Problem-Solving Training for Concussion (PST-Concussion)

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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

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

Trial contacts and locations

0

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Central trial contact

Paul R King, PhD

Data sourced from clinicaltrials.gov

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