Problem-Solving Training for Concussion
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05837676
- Status
- Recruiting
Conditions
- Brain Concussion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Problem Solving Training for Concussion — BEHAVIORALPST-Concussion is a combined treatment consisting of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies.
- Treatment as usual — OTHERPatients assigned to TAU will receive the care that they and their providers determine is necessary to best manage their presenting concerns.
Study Details
Mild traumatic brain injury (mTBI), also known as concussion, is a common injury sustained by Veterans. While most individuals who sustain mTBI experience a complete recovery within several weeks of injury, many Veterans with history of mTBI report frequent and long-lasting neurobehavioral complaints and functional impairment. Though research suggests that these outcomes are strongly influenced by co-occurring conditions such as post-traumatic stress disorder, depression, and chronic pain, evidence-based interventions capable of addressing this wide array of concerns are lacking. This study seeks to address this gap by evaluating the effectiveness of a brief and flexible behavioral health treatment (Problem-Solving Training for Concussion, or PST-Concussion), which was designed to be delivered by generalist providers working in VA primary care settings. If PST-Concussion is shown to be effective, this skills-focused intervention may help improve Veterans' recovery experience following mTBI.
Key Dates
- Start date
- Oct 1, 2023
- Status verified
- Sep 2025
- Primary completion
- Mar 31, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 134 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: PST-ConcussionTreatment arm. Six, approximately 30-minute telehealth treatment sessions comprised of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies.
- Other: Treatment as usual (TAU)Control arm. Primary care treatment as usual. Patients assigned to TAU will receive the care that they and their providers determine is necessary to best manage their presenting concerns.
Primary Outcome Measure
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score [ Time Frame: Up to 24 weeks ]
Central Contacts
- Paul R King, PhD(716) 862-6038
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | 14215-1129 | Paul R. King, PhD (PRINCIPAL_INVESTIGATOR) |
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