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A Case Formulation Approach to Cognitive Processing Therapy
NCT04407767 · View on ClinicalTrials.gov ↗
Study 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 sym
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Processing Therapy
- BEHAVIORAL Case Formulation plus Cognitive Processing Therapy
Study Locations (8)
Arizona
- Phoenix VA Health Care System, Phoenix, AZ — Phoenix
Hawaii
- VA Pacific Islands Health Care System, Honolulu, HI — Honolulu
Louisiana
- Southeast Louisiana Veterans Health Care System, New Orleans, LA — New Orleans
Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston
Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis
Missouri
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston
Virginia
- Salem VA Medical Center, Salem, VA — Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2026-09-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04407767
The ClinicalTrials.gov registry entry for NCT04407767 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions — of which Cognitive Processing Therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04407767 reports 8 study locations spanning 8 distinct geographic areas — top geographies include Arizona, Hawaii, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04407767 about?
NCT04407767 is a clinical study titled "A Case Formulation Approach to Cognitive Processing Therapy". 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 ra...
What is the current status of trial NCT04407767?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 179 participants. The study started on 2021-03-15. Estimated completion is 2026-09-01.
What conditions does trial NCT04407767 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04407767?
The interventions under investigation include: Cognitive Processing Therapy (BEHAVIORAL), Case Formulation plus Cognitive Processing Therapy (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04407767?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04407767 being conducted?
This trial has 8 study locations across Arizona, Hawaii, Louisiana, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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