SMART-CPT for PTSD/Concussion Implementation
Part of paid clinical trials in San Diego, California.
- Sponsor
- San Diego Veterans Healthcare System
- Study ID
- NCT06995612
- Status
- Enrolling By Invitation
Conditions
- Concussion, Mild
- PTSD
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- SMART-CPT — BEHAVIORALSMART-CPT T is a psychotherapy that combines Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) and Cognitive Symptom Management and Rehabilitation Training (CogSMART) for neurobehavioral and neurocognitive symptoms to simultaneously target persistent postconcussive symptoms and PTSD
- CPT — BEHAVIORALCPT is a cognitive behavioral treatment specifically targeting PTSD and other corollary symptoms following traumatic events (Resick \& Schnicke, 1992). Based on a social cognitive theory of PTSD and trauma, CPT focuses on identifying the content of trauma-related thoughts, examining whether these thoughts are consistent or inconsistent with a patient's prior beliefs about the world, and addressing the impact these thoughts have on emotions and behaviors. Patients are taught to recognize and challenge thought patterns such as, assimilation (distorting the memory of the traumatic event to fit prior world beliefs), over-accommodation (excessively altering world beliefs to be consistent with the trauma), or the reinforcement of previously held distorted world beliefs.
Study Details
The clinical implementation trial will evaluate effectiveness and feasibility, acceptability, appropriateness, barriers, and facilitators of implementing SMART-CPT, a treatment targeting the two primary factors leading to poor outcomes following concussion, in Veterans. It will test effectiveness and broad implementation feasibility of SMART-CPT compared to standard Cognitive Processing Therapy (CPT).
Key Dates
- Start date
- Dec 1, 2024
- Status verified
- Mar 2025
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 124 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SMART-CPT
- Active Comparator: CPT
Primary Outcome Measure
PTSD Checklist (PCL5) [ Time Frame: weekly through treatment completion, an average of 3 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA San Diego | San Diego | California | 92161 | - |
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