N/A
Completed N=134
PTSD (PostTraumatic Stress Disorder) Services for Veterans With SMI (Severe Mental Illness)
Source: ClinicalTrials.gov NCT01542229 ↗Enrolled (actual)
134
Serious AEs
0.8%
Results posted
Jul 2019
Primary outcomePrimary: Posttraumatic Stress Disorder (PTSD) Checklist (PCL) — 66.94; 66.33; 51.20; 60.60 score on a scale
Summary
As in the general population, there is no clear standard of care within Veterans Affairs Medical Centers for treating posttraumatic stress disorder (PTSD) among individuals with severe mental illness (SMI). This is a considerable issue because trauma, posttraumatic stress disorder (PTSD), and severe psychiatric comorbidity are particularly common among Veterans and this symptom presentation clearly exacerbates the overall course and severity of mental illness. This study is significant in that it proposes to establish the efficacy of a frontline exposure based intervention for posttraumatic stress disorder (PTSD), Prolonged Exposure, for improving critical clinical, quality of life, and cost outcomes among Veterans with severe mental illness (SMI) enrolled in VA healthcare. Collectively, it is anticipated that these data will establish a much needed clinical course of action for what is considered a vulnerable yet highly underserved patient population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Posttraumatic Stress Disorder (PTSD) Checklist (PCL) |
66.94; 66.33; 51.20; 60.60 | — |
| PRIMARY Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) |
69.00; 62.91; 49.42; 68.42 | — |
| SECONDARY Beck Depression Inventory-II (BDI-II) |
37.26; 31.54; 26.52; 30.00 | — |
| SECONDARY Brief Psychiatric Rating Scale-Extended (BPRS-E) |
47.34; 44.87; 33.72; 35.29 | — |
| SECONDARY Veterans SF 12 Health Survey (SF-12) |
36.69; 42.48; 44.31; 42.70 | — |
| SECONDARY Pittsburgh Seep Quality Index |
2.47; 2.45; 2.00; 2.29 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Posttraumatic Stress Disorder (PTSD) on the Clinician Administered PTSD Scale (CAPS; Blake et al., 1990);
- A confirmed diagnosis of a psychotic disorder, bipolar disorder, or severe unipolar depression on the Mini Neuropsychiatric Interview (MINI; Sheehan et al., 1998).
Exclusion Criteria
- Having a household member who is already enrolled in the study;
- Active psychosis, mania, or dementia at screening;
- Suicidal ideation with clear intent;
- Current substance dependence; and
- Concurrent enrollment in another clinical trial for PTSD or depression.
Data sourced from ClinicalTrials.gov (NCT01542229). 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. Informational only — not medical advice.