CF-CPTNCT04407767

A Case Formulation Approach to Cognitive Processing Therapy

StatusCompleted

PhaseNot applicable

SponsorVA Office of Research and Development

Primary completionJul 22, 2025

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Record History

All 13 versions: 10 with changes below, 3 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Oct 26, 2026 Results posted: Oct 29, 2026 Show 5 more changesShow less
- Primary endpoints: 2 to 1
- Enrollment target: 179 to 194
- Secondary endpoints: 21 to 19
- Study description revised
- Eligibility criteria expanded, about 3 words
Minor Mar 23, 2026 Trial status: Active, Not Recruiting to Completed
- Primary completion date: Mar 31, 2025 to Jul 22, 2025
- Study completion date changed from estimate of Sep 1, 2026 to Aug 1, 2025
v12
Minor Sep 16, 2025 Enrollment target: 180 to 179
- Study completion date: Sep 30, 2025 to Sep 1, 2026
v11
Notable Oct 9, 2024 Primary completion date: Sep 30, 2024 to Mar 31, 2025v8 Show 4 more changesShow less
- Trial status: Recruiting to Active, Not Recruiting
- Enrollment target: estimated 256 to confirmed 180
- Study completion date: Aug 31, 2025 to Sep 30, 2025
- Site details revised at 8 of 8 sites
Notable Feb 15, 2024 Primary completion date: Feb 28, 2024 to Sep 30, 2024
- Study completion date: Sep 30, 2024 to Aug 31, 2025
v7

Show 4 earlier versionsHide 4 earlier versions

Minor Mar 7, 2023 Primary completion date: Dec 29, 2023 to Feb 28, 2024
- Site details revised at 7 of 8 sites
v6
Minor Apr 1, 2022 Study sites: 2 to 8
- Secondary endpoints revised (21)
v5
Notable Mar 26, 2021 Trial status: Not Yet Recruiting to Recruiting
- Site details revised at 2 of 2 sites
v4
Notable Jan 21, 2021 Start date: Jan 4, 2021 to Mar 15, 2021v3

May 27, 2020 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Inventory of Psychosocial Functioning (Assessing Change Over Time)

Timeframe: Assesses functioning at baseline assessment, at session 6 during treatment (approximately Week 8), after treatment (post-treatment; approximately Week 16), and at the 3-month follow-up interval (anchored to post-treatment assessment; ~Week 28).

Secondary (19)

Clinician-Administered PTSD Scale-5 (CAPS) (Assessing Change Over Time)

WHO - Disability Assessment Schedule 2.0 (WHODAS-II) (Assessing Change Over Time)

WHO - Quality of Life - Brief (Assessing Change Over Time)

Well-Being Inventory (WBI) (Assessing Change Over Time)

PTSD Checklist-DSM-5 (PCL-5) (Assessing Change Over Time)

Show 14 moreShow less

Patient Health Questionnaire - 9 (Assessing Change Over Time)

Session Progress Notes (Assessing Change Over Time)

DSM-5 Cross-cutting Symptom Measure (CCSM) (Assessing Change Over Time)

Weekly Stress Inventory (Assessing Change Over Time)

Veterans Rand Short Form (Assessing Change Over Time)

Pittsburgh Sleep Quality Index (PSQI) (Assessing Change Over Time)

PEG Measure (Assessing Change Over Time)

State-Trait Anxiety Inventory (Assessing Change Over Time)

Emotional Reactivity and Numbing Scale (Assessing Change Over Time)

Dimensions of Anger Reactions (Assessing Change Over Time)

Beck Suicidal Ideation Scale (Assessing Change Over Time)

Brief Addiction Monitor (Assessing Change Over Time)

University of Rhode Island Change Assessment (Assessing Change Over Time)

Daily Monitoring Diary (Assessing Change Over Time)

Arms and interventions

Case Formulation plus Cognitive Processing TherapyExperimental

The CF approach alters the CPT protocol in two ways: expanding the protocol to intentionally and systematically address impairment in functioning, and enhancing the providers' latitude to navigate challenges to optimal therapy outcomes (COTOS). CF-CPT begins with a formal CF assessment session; elements of CF are then integrated throughout CPT. CF modifications to the original CPT protocol occur in each session by intentionally attending to cognitions that are impeding the patient's functional recovery. The second modification includes enhancing the provider's latitude to diverge from the protocol when clinically wise. CF-CPT provides guidance around the identification, monitoring and management of COTOs, and, importantly, the expedient return to the CPT protocol with continued attention to COTOs.

Cognitive Processing TherapyActive comparator

CPT is a brief therapy for PTSD predominantly based on cognitive theory. Traditionally delivered over 12 one-hour sessions weekly or twice weekly, CPT is now variable length depending on patient's recovery from PTSD. CPT is delivered in three phases: education, processing, and challenging and focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Changing dysfunctional beliefs alters negative emotions emanating from those beliefs.

Behavioral: Case Formulation plus Cognitive Processing Therapy, Cognitive Processing Therapy

Sites

8 sites in 1 country

About this trial

Recent estimates suggest that over 610,000 US Veterans treated by the Veterans Health Administration (VHA) suffer from PTSD, a disorder that can be chronic and debilitating. The heterogeneity of the 20 symptoms of PTSD; comorbidity with disorders such as depression, panic, and substance use; high rates of lingering effects of physical injury; and suicidality all contribute to complex clinical presentations and can exact a significant toll on functioning, quality of life, and well-being even decades after exposure to the traumatic event. Perhaps spurred by the President's New Freedom Commission on Mental Health, psychosocial rehabilitation has shifted from the periphery in mental health recovery models to a more primary focus in clinical settings, including recommendations for use of psychosocial rehabilitation techniques in trauma-focused mental health care. Support for the efficacy of psychosocial rehabilitation techniques in PTSD recovery programs has burgeoned in recent years and data supporting psychological treatments for PTSD has increased exponentially, yet the two approaches to recovery have largely remained independent. Cognitive Processing Therapy (CPT), the evidence-based psychotherapy (EBP) for PTSD most frequently delivered within VHA, yields large magnitude reductions in primary PTSD outcomes. Corresponding gains in occupational, social, leisure, and sexual functioning, and in health-related concerns have also been demonstrated. Despite CPT's effectiveness, there is room for improvement in overall outcomes and patient engagement. Further, improvements in functioning and quality of life are more modest than those observed in PTSD and associated mental health symptoms. Prior work suggests that unaddressed difficulties in functioning contribute to premature dropout from EBPs for PTSD among Veterans. Directly targeting impairments associated with psychosocial functioning has the potential to substantially increase the scope of recovery beyond the core symptoms of PTSD and facilitate greater patient engagement, resulting in more Veterans benefitting from CPT. Modifying the CPT protocol to personalize the intervention for the individual patient has resulted in better overall response rates for a wider variety of patient populations suffering from complicated clinical presentations. Case formulation (CF) is a well-established approach to cognitive-behavioral treatment that facilitates a collaborative process between providers and patients to guide the tailoring of treatment to meet idiosyncratic patient needs. Integrating CF strategies into the existing CPT protocol will enable providers to personalize CPT to directly address impairment in functioning as well as provide the latitude to directly intervene with the complex challenges that threaten optimal outcomes within the context of trauma-focused therapy. CF-integrated CPT (CF-CPT) expands and enhances the CPT protocol to facilitate a personalized and flexible approach to treating PTSD that prioritizes the administration of the full dose of CPT while expanding the protocol to directly target important domains of functioning and result in more holistic outcomes. This controlled treatment outcome trial will randomize a national sample of CPT providers (Veteran n = 200; provider n = 50) to either deliver CF-CPT or CPT to compare the relative effectiveness of CF-CPT to CPT in improving primary outcomes, including Veterans' psychosocial functioning, quality of life and well-being over the course of treatment and 3-month follow-up as compared to Veterans who receive standard CPT. Further, Veterans who receive CF-CPT will demonstrate greater reductions in PTSD and depression over the course of treatment and 3-month follow-up than those who receive CPT. This study also seeks to determine the effectiveness of CF-CPT as compared to CPT in improving Veterans' treatment engagement (CF-CPT will demonstrate higher rates of Veteran treatment completion than CPT). This study will valuate CF-CPT's indirect impact on Veterans' psychosocial functioning and PTSD/depression symptomology Change in functioning, quality of life, and well-being \& PTSD and depression will be associated with improvement in the idiosyncratic clinical challenges targeted by the CF. This study will also examine between-group differences across secondary outcomes (e.g. anger, anxiety, health concerns, sleep, numbing/reactivity) and describe the frequency and type of the clinical and rehabilitative needs of the Veterans and the type and duration of divergences (e.g. rehabilitative techniques) made by providers.

Trial details

Enrollment: 194 participants (actual)
Started: Mar 15, 2021
Study completion: Aug 1, 2025
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, single blind, treatment
Oversight: Data monitoring committee
Conditions: Stress Disorders, Post-Traumatic, Posttraumatic Stress Disorder
Official title: Personalizing Cognitive Processing Therapy With a Case Formulation Approach to Intentionally Target Impairment in Psychosocial Functioning Associated With PTSD
First posted: May 29, 2020
Registry updated: Oct 29, 2026
Last verified: Oct 2026

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