Problem-Solving Training for Concussion

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

• Hopkins Verbal Learning Test-Revised (HVLT-R) [Срок оценки: Up to 24 weeks]
• Neurobehavioral Symptom Inventory (NSI) [Срок оценки: Up to 24 weeks]
• Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span [Срок оценки: Up to 24 weeks]
• World Health Organization Quality of Life - BREF (WHOQOL-BREF) [Срок оценки: Up to 24 weeks]
• Inventory of Psychosocial Functioning (IPF) [Срок оценки: Up to 24 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VA Western New York Healthcare System, Buffalo, NY — Buffalo

Идентификаторы

NCT: NCT05837676 · D4778-R · RX004778-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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