Comparative Effectiveness Research in Veterans With PTSD
- Conditions
- Post-Traumatic Stress Disorder
- Interventions
- Behavioral: Cognitive Processing Therapy (CPT)Behavioral: Prolonged Exposure (PE)
- Registration Number
- NCT01928732
- Lead Sponsor
- 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 (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.
- Detailed Description
VA Cooperative Study CSP #591 is designed to compare the effectiveness of Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) for treating posttraumatic stress disorder (PTSD) in male and female Veterans. PTSD is a serious and prevalent condition in Veterans, affecting just under 9% of VA patients in Fiscal Year 2011 (FY11). Since 2005, the number of VA patients with PTSD has increased 14.8% annually, due not only to new Veterans but also to increased numbers of Vietnam Veterans who are seeking care. In FY11, PTSD was the 3rd most common service-connected disability in VA.
Despite solid evidence that Prolonged Exposure and Cognitive Processing Therapy are effective treatments for PTSD in Veterans and non-Veterans, there is insufficient evidence about the effectiveness of these treatments relative to one another. The only study to compare the treatments, a single-site trial in non-Veteran female rape survivors, failed to find a difference, but the study was not adequately powered to compare two such effective treatments. Other data are similarly inconclusive. CSP #591 would break new ground as the first large-scale comparative effectiveness trial of treatment for PTSD and the first study to provide definitive information about how effective treatments for PTSD compare with one another.
The study will be a prospective randomized clinical trial with blinded assessment. The population will be male and female Veterans with PTSD due to any traumatic military event. Patients who are eligible and agree to participate in the study will be randomly assigned in a 1:1 ratio to receive Prolonged Exposure or Cognitive Processing Therapy. The investigators propose to administer 12 weekly sessions of each treatment as a standard "dose" but to allow participants who improve more rapidly to finish in 10 or 11 sessions and participants who have not attained adequate improvement by session 12 to have up to 2 additional sessions.
The primary outcome is improvement in PTSD symptom severity as measured by change on the Clinician-Administered PTSD Scale after treatment. The outcome measure will be determined from regular follow-up visits of the patients, which will occur at the middle and at the end of treatment and then 3 and 6 months later. Secondary outcomes include other measures of PTSD, comorbid mental health problems, functioning, quality of life, and service utilization. The investigators also will measure participants' treatment preference and examine whether concordance between preference and allocation is associated with increased treatment effectiveness.
In order to detect a standardized mean difference in improvement in PTSD symptom severity of d = .25, a sample size of 900 randomized patients provides 90% power to detect a difference between arms using the linear mixed effects model with a two-sided = .05. Given the lack of conclusive findings to predict which treatment is better, the investigators propose to test a nondirectional hypothesis. Assuming 2.5 years of accrual and an enrollment of 26 participants per year at each site, the investigators would need 14.1 sites to enroll a total of 64 participants per site. The investigators propose to recruit 17 sites to guard against the possibility that some sites will not enroll the required number of participants.
VA has a vested interest in understanding the relative effectiveness of Prolonged Exposure and Cognitive Processing Therapy. Both treatments are recommended at the highest level in the Veterans Affairs (VA)/Department of Defense (DoD) PTSD Practice Guideline. VA is required to make these treatments available to Veterans seeking PTSD care. The treatments are being disseminated nationally across the VA system in order to enhance the availability of evidence-based treatments to Veterans with PTSD. VA also has developed a national PTSD Mentoring Program for PTSD Program Administrators to help them manage their clinics to permit the delivery of these treatments. Every facility has an evidence-based therapy coordinator as well to facilitate training in evidence-based psychotherapy.
As a large multi-site trial with men and women, CSP #591 would provide definitive information about the comparative effectiveness of Prolonged Exposure and Cognitive Processing Therapy and maximize the study's impact on the field. Because the treatments are based on differing theories about the development of PTSD, a demonstration that one treatment is superior to the other would further scientific exploration by challenging theoretical accounts of etiology and treatment. Regardless of which treatment is better, patients would have more information to help them make an informed decision about which treatment to choose and VA would have stronger evidence to help make care Veteran-centered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 916
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPT Cognitive Processing Therapy (CPT) Cognitive Processing Therapy (CPT) - a type of cognitive therapy for treating PTSD. PE Prolonged Exposure (PE) Prolonged Exposure (PE) - a type of exposure therapy for treating PTSD.
- Primary Outcome Measures
Name Time Method Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS) immediate post-treatment, 3 and 6 months The primary outcome is the change of CAPS-5 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. Possible range for CAPS-5 total score 0-80. Higher score indicates more severe PTSD.
- Secondary Outcome Measures
Name Time Method Posttraumatic Diagnostic Scale (PDS-5) immediate post-treatment, 3 and 6 months The PDS-5 is a 24-item self-report measure that assesses PTSD symptom severity in the last month according to DSM-5 criteria. The outcome is the change of PDS-5 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). Possible range for PDS-5 score 0-80. Higher PDS-5 Score indicates more severe PTSD Symptoms.
Brief Addiction Monitor (BAM) immediate post-treatment, 3 and 6 months The BAM measures an individual's health, alcohol, and drug use. The outcome is the change of BAM 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). Range: 0-4 points. Higher score indicates worse outcome (i.e., more severe addiction).
Beck Depression Inventory-II (BDI-II) immediate post-treatment, 3 and 6 months BDI-II is a brief, self-report inventory designed to measure the severity of depression symptomatology. The outcome is the change of BDI-II 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). Possible range for BDI-II 0-63. Higher score indicates more severe depressive symptoms (0-13 minimal, 14-29 mild, 20-28 moderate, 29-63 severe).
Short Inventory of Problems - Revised (SIP-R) immediate post-treatment, 3 and 6 months The SIP-R assesses alcohol-related consequences. The outcome is the change of SIP-R 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). Possible range for SIP-R 0-51. Higher score indicates more severe adverse consequences of substance use.
Spielberger State Anger Inventory (STAXI) immediate post-treatment, 3 and 6 months The STAXI is a commonly used measure of trait and state anxiety. The outcome is the change of STAI 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). Possible range for STAXI 44-176. Higher score indicates greater intensity of anger.
World Health Organization Quality of Life (WHOQoL-BREF) immediate post-treatment, 3 and 6 months The WHOQoL-BREF is a quality of life assessment. The outcome is the change of WHOQoL-BREF assessment sub-category (Physical Health, Psychological, Social Relationships, Environment) scores 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). Possible range for WHOQOL-BREF 0-100, Physical Health 0-100, Psychological 0-100, Social Relationships 0-100, and Environment 0-100. Higher score indicates better satisfaction with life.
World Health Organization Disability Assessment Schedule (WHO-DAS-II) immediate post-treatment, 3 and 6 months The WHO-DAS-II is an assessment instrument for health and disability. The outcome is the change of WHO-DAS-II 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). Possible range for WHODAS-II 12-60. Higher score indicates more difficulty and disability due to health condition.
Trial Locations
- Locations (18)
New Mexico VA Health Care System, Albuquerque, NM
🇺🇸Albuquerque, New Mexico, United States
Edward Hines Jr. VA Hospital, Hines, IL
🇺🇸Hines, Illinois, United States
VA Palo Alto Health Care System, Palo Alto, CA
🇺🇸Palo Alto, California, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
🇺🇸Decatur, Georgia, 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 Puget Sound Health Care System Seattle Division, Seattle, WA
🇺🇸Seattle, Washington, United States
VA Long Beach Healthcare System, Long Beach, CA
🇺🇸Long Beach, California, United States
White River Junction VA Medical Center, White River Junction, VT
🇺🇸White River Junction, Vermont, United States
Southeast Louisiana Veterans Health Care System, New Orleans, LA
🇺🇸New Orleans, Louisiana, United States
Phoenix VA Health Care System, Phoenix, AZ
🇺🇸Phoenix, Arizona, United States
San Francisco VA Medical Center, San Francisco, CA
🇺🇸San Francisco, California, United States
Minneapolis VA Health Care System, Minneapolis, MN
🇺🇸Minneapolis, Minnesota, United States
Durham VA Medical Center, Durham, NC
🇺🇸Durham, North Carolina, United States
Cincinnati VA Medical Center, Cincinnati, OH
🇺🇸Cincinnati, Ohio, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
🇺🇸Salt Lake City, Utah, United States
Tuscaloosa VA Medical Center, Tuscaloosa, AL
🇺🇸Tuscaloosa, Alabama, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
🇺🇸Madison, Wisconsin, United States