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Problem-Solving Training for Concussion (PST-Concussion Trial)
N/A
Recruiting
Led By Paul R. King, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
PST-Concussion Trial Summary
This trial tests an intervention to help veterans with mTBI recover from long-lasting neurobehavioral symptoms and impairment.
Who is the study for?
This trial is for English-speaking Veterans enrolled in VHA care who have had a concussion and are experiencing ongoing psychological distress and cognitive symptoms for three months or more. It's not suitable for those with moderate to severe brain injuries, major neurocognitive disorders, psychotic disorders, recent suicidal thoughts, or recent psychiatric hospitalization.Check my eligibility
What is being tested?
The study evaluates Problem-Solving Training (PST-Concussion), designed to help Veterans recover from mild traumatic brain injury by improving their coping skills. This treatment will be compared with the usual care provided to see if it can better address the complex issues faced after a concussion.See study design
What are the potential side effects?
Since PST-Concussion is a behavioral health intervention focusing on problem-solving skills rather than medication, side effects are minimal but may include temporary increases in distress as patients confront challenging issues during therapy.
PST-Concussion Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
Secondary outcome measures
Hopkins Verbal Learning Test-Revised (HVLT-R)
Inventory of Psychosocial Functioning (IPF)
Neurobehavioral Symptom Inventory (NSI)
+2 moreOther outcome measures
Alcohol Use Disorders Identification Test (AUDIT)
Applied Cognition-Abilities-Short Form (ACA-8a)
Applied Cognition-General Concerns-Short Form (ACGC-8a)
+7 morePST-Concussion Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment as usual (TAU)Experimental Treatment1 Intervention
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.
Group II: PST-ConcussionExperimental Treatment1 Intervention
Treatment 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,150 Total Patients Enrolled
Paul R. King, PhDPrincipal InvestigatorVA Western New York Healthcare System, Buffalo, NY
1 Previous Clinical Trials
50 Total Patients Enrolled
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Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical research project accepting volunteers at the present time?
"The study, posted on October 1st 2023 and last revised April 19th 2023, is no longer seeking new patients. However, there are 80 other clinical trials actively recruiting participants at this present moment."
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