Graded Exposure Therapy for Fear Avoidance Behaviour (GET FAB) After Concussion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
- 试验地点
- 7
- 主要终点
- Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change
研究概览
简要总结
Concussions are very common. Although many people recover well from concussion, some will have persistent symptoms and difficulties with daily activities. How people cope with their symptoms following concussion powerfully influences their recovery. Fear avoidance behaviour is a particularly unhelpful approach to coping, in which people perceive their pre-injury activities as unnecessarily dangerous and take great care to avoid overexertion and overstimulation. The investigators developed and pilot tested a behavioural therapy, called graded exposure therapy, to reduce fear avoidance behaviour. Our preliminary work suggested that graded exposure therapy was acceptable to patients with concussion and possibly beneficial for their recovery. The GET FAB after concussion study will assess the effectiveness of graded exposure therapy.
详细描述
GET FAB is a multisite randomized controlled trial designed to evaluate a behavioural treatment (graded exposure therapy) for adults with persistent symptoms after concussion. Participants in this study will be recruited from a network of concussion clinics in Canada. This study follows from the investigators' prior work establishing that (1) fear avoidance behaviour is a risk factor for poor concussion outcome, (2) graded exposure therapy reduces fear avoidance behaviour, and (3) graded exposure therapy is perceived as credible and is well-tolerated by patients with persistent post-concussion symptoms.
Participants will be assigned at random (in a 1:2:2 ratio) to receive enhanced usual care, graded exposure therapy group, or another therapy that might have similar benefits (prescribed aerobic exercise). The investigators hypothesize that patients who participate in graded exposure therapy will have reduced fear avoidance behaviour and improved daily functioning compared to other treatment conditions and this difference will be greatest for patients who enter the study with high fear avoidance behaviour.
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)
盲法说明
Participants will be blinded to the study hypotheses and treatment arms, but not to the type of intervention they are receiving. Outcome assessors will be blinded to participants' treatment assignments.
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
- 否
入选标准
- •aged 18-70 years;
- •sustained a concussion according to the ACRM mTBI Task Force definition between 1 and 24 months ago
- •fluent in English, because validated translations are not available for most questionnaires and recruiting multilingual therapists is not feasible;
- •access to a computer, tablet, or smartphone with internet capability;
- •3 or more moderate-severe symptoms on the Rivermead Postconcussion Symptom Questionnaire.
排除标准
- •medical contraindication to aerobic exercise (cardiac disease, chest pain with exertion, acute bone/joint/soft tissue injury aggravated by exercise)
- •change in cardiac medication within the last month, such as beta blockers, calcium channel blockers, or ivabradine
- •involved in personal injury litigation for index mTBI
- •currently pregnant or plan to become pregnant within the next three months
- •severe/unstable medical or psychiatric condition that could worsen over the next year")
研究组 & 干预措施
Arm 1: Graded Exposure Therapy
干预措施: Graded Exposure Therapy (Behavioral)
Arm 2: Prescribed Aerobic Exercise
干预措施: Prescribed aerobic exercise (Behavioral)
Arm 3: Enhanced usual care
干预措施: Enhanced usual care (Other)
结局指标
主要结局
Rivermead Post Concussion Symptoms Questionnaire (RPQ): Change
时间窗: 3 months
Score of 0-64, with a higher score indicates worse symptoms.
次要结局
- Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI): Change(3 months)
研究者
Noah Silverberg
Principal Investigator
University of British Columbia