Clinical trial NCT05837676: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Concussion
Keywords: Mild Traumatic Brain Injury
Concussion, Mild
Veterans
Neurobehavioral Manifestations
Psychological Distress
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-05-01
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to either PST-Concussion or treatment as usual (TAU).
Primary purpose: TREATMENT

Brief 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: 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.

Primary outcomes:
measure: Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: Up to 24 weeks
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: Up to 24 weeks
measure: Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
timeFrame: Up to 24 weeks
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: Up to 24 weeks
measure: Inventory of Psychosocial Functioning (IPF)
timeFrame: Up to 24 weeks
Other outcomes:
measure: Applied Cognition-General Concerns-Short Form (ACGC-8a)
timeFrame: Up to 24 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Up to 24 weeks
measure: Applied Cognition-Abilities-Short Form (ACA-8a)
timeFrame: Up to 24 weeks
measure: PTSD Checklist for DSM-5 (PCL5)
timeFrame: Up to 24 weeks
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Up to 24 weeks
measure: Pain Symptom Survey (PEG)
timeFrame: Up to 24 weeks
measure: Patient Global Impressions of Change (PGIC)
timeFrame: Up to 24 weeks
measure: Community Reintegration of Service-Members (CRIS)
timeFrame: Up to 24 weeks
measure: Drug Abuse Screening Test (DAST10)
timeFrame: Up to 24 weeks
measure: Behavioral Health Measure-20 (BHM-20)
timeFrame: Up to 12 weeks
Locations:
city: Buffalo
country: United States
facility: VA Western New York Healthcare System, Buffalo, NY
state: New York
Study officials:
affiliation: VA Western New York Healthcare System, Buffalo, NY
name: Paul R. King, PhD
role: PRINCIPAL_INVESTIGATOR
References: