Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item
研究概览
简要总结
At least 1 in 5 people who sustain a concussion will have persistent symptoms and difficulties with daily activities. The researchers have identified two unhelpful coping styles following a concussion - avoidance and endurance. Individuals who engage in avoidance behavior may benefit from a different type of treatment than those who engage in endurance behavior. The researchers will evaluate whether assigning individuals to a specific psychologically-informed treatment tailored to their coping style is practical, acceptable, and beneficial for their recovery.
详细描述
Psychosocial factors are known to affect recovery from concussion, but are not sufficiently taken into account by current treatment approaches. Distinct behavioral profiles after concussion have emerged in our research: (1) avoidance, where individuals perceive activity as overly dangerous and take care to avoid overexertion, and (2) endurance, where individuals persist with high levels of activity despite worse symptoms until they "crash," requiring recuperative rest. The researchers hypothesize that patients with these behavioral profiles likely benefit from different treatment approaches. The next step in our research program is to evaluate the feasibility and potential impact of tailoring therapies based on an Avoidance-Endurance Model adapted from the chronic pain literature.
The proposed project aims to evaluate whether matching patients with concussion to tailored therapies based on their behavioral profile (avoidance vs endurance) is feasible. A secondary aim is to test our hypothesis that participants receiving the intervention matched to their behavioral profile will have less post-treatment disability than mismatched participants.
In a pilot double-blind (patient, assessor) RCT with 1:1 allocation stratified by behavioral profile (avoidance vs. endurance), 64 adults with persistent symptoms after concussion will complete an initial evaluation, an activity diary over the following week, and then be randomized to receive an interdisciplinary treatment package tailored to avoidance or endurance profiles.
In brief, the program designed for avoidance will involve graded exposure to cognitively demanding activity (e.g., mental math exercises), physical exertion (e.g., treadmill jogging), and sensory stimulation (e.g., scenes with visual motion). The focus of the endurance program will be pacing, i.e., shifting from symptom-contingent to time-contingent behavior. A blinded assessor will administer outcome measures 12 weeks after enrollment. Feasibility criteria include acceptability of randomization and treatment tolerability, fidelity, and adherence.
Proposed changes to "profile matching" study due to COVID-19 pandemic (March 30, 2020)
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-70 years old.
- •Sustained a mild traumatic brain injury between 1 and 12 months ago.
- •Fluent in English.
- •Access to a computer, tablet, or smartphone with internet capability.
- •3+ persistent moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire.
- •High avoidance (Fear Avoidance Behavior after Traumatic Brain Injury; FAB-TBI) and/or endurance behavior (Behavioral Response to Illness Questionnaire - All-Nothing subscale).
排除标准
- •Patients with a cardiac contraindication to aerobic exercise will be excluded
研究组 & 干预措施
Graded exposure therapy
Weekly 60-min sessions with an occupational therapist and psychologist over 8 weeks.
干预措施: Graded exposure therapy (Behavioral)
Pacing + mindfulness
Weekly 60-min sessions with an occupational therapist and psychologist over 8 weeks.
干预措施: Pacing + mindfulness (Behavioral)
结局指标
主要结局
World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12-item
时间窗: Initial assessment, past 30 days.
次要结局
- Rivermead Postconcussion Symptom Questionnaire(initial assessment, past 24 hours.)
研究者
Noah Silverberg
Principal Investigator
University of British Columbia