Problem-Solving Training for Concussion

Official title

Problem-Solving Training for Concussion (PST-Concussion): A Brief, Skills-Focused Intervention to Improve Functional Outcomes in Veterans With mTBI and Co-occurring Mental Health Symptoms

Overview

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.

Interventions

• Behavioral Problem Solving Training for Concussion
  PST-Concussion is a combined treatment consisting of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies.
• Other 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 measures

• Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score [Time frame: Up to 24 weeks]

Secondary outcome measures (5)

• Hopkins Verbal Learning Test-Revised (HVLT-R) [Time frame: Up to 24 weeks]
• Neurobehavioral Symptom Inventory (NSI) [Time frame: Up to 24 weeks]
• Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span [Time frame: Up to 24 weeks]
• World Health Organization Quality of Life - BREF (WHOQOL-BREF) [Time frame: Up to 24 weeks]
• Inventory of Psychosocial Functioning (IPF) [Time frame: Up to 24 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• VA Western New York Healthcare System, Buffalo, NY — Buffalo

Identifiers

NCT: NCT05837676 · D4778-R · RX004778-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗