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临床试验/NCT00893347
NCT00893347已完成2 期

Prevention of Persistent Post-concussion Syndrome With Cognitive-behavioural Therapy in At-risk Patients

University of British Columbia1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2009年6月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
28
试验地点
1
主要终点
PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)

研究概览

简要总结

This study investigates how well a new therapy program prevents persistent symptoms (e.g., headaches, fatigue, irritability, etc.) after concussion. The program involves examining beliefs about concussion and learning healthy coping strategies, and is completed with the first three months post-injury.

详细描述

Although the majority of patients with mild traumatic brain injury (MTBI) experience complete recovery within three months, a sizeable group continues to report frequent and severe symptoms such as headaches, fatigue, difficulty concentrating, forgetfulness, and irritability, in what is labeled persistent post-concussion syndrome (PCS). Persistent PCS is associated with vocational, recreational, and social disability. Early education and reassurance (treatment as usual) is effective in general, but appears insufficient for this subgroup.

Recent research has identified risk factors for persistent PCS, including inaccurate illness beliefs, maladaptive coping behaviour, and emotional distress. The present study will evaluate the additive efficacy of a cognitive-behavioural therapy protocol designed to modify these risk factors, over and above treatment as usual.

Participants with MTBI will be recruited within six weeks of injury. Those identified as being at-risk for persistent PCS based on evidence-based criteria will receive treatment as usual and then be randomly assigned to receive either no further intervention or cognitive-behavioural therapy. We hypothesize that the group receiving cognitive-behavioural therapy will have fewer PCS symptoms and be less disabled at follow-up. We also hypothesize that compensation-seeking status will mitigate this improvement and that illness beliefs, coping behaviour, and emotional distress will mediate this improvement. A blinded rater will conduct the baseline and outcome assessments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Incurred head trauma within six weeks of study entry
  • Meet American Congress of Rehabilitation criteria for MTBI, documented by the referring/treating physician
  • Subjective report at least one symptom attributable to head trauma
  • English as preferred language for communication
  • Considered at-risk for persistent PCS based on prognostic model from Whittaker et al. (2007)

排除标准

  • Medical documentation of skull fracture or acute intracranial abnormality on neuroimaging, consistent with "mild-complicated" TBI
  • Self-reported history of a neurological disorder (including prior MTBI within the past six months)

研究组 & 干预措施

II

Experimental

Treatment as usual + cognitive-behavioural therapy

干预措施: Cognitive-behavioural therapy (Behavioral)

II

Experimental

Treatment as usual + cognitive-behavioural therapy

干预措施: Treatment as usual (Behavioral)

I

Active Comparator

Treatment as usual

干预措施: Treatment as usual (Behavioral)

结局指标

主要结局

PCS symptoms (Rivermead Postconcussion Symptoms Questionnaire)

时间窗: Pre-intervention and three months later

Functional disability (Mayo-Portland Participation Index)

时间窗: Pre-intervention and three months later

次要结局

  • Illness beliefs (Illness Perceptions Questionnaire-Revised)(Pre-intervention and three months later)
  • Coping style (PCS Coping Inventory)(Pre-intervention and three months later)
  • Psychological distress (Hospital Anxiety and Depression Scale) )(Pre-intervention and three months later)
  • Pain (Brief Pain Scale)(Pre-intervention and three months later)
  • Psychiatric diagnosis (MINI International Neuropsychiatric Interview)(Pre-intervention and three months later)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noah Silverberg

Principal Investigator

University of British Columbia

研究点 (1)

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