Problem-Solving Training for Concussion

NCT05837676 | Recruiting

• 2 other identifiers: D4778-RRX004778-01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Concussion

Keywords

Mild Traumatic Brain Injury; Concussion, Mild; Veterans; Neurobehavioral Manifestations; Psychological Distress

Outcome Measures

Primary Outcomes (1)

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

  The BSI-18 is a brief measure of psychological distress brought about by common somatic and affective symptoms. It has been validated for use in patients with history of TBI and is appropriate for use in primary care. Similar to a previous trial of PST for mTBI, its Global Severity Index (GSI) T-score will serve as the primary outcome measure. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.

  Up to 24 weeks

Secondary Outcomes (5)

• Hopkins Verbal Learning Test-Revised (HVLT-R)

  Up to 24 weeks

• Neurobehavioral Symptom Inventory (NSI)

  Up to 24 weeks

• Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span

  Up to 24 weeks

• World Health Organization Quality of Life - BREF (WHOQOL-BREF)

  Up to 24 weeks

• Inventory of Psychosocial Functioning (IPF)

  Up to 24 weeks

Other Outcomes (10)

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

  Up to 24 weeks

• Patient Health Questionnaire-9 (PHQ-9)

  Up to 24 weeks

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

  Up to 24 weeks

Study Arms (2)

PST-Concussion

EXPERIMENTAL

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.

Behavioral: Problem Solving Training for Concussion

Treatment as usual (TAU)

OTHER

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.

Other: Treatment as usual

Interventions

Problem Solving Training for Concussion BEHAVIORAL

PST-Concussion is a combined treatment consisting of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies.

Also known as: PST-Concussion

PST-Concussion

Treatment as usual OTHER

Patients assigned to TAU will receive the care that they and their providers determine is necessary to best manage their presenting concerns.

Also known as: TAU

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Neurobehavioral Manifestations

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul R. King, PhD

  VA Western New York Healthcare System, Buffalo, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul R King, PhD

CONTACT

(716) 862-6038; paul.king2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors will conduct outcome assessments at 12-week post-test and 24-week follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 to either PST-Concussion or treatment as usual (TAU).

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Requests will be considered beginning 6 months after final publication.
• Access Criteria: Limited datasets in machine-readable electronic format will be created and shared pursuant to a Data Use Agreement (DUA). Appropriate use of the electronic dataset will be specified, as will prohibitions against identifying or re-identifying (i.e., taking steps to identify or re-identify) any individual whose data are included in the dataset.

Locations

US (1)