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NCT04407767 · ClinicalTrials.gov registry record · NA
A Case Formulation Approach to Cognitive Processing Therapy
A NA study of Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development.
- Active
- Registry status
- NA
- Development phase
- 179
- Enrollment target
- 8
- Study locations
NCT04407767: Active NA study of Post Traumatic Stress Disorder, sponsored by VA Office of Research and Development.
NCT04407767 is a NA study of Post Traumatic Stress Disorder that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 179 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (73% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04407767, a NA study of Post Traumatic 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
Primary Outcome
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 c
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 |
What the registry record for NCT04407767 still lists
NCT04407767 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Processing Therapy is the first listed.
NCT04407767 lists 8 locations in 8 states (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: Post Traumatic 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04407767's enrollment target sits among peer trials
179 66th of 262 higher than 197 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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