Adapted Cognitive Processing Therapy for PTSD
(CPT MOST Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Must be taking: Psychotropic
Disqualifiers: Active suicidality, Need for detoxification, Severe cognitive impairment, Psychosis, Unmanaged bipolar, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?Cognitive Processing Therapy (CPT) consists of discrete therapeutic components that are delivered across 12 sessions, but most Veterans never reach session 12, and those who drop out receive only 4 sessions on average. Veterans drop out because of time constraints, logistics, and lack of perceived benefit. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT and continue to experience symptom-related distress and numerous other negative outcomes, including lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide.
The overall objective of this study is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you have been on a stable dose of any psychotropic medication for at least 4 weeks before joining.
What data supports the effectiveness of the treatment Cognitive Processing Therapy (CPT) for PTSD?
Research shows that Cognitive Processing Therapy (CPT) is effective in reducing PTSD symptoms, especially in veterans and trauma survivors, with many studies indicating significant improvements in patients' conditions. The therapy has been widely adopted by the Department of Veterans Affairs and has shown positive outcomes in both fixed and variable-length formats, with many patients experiencing a reduction in PTSD symptoms.
12345Is cognitive processing therapy (CPT) safe for humans?
Cognitive processing therapy (CPT) is widely regarded as a safe treatment for post-traumatic stress disorder (PTSD) and has been implemented in various settings, including the Department of Veterans Affairs, without significant safety concerns reported.
12467How is Cognitive Processing Therapy (CPT) different from other PTSD treatments?
Cognitive Processing Therapy (CPT) is unique because it focuses on changing faulty beliefs and interpretations related to trauma through a structured protocol of education, exposure, and cognitive components, typically delivered in 12 sessions. It is effective for various groups, including sexual assault survivors and military veterans, and can be adapted for different settings and populations.
24789Eligibility Criteria
This trial is for Veterans over 18 with PTSD treated in PCTs, stable on psychotropic meds for at least 8 weeks, and scoring above 33 on the PCL-5. It's not for those with severe cognitive issues, psychosis or unmanaged bipolar disorder, recent CPT treatment, current detox needs, ongoing trauma-focused therapy, or acute suicide risk.Inclusion Criteria
Score of 33 or above on the PCL-5
I am over 18 years old.
I have been on the same dose of my mental health medication for at least 8 weeks.
+1 more
Exclusion Criteria
Need for detoxification
I am currently in therapy for trauma (PE or CPT).
Psychosis or unmanaged bipolar disorder
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Cognitive Processing Therapy (CPT) components in a brief format to improve efficiency and reduce dropout rates.
6 weeks
12 sessions (in-person or virtual)
Follow-up
Participants are monitored for PTSD symptom reduction and overall effectiveness of the adapted CPT intervention.
6 months
3 visits (in-person or virtual) at 6-week, 3-month, and 6-month intervals
Participant Groups
The study aims to adapt Cognitive Processing Therapy (CPT) into a shorter format by identifying and delivering only its most effective components. This could reduce dropouts due to time constraints or lack of benefit and ensure that Veterans receive the best parts of CPT more efficiently.
16Treatment groups
Active Control
Group I: 10Active Control3 Interventions
Core Session 1, Core Session 2, Modified A-B-C , Challenging Beliefs, Module Choice, Final Session
Group II: 4Active Control3 Interventions
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Module Choice, Final Session
Group III: 11Active Control3 Interventions
Core Session 1, Core Session 2, Challenging Questions, Challenging Beliefs, Module Choice, Final Session
Group IV: 14Active Control3 Interventions
Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Challenging Beliefs, Final Session
Group V: 13Active Control3 Interventions
Core Session 1, Core Session 2, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session
Group VI: 16Active Control5 Interventions
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session
Group VII: 7Active Control3 Interventions
Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Module Choice, Final Session
Group VIII: 2Active Control1 Intervention
Core Session 1, Core Session 2, Modified A-B-C, Final Session
Group IX: 3Active Control1 Intervention
Core Session 1, Core Session 2, Challenging Questions, Final Session
Group X: 5Active Control1 Intervention
Core Session 1, Core Session 2, Problematic Patterns, Final Session
Group XI: 6Active Control3 Interventions
Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Module Choice, Final Session
Group XII: 8Active Control3 Interventions
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Final Session
Group XIII: 9Active Control1 Intervention
Core Session 1, Core Session 2, Challenging Beliefs, Final Session
Group XIV: 12Active Control3 Interventions
Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Challenging Beliefs, Final Session
Group XV: 15Active Control3 Interventions
Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Challenging Beliefs, Final Session
Group XVI: 1Active Control1 Intervention
Core Session 1, Core Session 2, Module Choice, Final Session
Cognitive Processing Therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Cognitive Processing Therapy for:
- Posttraumatic Stress Disorder (PTSD)
🇪🇺 Approved in European Union as Cognitive Processing Therapy for:
- Posttraumatic Stress Disorder (PTSD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, UT
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn Arbor, MI
Cincinnati VA Medical Center, Cincinnati, OHCincinnati, OH
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Dissemination and experience with cognitive processing therapy. [2022]Clinical practice guidelines suggest that cognitive behavioral therapies are recommended for the treatment of posttraumatic stress disorder (PTSD). One of these treatments, cognitive processing therapy (CPT), is an evidence-based treatment that has been shown to be effective at treating combat, assault, and interpersonal violence trauma in randomized controlled trials. The Department of Veterans Affairs (VA) Office of Mental Health Services has implemented an initiative to disseminate CPT as part of a broad effort to make evidence-based psychotherapies widely available throughout the VA healthcare system. This article provides an overview of CPT and reviews the efficacy and program evaluation data supporting its use in a variety of settings. In addition, we report on survey data from individuals who have participated in the VA initiative and on outcome data from patients treated by rollout-trained therapists. Our data suggest that many clinicians trained in the rollout show good adoption of the CPT model and demonstrate solid improvements in their patients' PTSD and depressive symptomotology. Finally, we offer recommendations for using CPT in clinical settings.
Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. [2019]Cognitive processing therapy (CPT) is an exposure-based protocol designed to reduce posttraumatic stress disorder (PTSD) symptoms and challenge faulty beliefs and interpretations that prevent trauma survivors from coming to terms with their traumatic experiences. This article provides a brief summary of this treatment and the related literature and describes how the CPT protocol was modified to implement this treatment in this study's setting. Also provided is a discussion of various institutional and intrapatient barriers that existed before the introduction of CPT and how these difficulties were ultimately resolved. Patients' responses to treatment, as indicated by both qualitative and quantitative data, are also reviewed. A total of 18 patients participated and completed treatment with CPT (50% Caucasian, 22.2% African American, 16.7% biracial, 5.6% Native American, and 5.6% Hispanic). Overall, the women participating in the protocol benefited greatly, and 15 of the 18 women had a statistically significant reduction in scores measuring PTSD symptoms. The article concludes with recommendations to other programs and providers interested in providing CPT to similar treatment populations. (PsycINFO Database Record (c) 2010 APA, all rights reserved).
Variable-length Cognitive Processing Therapy for posttraumatic stress disorder in active duty military: Outcomes and predictors. [2021]Cognitive Processing Therapy (CPT) is an evidence-based therapy recommended for posttraumatic stress disorder (PTSD). However, rates of improvement and remission are lower in veterans and active duty military compared to civilians. Although CPT was developed as a 12-session therapy, varying the number of sessions based on patient response has improved outcomes in a civilian study. This paper describes outcomes of a clinical trial of variable-length CPT among an active duty sample. Aims were to determine if service members would benefit from varying the dose of treatment and identify predictors of treatment length needed to reach good end-state (PTSD Checklist-5 ≤ 19). This was a within-subjects trial in which all participants received CPT (N = 127). Predictor variables included demographic, symptom, and trauma-related variables; internalizing/externalizing personality traits; and readiness for change. Varying treatment length resulted in more patients achieving good end-state. Best predictors of nonresponse or needing longer treatment were pretreatment depression and PTSD severity, internalizing temperament, being in precontemplation stage of readiness for change, and African American race. Controlling for differences in demographics and initial PTSD symptom severity, the outcomes using a variable-length CPT protocol were superior to the outcomes of a prior study using a fixed, 12-session CPT protocol. CLINICALTRIALS.GOV IDENTIFIER: NCT023818.
Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. [2023]Approximately ten percent of US military veterans suffer from posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) is a highly effective, evidence-based, first-line treatment for PTSD that has been widely adopted by the Department of Veterans Affairs (VA). CPT consists of discrete therapeutic components delivered across 12 sessions, but most veterans (up to 70%) never reach completion, and those who discontinue therapy receive only four sessions on average. Unfortunately, veterans who drop out prematurely may never receive the most effective components of CPT. Thus, there is an urgent need to use empirical approaches to identify the most effective components of CPT so CPT can be adapted into a briefer format.
Predicting response to cognitive processing therapy: Does trauma history matter? [2022]Cognitive processing therapy (CPT) has reliably demonstrated efficacy for the treatment of posttraumatic stress disorder (PTSD) for most patients, however, not all patients derive the same benefit from CPT. The aim of the present study is to identify trauma-related variables that predict differential response to CPT in a sample of treatment-seeking veterans in order to improve individual responses to CPT.
Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study. [2019]Cognitive processing therapy (CPT) is widely regarded as a safe and effective first-line treatment for individuals with post-traumatic stress disorder (PTSD); however, no comparative studies have been conducted to examine the treatment outcomes in an Asian population. The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients.
Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. [2022]Cognitive processing therapy (CPT), an evidence-based treatment for posttraumatic stress disorder (PTSD), has not been tested as an individual treatment among active-duty military. Group CPT may be an efficient way to deliver treatment.
Cognitive processing therapy for sexual assault victims. [2022]Cognitive processing therapy (CPT) was developed to treat the symptoms of posttraumatic stress disorder (PTSD) in rape victims. CPT is based on an information processing theory of PTSD and includes education, exposure, and cognitive components. Nineteen sexual assault survivors received CPT, which consists of 12 weekly sessions in a group format. They were assessed at pretreatment, posttreatment, and 3- and 6-month follow-up. CPT subjects were compared with a 20-subject comparison sample, drawn from the same pool who waited for group therapy for at least 12 weeks. CPT subjects improved significantly from pre- to posttreatment on both PTSD and depression measures and maintained their improvement for 6 months. The comparison sample did not change from the pre- to the posttreatment assessment sessions.
Effect of therapeutic competence, adherence, and alliance on treatment outcome in youth with PTSD treated with developmentally adapted cognitive processing therapy. [2023]Developmentally adapted cognitive processing therapy (D-CPT) is an effective treatment for posttraumatic stress disorder (PTSD) in adolescents and young adults. It is unclear if therapeutic adherence and competence in D-CPT are associated with higher PTSD treatment gains.