A Case Formulation Approach to Cognitive Processing Therapy

NCT04407767 | Completed DMC

• 1 other identifier: F3369-R
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Cognitive Processing Therapy; Case Formulation; Functional Outcomes; Psychosocial Functioning

Outcome Measures

Primary Outcomes (2)

• Inventory of Psychosocial Functioning (assessing change over time)

  This standardized self-report instrument assesses PTSD-related psychosocial functioning. The IPF is an 80-item self-report questionnaire of functional impairment across several domains including relationships, work, parenting, education, and general daily functioning over the past 30 days. Domain scores can range from 0 to 100 with higher values corresponding to higher functioning. Overall functioning score was calculated as the mean of all completed IPF domain scores. As participants may skip certain domains that do not apply to them (thus leading to different sample sizes for analyses predicting different domains of functioning), overall score was calculated as total sum of all completed IPF domain scores divided by the actual number of domains completed by the participant.

  Assesses functioning over the 30 days prior to baseline assessment, change between baseline and session 6, change over following treatment (post-treatment), and at the 3-month follow-up interval.

• Clinician-Administered PTSD Scale-5 (CAPS) (assessing change over time)

  The CAPS is a 30-item structured interview that corresponds to the DSM-5 criteria for PTSD. The CAPS will be used to make a current (past month) and lifetime diagnosis of PTSD. In addition to assessing the 20 PTSD symptoms, questions target the impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and frequency and intensity of five associated symptoms. For each item, standardized questions and probes are provided. CAPS-5 diagnosis demonstrated strong interrater reliability, and test-retest reliability, as well as strong correspondence with a diagnosis based on the CAPS for DSM-IV. CAPS-5 total severity score demonstrated high internal consistency, and interrater reliability, and good test-retest reliability, and good discriminant validity with measures of anxiety, depression, somatization, functional impairment, psychopathy, and alcohol abuse.

  Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.

Secondary Outcomes (21)

• WHO - Disability Assessment Schedule 2.0 (WHODAS-II) (assessing change over time)

  Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.

• WHO - Quality of Life - Brief (assessing change over time)

  Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.

• Well-Being Inventory (WBI) (assessing change over time)

  Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.

• PTSD Checklist-DSM-5 (PCL-5) (assessing change over time)

  Administered at baseline, weekly (during treatment) mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.

• Patient Health Questionnaire - 9 (assessing change over time)

  Administered at baseline, weekly (during treatment), mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.

Study Arms (2)

Case Formulation plus Cognitive Processing Therapy

EXPERIMENTAL

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.

Behavioral: Case Formulation plus Cognitive Processing Therapy

Cognitive Processing Therapy

ACTIVE 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: Cognitive Processing Therapy

Interventions

Cognitive Processing Therapy BEHAVIORAL

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.

Cognitive Processing Therapy

Case Formulation plus Cognitive Processing Therapy BEHAVIORAL

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.

Case Formulation plus Cognitive Processing Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans with posttraumatic stress disorder (PTSD)

You may not qualify if:

• Patients should not be participating in another trauma-focused therapy at the time of enrollment but can continue any psychiatric medications (dose must be stable for one month prior to enrollment)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (8)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

Location

VA Pacific Islands Health Care System, Honolulu, HI

Honolulu, Hawaii, 96819-1522, United States

Location

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, 70119, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106-1621, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

Salem VA Medical Center, Salem, VA

Salem, Virginia, 24153-6404, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Tara Ellen Galovski, PhD MA BS

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

• Shannon M. Kehle-Forbes, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will be blind to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This randomized controlled clinical trial seeks to examine the relative efficacy of a case formulation approach integrated into cognitive processing therapy as compared to standard cognitive processing therapy. Randomization to study condition will occur at the provider level (50 providers will be randomized to either CPT or CF-CPT. Each provider will treat the next 4 eligible veterans (total sample = 200 Veterans) seeking care for PTSD who agree to participate in the study.

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 29, 2020
• Study Start: March 15, 2021
• Primary Completion: July 22, 2025
• Study Completion: August 1, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)