What side effects are associated with this type of intervention?

Behavioral interventions for concussion, such as Problem-Solving Training, generally have minimal side effects compared to pharmacological treatments. Common side effects may include temporary increases in anxiety or stress as patients confront and work through their cognitive challenges. Additionally, some individuals might experience frustration or fatigue from the mental effort required during therapy sessions. However, these side effects are typically mild and transient, making behavioral interventions a relatively safe option for managing concussion symptoms.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of concussion itself. The management of concussion typically involves a multidisciplinary approach, including cognitive and physical rest, and in some cases, behavioral interventions such as cognitive-behavioral therapy (CBT) and problem-solving training. These interventions aim to address cognitive and functional recovery by teaching problem-solving skills and managing symptoms. While pharmacologic treatments may be used to address specific symptoms like sleep disturbances or dizziness, the primary focus remains on non-pharmacologic, supportive care.

What other types of research exist?

Promising alternatives to PST-Concussion for treating concussion patients include: 1) Cognitive Behavioral Therapy (CBT), which has been shown to be effective in managing persistent symptoms of ADHD and could be adapted for concussion-related cognitive issues. 2) Online Family Problem-Solving Treatment (OFPST), which has demonstrated efficacy in improving behavioral outcomes in pediatric TBI and could be adapted for adults. 3) Web-based Counselor-Assisted Problem Solving (CAPS), which has been effective in treating executive dysfunction in adolescents post-TBI and could be beneficial for adults. These interventions leverage structured, skills-based approaches to address cognitive and functional impairments.

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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

Summary

This trial is testing a new treatment called PST-Concussion to help Veterans with mild traumatic brain injury manage their symptoms. The study aims to see if this treatment can reduce psychological distress and improve overall functioning. If successful, it could offer a practical way to support Veterans' recovery. Problem-solving treatment (PST) has been previously explored as a method to help service members with mild traumatic brain injury manage their symptoms.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score

Secondary study objectives

Hopkins Verbal Learning Test-Revised (HVLT-R)

Inventory of Psychosocial Functioning (IPF)

Neurobehavioral Symptom Inventory (NSI)

+2 more

Other study objectives

Alcohol Use Disorders Identification Test (AUDIT)

Applied Cognition-Abilities-Short Form (ACA-8a)

Applied Cognition-General Concerns-Short Form (ACGC-8a)

+7 more

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Problem-Solving Training for Concussion (PST-Concussion) is a behavioral intervention designed to improve cognitive and functional recovery in concussion patients by teaching them structured problem-solving skills. The mechanism of action involves enhancing the patient's ability to identify problems, generate and evaluate potential solutions, and implement effective strategies. This approach helps mitigate the neurobehavioral complaints and functional impairments often associated with concussions. By improving cognitive processes and daily functioning, PST-Concussion can significantly enhance the quality of life and overall recovery experience for concussion patients.

Telephone Problem Solving for Service Members with Mild Traumatic Brain Injury: A Randomized, Clinical Trial.A systematic review of psychological treatments for mild traumatic brain injury: an update on the evidence.Cognitive rehabilitation: the role of theoretical rationales and respect for the maturational process needed for our evidence.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,647 Previous Clinical Trials

3,359,936 Total Patients Enrolled

Paul R. King, PhDPrincipal InvestigatorVA Western New York Healthcare System, Buffalo, NY

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Problem Solving Training for Concussion 2023 Treatment Timeline for Medical Study. Trial Name: NCT05837676 — N/A

~89 spots leftby Mar 2027

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