IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Comparative Effectiveness Research in Veterans With PTSD (CERV-PTSD)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
VA Cooperative Study CSP #591 is designed to compare the effectiveness of two types of psychotherapy, Prolonged Exposure and Cognitive Processing Therapy, 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.
| Condition | Intervention |
|---|---|
| Post-Traumatic Stress Disorder | Behavioral: Cognitive Processing Therapy (CPT) Behavioral: Prolonged Exposure (PE) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | CSP #591 - CERV-PTSD: Comparative Effectiveness Research in Veterans With PTSD |
- Improvement in PTSD symptom severity on the Clinician-Administered PTSD Scale. [ Time Frame: 6 months ]The primary outcome is the change of CAPS total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). We chose to use the average in the six months post-treatment in the definition of primary outcome (versus using a single post-treatment timepoint) because we anticipate that improvement established during the course of treatment will be sustained in the 6 months after treatment for both PE and CPT.
| Estimated Enrollment: | 900 |
| Actual Study Start Date: | October 31, 2014 |
| Estimated Study Completion Date: | December 31, 2018 |
| Estimated Primary Completion Date: | September 30, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CPT
Cognitive Processing Therapy (CPT) - a type of cognitive therapy for treating PTSD.
|
Behavioral: Cognitive Processing Therapy (CPT)
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|
Active Comparator: PE
Prolonged Exposure (PE) - a type of exposure therapy for treating PTSD.
|
Behavioral: Prolonged Exposure (PE)
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01928732
| Contact: Kristina L Caudle, PhD | (802) 296-5132 | Kristina.Caudle@va.gov |
| United States, Alabama | |
| Tuscaloosa VA Medical Center, Tuscaloosa, AL | Recruiting |
| Tuscaloosa, Alabama, United States, 35404 | |
| Contact: David W MacVicar, PhD 205-554-2000 ext 12971 David.MacVicar@va.gov | |
| United States, Arizona | |
| Phoenix VA Health Care System, Phoenix, AZ | Recruiting |
| Phoenix, Arizona, United States, 85012 | |
| Contact: Karen Kattar, PhD 602-277-5551 ext 2507 Karen.Kattar@va.gov | |
| United States, California | |
| VA Long Beach Healthcare System, Long Beach, CA | Recruiting |
| Long Beach, California, United States, 90822 | |
| Contact: Michael Hollifield, MD 562-826-8000 ext 4324 Michael.Hollifield@va.gov | |
| VA Palo Alto Health Care System, Palo Alto, CA | Recruiting |
| Palo Alto, California, United States, 94304-1290 | |
| Contact: Steven Lindley, MD 650-493-5000 ext 25189 Steven.Lindley@va.gov | |
| San Francisco VA Medical Center, San Francisco, CA | Recruiting |
| San Francisco, California, United States, 94121 | |
| Contact: John R McQuaid, PhD 415-221-4810 ext 4106 John.McQuaid@va.gov | |
| United States, Georgia | |
| Atlanta VA Medical and Rehab Center, Decatur, GA | Recruiting |
| Decatur, Georgia, United States, 30033 | |
| Contact: Millie Astin, PhD 404-321-6111 ext 5176 Millie.Astin@va.gov | |
| United States, Illinois | |
| Edward Hines Jr. VA Hospital, Hines, IL | Recruiting |
| Hines, Illinois, United States, 60141-5000 | |
| Contact: Kelly Phipps Maieritsch, PhD 708-202-8387 ext 21173 Kelly.Maieritsch@va.gov | |
| United States, Louisiana | |
| Southeast Louisiana Veterans Health Care System, New Orleans, LA | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Laurel Franklin, PhD 504-571-8294 Laurel.Franklin@va.gov | |
| United States, Minnesota | |
| Minneapolis VA Health Care System, Minneapolis, MN | Recruiting |
| Minneapolis, Minnesota, United States, 55417 | |
| Contact: Kyle Curry, PhD 612-467-5093 Kyle.Curry@va.gov | |
| United States, New Mexico | |
| New Mexico VA Health Care System, Albuquerque, NM | Recruiting |
| Albuquerque, New Mexico, United States, 87108-5153 | |
| Contact: Diane T Castillo, PhD 505-265-1711 ext 5857 Diane.Castillo@va.gov | |
| United States, North Carolina | |
| Durham VA Medical Center, Durham, NC | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Claire Collie, PhD 919-286-0411 ext 5633 Claire.Collie@va.gov | |
| United States, Ohio | |
| Cincinnati VA Medical Center, Cincinnati, OH | Recruiting |
| Cincinnati, Ohio, United States, 45220 | |
| Contact: Benjamin Dickstein, PhD 513-861-3100 Benjamin.Dickstein@va.gov | |
| Louis Stokes VA Medical Center, Cleveland, OH | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Kerry A Renner, PhD 216-791-3800 ext 6944 Kerry.Renner@va.gov | |
| United States, Texas | |
| Michael E. DeBakey VA Medical Center, Houston, TX | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Sara (Su) Bailey, PhD 713-794-7453 Su.Bailey@va.gov | |
| United States, Utah | |
| VA Salt Lake City Health Care System, Salt Lake City, UT | Recruiting |
| Salt Lake City, Utah, United States, 84148 | |
| Contact: Jennifer Romesser, PsyD 801-582-1565 ext 2711 Jennifer.Romesser@va.gov | |
| United States, Vermont | |
| White River Junction VA Medical Center, White River Junction, VT | Recruiting |
| White River Junction, Vermont, United States, 05009-0001 | |
| Contact: Kristina L Caudle, PhD 802-296-5132 Kristina.Caudle@va.gov | |
| Study Chair: Paula P Schnurr, PhD | |
| United States, Washington | |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Recruiting |
| Seattle, Washington, United States, 98108 | |
| Contact: Patrick Sylvers, PhD 253-583-1774 Patrick.Sylvers@va.gov | |
| United States, Wisconsin | |
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Michael Messina, PhD 608-256-1901 ext 17557 Michael.Messina2@va.gov | |
| Study Chair: | Paula P Schnurr, PhD | White River Junction VA Medical Center, White River Junction, VT |
| Study Chair: | Josef I Ruzek, PhD | VA Palo Alto Health Care System, Palo Alto, CA |
| Study Chair: | Kathleen M Chard, PhD | Cincinnati VA Medical Center, Cincinnati, OH |
More Information
Publications:
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT01928732 History of Changes |
| Other Study ID Numbers: |
591 |
| Study First Received: | August 16, 2013 |
| Last Updated: | June 1, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Additional relevant MeSH terms:
|
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on July 17, 2017