N/A
N=234
An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02685358 ↗Enrolled (actual)
234
Serious AEs
0.4%
Results posted
Mar 2024
Primary outcome: Primary: Clinician Administered PTSD Scale for DSM-5 (CAPS-5) — 28.52; 30.01 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clinician-Supported PTSD Coach (Behavioral); Primary Care Mental Health Integrated Care as Usual (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale for DSM-5 (CAPS-5) |
28.52; 30.01 | — |
| PRIMARY Hospital Administrative Data Showing 2 Mental Health Visits Completed |
21; 20 | — |
| SECONDARY PTSD Checklist-5 (PCL-5) |
46.30; 47.18; 36.34; 40.68; 35.42; 38.99 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ) |
27.10; 24.60 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
12.51; 13.63; 11.03; 12.12; 10.79; 11.80 | — |
| SECONDARY WHOQOL-BREF Psychological Health Subscale |
17.82; 17.51; 18.16; 17.50; 18.04; 17.65 | — |
| SECONDARY WHOQOL-BREF Social Relationships Subscale |
8.88; 8.56; 9.31; 8.71; 9.23; 8.58 | — |
Summary
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project seeks to improve health care for Veterans by testing the effectiveness of a primary care-based treatment called clinician-supported PTSD Coach. 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. If this treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.
Eligibility Criteria
Inclusion Criteria
- Veterans enrolled in primary care within the VA Syracuse and Palo Alto healthcare systems reporting 33 on the PTSD Checklist-5 (PCL-5) and a traumatic event on the Criterion A screener
Exclusion Criteria
- Patients will be excluded if they demonstrate symptoms that would not allow them to actively engage in the CS PTSD Coach, i.e.,
- gross cognitive impairment
- Current symptoms of mania or psychosis or who have more pressing concerns that need to be addressed first, i.e.,
- suicide attempt in the last two months or current intent to commit suicide
- Patients with recent suicide attempts or intent are eligible to be enrolled follow the receipt of suicide prevention services
- The investigators will also exclude patients that are already receiving psychotherapy or MH counseling for PTSD outside of PC
- Started or changed the dose of a psychotropic medication for PTSD in the last two months that was prescribed outside of VA PC
- Voice a preference to be directly referred to MH specialty care
Data sourced from ClinicalTrials.gov (NCT02685358). 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.