 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Jul 2024
Primary outcome: Primary: World Health Organization Disability Assessment Scale 2.0 Change — -7.5; -4.3 units on a scale — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prolonged Exposure for Primary Care (PE-PC) (Behavioral); Treatment as Usual (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY World Health Organization Disability Assessment Scale 2.0 Change |
-7.5; -4.3 | 0.33 |
| PRIMARY World Health Organization Disability Assessment Scale 2.0 |
58.1; 53.9 | 0.89 |
| PRIMARY World Health Organization Disability Assessment Scale 2.0 |
58.1; 53.9 | 0.89 |
| SECONDARY Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) Change |
-3.4; -3.1 | 0.99 |
| SECONDARY PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) Change |
-6.9; -5.7 | 0.52 |
| SECONDARY Patient Health Questionnaire- 9 (PHQ-9) Change |
-1.1; -2.0 | 0.50 |
| SECONDARY Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) |
28.1; 28.6 | 0.99 |
| SECONDARY Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5) |
28.1; 28.6 | 0.99 |
| SECONDARY PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) |
42.1; 40.5 | 0.69 |
| SECONDARY PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) |
42.1; 40.5 | 0.69 |
| SECONDARY Patient Health Questionnaire- 9 (PHQ-9) |
13.1; 12.2 | 0.41 |
| SECONDARY Patient Health Questionnaire- 9 (PHQ-9) |
13.1; 12.2 | 0.41 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Any era Veterans seeking care in VA PC for PTSD symptoms [PTSD Checklist for Diagnostic and Statistical Manual 5 (PCL-5) of at least 28)] and PTSD confirmed based on Clinician Administered PTSD Scale for Diagnostic and Statistical Manual 5 (CAPS-5)
- English speaking
- Report significant impairment in function related to PTSD symptoms as noted on intake World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
- Report that they want treatment for PTSD
- If individuals are taking psychotropic medication, 2-weeks on stable dose will be required prior to enrollment
Exclusion Criteria
- Other primary clinical issue that would interfere with PTSD treatment
- Level of suicidal risk as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) that requires:
- PTSD + interested and consent to study
- Primary Care Provider (PCP) Screen:
- Primary Care- Posttraumatic Stress Disorder Screen (PC-PTSD) + Intake
- PCMHI Provider:
- [PCL 28] + brief interview
- No PTSD OR
- Not interested in treatment OR
- Not interested in study
- Severe cognitive impairment that, in the judgment of the investigator, makes it unlikely that the patient can adhere to the study regimen
- Psychosis or unmanaged bipolar disorder
- Moderate to severe substance use disorder in the past 8 weeks
- Patients who are currently receiving talk therapy for trauma-related symptoms
Data sourced from ClinicalTrials.gov (NCT03581981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.