Problem-Solving Training for Concussion

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This study will be a longitudinal randomized two-arm parallel group clinical trial. Participants will be randomized 1:1 to either PST-Concussion or treatment as usual (TAU). Participants assigned to PST-Concussion will receive six, approximately 30-minute telehealth treatment sessions. Assessments will include standard self-report and cognitive measures that will be administered at baseline, post-treatment, and three-month follow-up. The primary objective of this study will be to evaluate the effectiveness of PST-Concussion in reducing psychological distress compared to TAU. Secondary and tertiary objectives will be to evaluate whether PST-Concussion is associated with appreciable change in subjective neurocognitive functioning, objective neurocognitive functioning, psychosocial functioning, and disability and quality of life. Multi-level modeling will be used to evaluate treatment effects at post-treatment and three-month follow-up. A test of non-inferiority will be conducted to evaluate the potential durability of observed treatment effects from post-test to follow-up. A portion of participants assigned to PST-Concussion will also be interviewed at post-treatment or follow-up to gain insight into the practical impact of intervention on psychosocial functioning and quality of life. ;

Study Design

Related Conditions & MeSH terms

Brain Concussion

Clinical Trial Details

NCT number	NCT05837676
Study type	Interventional
Source	VA Office of Research and Development
Contact	Paul R King, PhD
Phone	(716) 862-6038
Email	paul.king2@va.gov
Status	Recruiting
Phase	N/A
Start date	November 1, 2023
Completion date	September 30, 2027

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT00409058` - Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI	N/A
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Completed	`NCT03319966` - Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
Completed	`NCT04681742` - Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome	N/A
Completed	`NCT03759223` - Enhanced Problem-Solving Training	N/A
Completed	`NCT00857207` - Metacognitive Training to Enhance Strategy Use in Blast-Related TBI	N/A
Not yet recruiting	`NCT06131242` - The s100β Levels in Patients With Mild Brain Injury.
Completed	`NCT02368366` - Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI	N/A
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Recruiting	`NCT00724607` - Brain Injury Outcomes (BIO) Study
Unknown status	`NCT02699359` - Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion	N/A
Completed	`NCT02486003` - Testing mTBI in Athletes	N/A
Completed	`NCT02455037` - Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Problem-Solving Training for Concussion — PST-Concussion

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms