Recruiting

Problem-Solving Training

Sponsor:

VA Office of Research and Development

Code:

NCT05837676

Conditions

Brain Concussion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Problem Solving Training for Concussion

Treatment as usual

Study Details

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

Study ID

NCT05837676

Start date

Oct 1, 2023

Status verified date

Sep, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PST-Concussion

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.

other: Treatment as usual (TAU)

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.

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Paul R King, PhD

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

Locations

VA Western New York Healthcare System, Buffalo, NY

Recruiting

Buffalo, New York, United States, 14215-1129

Contacts

Paul R King, PhD

716-862-6038paul.king2@va.gov

Principal Investigator:

Paul R. King, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 8, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-09-08.