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Clinical Trials/NCT05165940
NCT05165940
Not yet recruiting
Not Applicable

Improving Care for Veterans by Understanding and Facilitating Transition to Recommended PTSD Treatment (CDA 21-194)

VA Office of Research and Development1 site in 1 country40 target enrollmentFebruary 1, 2026
ConditionsPTSD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
VA Office of Research and Development
Enrollment
40
Locations
1
Primary Endpoint
Initiation of Recommended PTSD Treatment
Status
Not yet recruiting
Last Updated
4 months ago

Overview

Brief Summary

Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9/11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Little research has explored the combinations and sequences of psychosocial and medication treatments that Veterans receive ("treatment sequences"). One common and understudied treatment sequence begins with stabilization treatment, which is designed to prepare Veterans for CPT or PE. There is a significant research gap in understanding how treatment sequence affects initiation of CPT or PE. The proposed research is an innovative, mixed-methods approach to assessing the impact of variability in treatment sequence, including stabilization treatment, on initiation of CPT or PE and applying this knowledge by developing a health services intervention that facilitates timely transition to CPT or PE. Research aims can improve PTSD treatment by increasing initiation of and reducing disparities in CPT/PE.

Detailed Description

Posttraumatic stress disorder (PTSD) is one of the most common mental health diagnoses among Veterans. Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated in the Veterans Health Administration (VHA) as recommended PTSD treatments. Despite these efforts, few post-9/11 Veterans diagnosed with PTSD initiate CPT or PE. In the small percentage of Veterans who receive these therapies, CPT and PE are rarely the first treatment a Veteran receives. A common treatment sequence identified in implementation research, begins with "stabilization treatment," combinations of psychosocial and medication treatments that prepare Veterans for CPT or PE. Despite consistently identifying stabilization treatment as a common VHA practice, little research has investigated this treatment sequence. A novel approach to solving existing limitations in PTSD treatment delivery involves developing an intervention that both acknowledges the ubiquitous presence and benefits of stabilization treatment, while facilitating timely transition from stabilization treatment to CPT or PE. This CDA-2 aims to improve delivery of PTSD services in the VHA. The proposed research aims are: (1) To qualitatively understand Veterans' and clinicians' perspectives on selecting stabilization treatments and how stabilization treatment serves as a barrier or facilitator of transition to CPT or PE; (2) To develop and conduct a randomized, pragmatic pilot trial of a brief, Veteran-centered intervention to support transition from stabilization treatment to CPT or PE; and (3) To identify sociodemographic disparities in treatment sequences and to determine how treatment sequences influence time to CPT or PE initiation across the VHA.

Registry
clinicaltrials.gov
Start Date
February 1, 2026
End Date
May 3, 2027
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with PTSD as part of an intake assessment at the San Francisco Veterans Affairs Medical Center.

Exclusion Criteria

  • Inability to provide informed consent
  • Cognitive impairment that precludes comprehension of study materials
  • Active psychosis

Outcomes

Primary Outcomes

Initiation of Recommended PTSD Treatment

Time Frame: Through study completion, an average of 1 year

Patient self-report or documentation in the electronic health record of initiating either cognitive processing therapy (CPT) or prolonged exposure therapy (PE).

Secondary Outcomes

  • Limited Efficacy Testing (PTSD Symptom Severity)(Through study completion, an average of 1 year)
  • Acceptability (Discontinuation of Mental Health Treatment without Provider Concurrence)(Through study completion, an average of 1 year)

Study Sites (1)

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