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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded assessors will conduct outcome assessments at 12-week post-test and 24-week follow-up.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
时间窗: Up to 24 weeks
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.
次要结局
- Hopkins Verbal Learning Test-Revised (HVLT-R)(Up to 24 weeks)
- Neurobehavioral Symptom Inventory (NSI)(Up to 24 weeks)
- Inventory of Psychosocial Functioning (IPF)(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)