VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Study documents. Data generated by this study will not be made available.

Available Documentation

• Study Protocol (pdf)
• Statistical Analysis Plan (pdf)
• Informed Consent Form (pdf)

Dates Data are Available

Upon completion of study objectives

Access Criteria

Documentation available on study ClinicalTrials.gov site

Study Characteristics

Objectives

• The primary objective is to compare the effectiveness of Prolonged Exposure (PE) and Cognitive Processing Therapy (CPT) for reducing the severity of PTSD symptoms.
• The secondary objective is to compare the effectiveness of PE and CPT for reducing the severity of comorbid mental health problems and service utilization and improving functioning and quality of life.
• The tertiary objective is to examine whether discrepancy between patient preferences and treatment assignments reduces the effectiveness of each treatment.

Exploratory analyses will examine whether demographic and clinical characteristics predict differential response to PE and CPT.

Era of Service

All

Population

Male and female Veterans with PTSD due to any military event.

Inclusion:

• Current PTSD and symptom severity of DSM-V equivalent of ≥ on the DSM-IV Clinician-Administered PTSD Scale
• Agreement to not receive psychotherapy for PTSD during study treatment
• Allow digital recording of phone interviews and therapy
• Regular access to telephone (or agreement to come to the VA for centrally conducted telephone interviews for participants who do not have telephone access)
• On stable regimen (no dose or medication change) for 30 days prior to study entry for those taking psychoactive medication

Exclusion:

• Substance dependence not in remission for at least 1 month
• Current psychotic symptoms or mania (or manic phase of bipolar disorder)
• Significant current suicidal or homicidal ideation that include a specific plan
• Moderate to severe cognitive impairment defined as 1 SD below age-graded norms on the Montreal Cognitive Assessment (MoCA)
• Currently incarcerate or those who become incarcerated during the course of participation

Study Design

Randomized, parallel assignment

Intervention

Arm 1: Cognitive Processing Therapy (CPT)

Arm 2: Prolonged Exposure (PE)

Time Period

October 2014 – April 2019

Setting

National

N

916 participants

Response Rate

Unconfirmed

Recruitment Methods

• VA specialty and general mental health clinics
• Primary care deployment health clinics
• Vet Centers
• Community via presentations
• Advertisements
• Networking with Veteran groups
• Direct contacts
• Referrals

Compensation

Maximum compensation: $410

• Screening/baseline/interview $30/20/50
• Mid-treatment $50
• Posttreatment $75
• 3-month follow-up $85
• 6-month follow-up $100

Participants were also reimbursed for travel over 50 miles.

Data Collected

• Posttraumatic stress disorder
• Patient health
• Anger
• Addiction
• Inventory of problems
• Disability
• Quality of life
• Client satisfaction
• Treatment preference
• Expectancy of therapeutic outcomes
• Service utilization
• Mental disorders
• Cognitive assessment
• Demographics
• Traumatic brain injury
• Military sexual trauma
• Life events
• Depression

Data Collection Methods

• Clinically administered research data forms
• Self-reported questionnaires

Funding Source

VA Cooperative Studies Program (CSP)

Investigators

• Paula P. Schnurr, PhD
• Kathleen M. Chard, PhD
• Josef l. Ruzek, PhD

Contact

Unconfirmed

Selected Publications

Schnurr 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

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.

Schnurr 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. Erratum in: Contemp Clin Trials. 2019 May;80:61.

More Information

Study ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT01928732