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Comparative Effectiveness Research in Veterans With PTSD (CERV-PTSD)

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ClinicalTrials.gov Identifier: NCT01928732
Recruitment Status : Active, not recruiting
First Posted : August 27, 2013
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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 or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Cognitive Processing Therapy (CPT) Behavioral: Prolonged Exposure (PE) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CSP #591 - CERV-PTSD: Comparative Effectiveness Research in Veterans With PTSD
Actual Study Start Date : October 31, 2014
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928732


Locations
United States, Alabama
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404
United States, Arizona
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
United States, California
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
United States, Louisiana
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, United States, 70112
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
United States, New Mexico
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States, 87108-5153
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States, 45220
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148
United States, Vermont
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, United States, 05009-0001
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01928732     History of Changes
Other Study ID Numbers: 591
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
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