Problem-Solving Training for Concussion (PST-Concussion)

VA Office of Research and Development

Status: Enrolling

Conditions: Brain Concussion

Treatments: Other: Treatment as usual; Behavioral: Problem Solving Training for Concussion

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05837676

D4778-R

RX004778-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

PST-Concussion

Experimental group

Description:

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.

Treatment:

Behavioral: Problem Solving Training for Concussion

Treatment as usual (TAU)

Other group

Description:

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.

Treatment:

Other: Treatment as usual