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NCT05837676NARecruiting

Problem-Solving Training for Concussion

VA Office of Research and Development

Start Date

10/1/2023

Completion Date

9/30/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * English-speaking Veteran enrolled in VHA care; * History of concussion (mild traumatic brain injury or mTBI); * Current psychological distress; * Subjective neurocognitive symptoms of \>= 3 months. Exclusion Criteria: * Moderate to severe TBI or other major neurocognitive disorder; * Psychotic disorder (e.g., schizophrenia spectrum disorder, delusional disorder, bipolar or depressive disorder with psychotic features); * Acute suicidal ideation; * Inpatient psychiatric hospitalization within the past 12 months; * Other illness/ condition that would preclude or predictably influence ability to engage in study visits, as determined by the study team.

Interventions

BEHAVIORAL

Problem Solving Training for Concussion

OTHER

Treatment as usual

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Conditions

Brain Concussion

Locations

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York 14215-1129

United States