Post-Traumatic Stress DisorderCERV-PTSDNCT01928732
Comparative Effectiveness Research in Veterans With PTSD
A study testing Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) in people with Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 916 participants
- Where
- 18 sitesUnited States
- Study dates
- 31 Oct 2014to 18 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70112
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05009-0001
About this study
Official title: CSP #591 - CERV-PTSD: Comparative Effectiveness Research in Veterans With PTSD
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.
Read the 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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Cognitive Processing Therapy (CPT), Prolonged Exposure (PE)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing Therapy (CPT)Behavioural
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.
Prolonged Exposure (PE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CPT | Active comparator | Cognitive Processing Therapy (CPT) - a type of cognitive therapy for treating PTSD. Receives: Behavioral: Cognitive Processing Therapy (CPT) |
| PE | Active comparator | Prolonged Exposure (PE) - a type of exposure therapy for treating PTSD. Receives: Behavioral: Prolonged Exposure (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS)
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.
Measured: immediate post-treatment, 3 and 6 months
Secondary outcomes (7)
Posttraumatic Diagnostic Scale (PDS-5)
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.
Measured: immediate post-treatment, 3 and 6 months
Beck Depression Inventory-II (BDI-II)
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).
Measured: immediate post-treatment, 3 and 6 months
Spielberger State Anger Inventory (STAXI)
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.
Measured: immediate post-treatment, 3 and 6 months
Short Inventory of Problems - Revised (SIP-R)
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.
Measured: immediate post-treatment, 3 and 6 months
Brief Addiction Monitor (BAM)
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).
Measured: immediate post-treatment, 3 and 6 months
World Health Organization Disability Assessment Schedule (WHO-DAS-II)
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.
Measured: immediate post-treatment, 3 and 6 months
World Health Organization Quality of Life (WHOQoL-BREF)
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.
Measured: immediate post-treatment, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study start31 Oct 2014
- Primary completion18 Mar 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 916 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paula P Schnurr, PhD, Study chair, White River Junction VA Medical Center, White River Junction, VTJosef I Ruzek, PhD, Study chair, VA Palo Alto Health Care System, Palo Alto, CAKathleen M Chard, PhD, Study chair, Cincinnati VA Medical Center, Cincinnati, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928732
- Sponsor's protocol ID
- 591
- Acronym
- CERV-PTSD
- Status last verified
- Jan 2022
- First submitted
- 16 Aug 2013
- Last updated
- 2 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih MC, Resick PA, Foa EB, Marx BP, Huang GD, Lu Y. Corrigendum to "Design of VA Cooperative Study #591: CERV-PTSD, Comparative Effectiveness Research in Veterans with PTSD" [Contemp. Clin. Trials 41 (2015) 75-84]. Contemp Clin Trials. 2019 May;80:61. doi: 10.1016/j.cct.2019.04.003. Epub 2019 Apr 5. No abstract available.
PubMed 30962124Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih MC, Resick PA, Foa EB, Marx BP, Huang GD, Lu Y. Design of VA Cooperative Study #591: CERV-PTSD, comparative effectiveness research in veterans with PTSD. Contemp Clin Trials. 2015 Mar;41:75-84. doi: 10.1016/j.cct.2014.11.017. Epub 2014 Nov 29.
PubMed 25457792Schnurr PP, Chard KM, Ruzek JI, Chow BK, Resick PA, Foa EB, Marx BP, Friedman MJ, Bovin MJ, Caudle KL, Castillo D, Curry KT, Hollifield M, Huang GD, Chee CL, Astin MC, Dickstein B, Renner K, Clancy CP, Collie C, Maieritsch K, Bailey S, Thompson K, Messina M, Franklin L, Lindley S, Kattar K, Luedtke B, Romesser J, McQuaid J, Sylvers P, Varkovitzky R, Davis L, MacVicar D, Shih MC. Comparison of Prolonged Exposure vs Cognitive Processing Therapy for Treatment of Posttraumatic Stress Disorder Among US Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2136921. doi: 10.1001/jamanetworkopen.2021.36921.
PubMed 35044471Moshier SJ, Mahoney CT, Bovin MJ, Marx BP, Schnurr PP. Session-level effects of cognitive processing therapy and prolonged exposure on individual symptoms of posttraumatic stress disorder among U.S. veterans. J Consult Clin Psychol. 2024 Jul;92(7):422-431. doi: 10.1037/ccp0000880. Epub 2024 Mar 28.
PubMed 38546622
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #591 - CERV-PTSD: Comparative Effectiveness Research in Veterans With PTSD
- ClinicalTrials.gov ID
- NCT01928732
- Acronym / sponsor ID
- CERV-PTSD / 591
- Conditions
- Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 916 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 Oct 2014 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Posted 26 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPT | Active comparator | Behavioral: Cognitive Processing Therapy (CPT)Cognitive Processing Therapy (CPT) - a type of cognitive therapy for treating PTSD. |
| PE | Active comparator | Behavioral: Prolonged Exposure (PE)Prolonged Exposure (PE) - a type of exposure therapy for treating PTSD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CPT |
| 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. | Behavioural | PE |
Primary outcome
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.
7 secondary outcomes
Posttraumatic Diagnostic Scale (PDS-5)
Time frame: immediate post-treatment, 3 and 6 months
Beck Depression Inventory-II (BDI-II)
Time frame: immediate post-treatment, 3 and 6 months
Spielberger State Anger Inventory (STAXI)
Time frame: immediate post-treatment, 3 and 6 months
Short Inventory of Problems - Revised (SIP-R)
Time frame: immediate post-treatment, 3 and 6 months
Brief Addiction Monitor (BAM)
Time frame: immediate post-treatment, 3 and 6 months
World Health Organization Disability Assessment Schedule (WHO-DAS-II)
Time frame: immediate post-treatment, 3 and 6 months
World Health Organization Quality of Life (WHOQoL-BREF)
Time frame: immediate post-treatment, 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30962124Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih MC, Resick PA, Foa EB, Marx BP, Huang GD, Lu Y. Corrigendum to "Design of VA Cooperative Study #591: CERV-PTSD, Comparative Effectiveness Research in Veterans with PTSD" [Contemp. Clin. Trials 41 (2015) 75-84]. Contemp Clin Trials. 2019 May;80:61. doi: 10.1016/j.cct.2019.04.003. Epub 2019 Apr 5. No abstract available.
- Background: PubMed 25457792Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih MC, Resick PA, Foa EB, Marx BP, Huang GD, Lu Y. Design of VA Cooperative Study #591: CERV-PTSD, comparative effectiveness research in veterans with PTSD. Contemp Clin Trials. 2015 Mar;41:75-84. doi: 10.1016/j.cct.2014.11.017. Epub 2014 Nov 29.
- Results publication: PubMed 35044471Schnurr PP, Chard KM, Ruzek JI, Chow BK, Resick PA, Foa EB, Marx BP, Friedman MJ, Bovin MJ, Caudle KL, Castillo D, Curry KT, Hollifield M, Huang GD, Chee CL, Astin MC, Dickstein B, Renner K, Clancy CP, Collie C, Maieritsch K, Bailey S, Thompson K, Messina M, Franklin L, Lindley S, Kattar K, Luedtke B, Romesser J, McQuaid J, Sylvers P, Varkovitzky R, Davis L, MacVicar D, Shih MC. Comparison of Prolonged Exposure vs Cognitive Processing Therapy for Treatment of Posttraumatic Stress Disorder Among US Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2136921. doi: 10.1001/jamanetworkopen.2021.36921.
- Derived from this study: PubMed 38546622Moshier SJ, Mahoney CT, Bovin MJ, Marx BP, Schnurr PP. Session-level effects of cognitive processing therapy and prolonged exposure on individual symptoms of posttraumatic stress disorder among U.S. veterans. J Consult Clin Psychol. 2024 Jul;92(7):422-431. doi: 10.1037/ccp0000880. Epub 2024 Mar 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula P Schnurr, PhD study chair
White River Junction VA Medical Center, White River Junction, VT
Josef I Ruzek, PhD study chair
VA Palo Alto Health Care System, Palo Alto, CA
Kathleen M Chard, PhD study chair
Cincinnati VA Medical Center, Cincinnati, OH
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) in people with Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS) (time frame: immediate post-treatment, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928732, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.