Comparative Effectiveness Research in Veterans With PTSD (CERV-PTSD)
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| ClinicalTrials.gov Identifier: NCT01928732 |
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Recruitment Status :
Completed
First Posted : August 27, 2013
Results First Posted : January 26, 2022
Last Update Posted : February 2, 2022
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| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | August 16, 2013 | |||||||||
| First Posted Date ICMJE | August 27, 2013 | |||||||||
| Results First Submitted Date ICMJE | September 14, 2021 | |||||||||
| Results First Posted Date ICMJE | January 26, 2022 | |||||||||
| Last Update Posted Date | February 2, 2022 | |||||||||
| Actual Study Start Date ICMJE | October 31, 2014 | |||||||||
| Actual Primary Completion Date | March 18, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 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.
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| Original Primary Outcome Measures ICMJE |
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.
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| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Comparative Effectiveness Research in Veterans With PTSD | |||||||||
| Official Title ICMJE | CSP #591 - CERV-PTSD: Comparative Effectiveness Research in Veterans With PTSD | |||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Post-Traumatic Stress Disorder | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
916 | |||||||||
| Original Estimated Enrollment ICMJE |
900 | |||||||||
| Actual Study Completion Date ICMJE | April 18, 2019 | |||||||||
| Actual Primary Completion Date | March 18, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | 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:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
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| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01928732 | |||||||||
| Other Study ID Numbers ICMJE | 591 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | VA Office of Research and Development | |||||||||
| Original Responsible Party | US Department of Veterans Affairs | |||||||||
| Current Study Sponsor ICMJE | VA Office of Research and Development | |||||||||
| Original Study Sponsor ICMJE | US Department of Veterans Affairs | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | |||||||||
| Verification Date | January 2022 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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