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NCT04407767 · ClinicalTrials.gov registry record · NA

A Case Formulation Approach to Cognitive Processing Therapy

A NA study of Posttraumatic Stress Disorder, sponsored by VA Office of Research and Development.

Active
Registry status
NA
Development phase
179
Enrollment target
8
Study locations

NCT04407767 is a NA study of Posttraumatic Stress Disorder that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 179 participants, above the 110-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (63% higher). The trial reports 8 study locations across 8 states.

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The verdict

NCT04407767, a NA study of Posttraumatic Stress Disorder, is active but no longer recruiting, sponsored by VA Office of Research and Development.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
179 participants
Enrollment target
8
Study locations

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

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

FieldValue
Enrollment Target 179 participants
Start Date 2021-03-15
Est. Completion 2026-09-01
Phase NA

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT04407767

The ClinicalTrials.gov registry entry for NCT04407767 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 110-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (63% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

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.

NCT04407767 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Arizona, Hawaii, Louisiana.

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.

What interventions are being tested in trial NCT04407767?

The interventions under investigation include: Cognitive Processing Therapy (BEHAVIORAL), Case Formulation plus Cognitive Processing Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT04407767?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

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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