N/A
Completed N=916
Comparative Effectiveness Research in Veterans With PTSD
Source: ClinicalTrials.gov NCT01928732 ↗Enrolled (actual)
916
Serious AEs
12.9%
Results posted
Jan 2022
Primary outcomePrimary: Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS) — 24.3; 27.2; 26.4; 28.7 score on a scale
Summary
VA Cooperative Study CSP #591 is designed to compare the effectiveness of two types of psychotherapy, Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT), for treating posttraumatic stress disorder (PTSD) in male and female Veterans. Despite solid evidence that both treatments are effective in Veterans and non-Veterans, there is a lack of evidence about the effectiveness of these treatments compared with one another.
The sample will include 900 male and female Veterans with PTSD due to any traumatic military event. Veterans who are eligible and agree to participate in the study will be randomly assigned (by chance) to receive Prolonged Exposure or Cognitive Processing Therapy. The standard "dose" of treatment is 12 weekly sessions but Veterans who improve more rapidly may finish in fewer sessions and Veterans who improve more slowly may have additional sessions. The primary outcome is improvement in PTSD symptoms after treatment. The outcome will be measured at regular follow-up visits that will occur at the middle and at the end of treatment and then 3 and 6 months later. The investigators will measure other outcomes, including additional mental health problems, functioning, quality of life, and use of treatments for mental and physical problems. The investigators also will measure Veterans' treatment preference and examine whether Veterans who get the treatment they prefer do better than Veterans who get the less-preferred treatment.
As a large multi-site trial with men and women, CSP #591 is designed to provide conclusive information about whether one treatment is better than the other, overall and for different types of patients-for example, men vs. women, combat Veterans vs. Veterans who experienced military sexual trauma, and older vs. younger Veterans. Regardless of the outcome, patients will have more information to help them make an informed decisions about which treatment to choose and VA will have stronger evidence to help make care Veteran-centered.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS) |
24.3; 27.2; 26.4; 28.7; 24.8; 26.9 | — |
| SECONDARY Posttraumatic Diagnostic Scale (PDS-5) |
33.5; 36.7; 34.5; 37.5; 33.6; 36.7 | — |
| SECONDARY Beck Depression Inventory-II (BDI-II) |
22.0; 22.7; 22.2; 23.6; 21.9; 22.9 | — |
| SECONDARY Spielberger State Anger Inventory (STAXI) |
93.4; 94.6; 93.2; 94.7; 93.2; 94.5 | — |
| SECONDARY Short Inventory of Problems - Revised (SIP-R) |
2.61; 2.49; 2.42; 2.29; 3.09; 1.72 | — |
| SECONDARY Brief Addiction Monitor (BAM) |
0.88; 0.86; 1.0; 0.94; 0.96; 0.80 | — |
| SECONDARY World Health Organization Disability Assessment Schedule (WHO-DAS-II) |
28.6; 28.6; 28.0; 28.7; 28.5; 28.5 | — |
| SECONDARY World Health Organization Quality of Life (WHOQoL-BREF) |
47.0; 48.6; 47.0; 47.0; 47.1; 46.9 | — |
Eligibility Criteria
Inclusion Criteria
Current PTSD and symptom severity of 25 or higher on the Clinician- Administered PTSD Scale (Weathers et al., 2013); agreement to not receive psychotherapy for PTSD during study treatment and allow digital recording of phone interviews and therapy; regular access to a telephone (or agreement to come to the VA for centrally conducted telephone interviews for participant who do not have telephone access). Medication for PTSD and other mental or physical conditions, psychotherapy for other problems, brief visits with an existing therapist, and self-help groups will be allowed.
Exclusion Criteria
- substance dependence not in remission for at least 1 month;
- current psychotic symptoms and mania (including manic phase of bipolar disorder);
- significant current suicidal or homicidal ideation that includes a specific plan;
- or moderate to severe cognitive impairment defined as 1 SD below age-graded norms on the Montreal Cognitive Assessment.
Data sourced from ClinicalTrials.gov (NCT01928732). 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.