Comparative Effectiveness Research in Veterans With PTSD

Completed · Not applicable

Conditions studied: Post-Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT01928732

Run by

VA Office of Research and Development

People needed

916

Starts

2014-10-31

Expected to finish

2019-04-18

Last updated by the study team

2022-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, United States
• Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• Southeast Louisiana Veterans Health Care System, New Orleans, LA — New Orleans, Louisiana, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States
• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
• Cincinnati VA Medical Center, Cincinnati, OH — Cincinnati, Ohio, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
• VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
• White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States
• William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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