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临床试验/NCT02690584
NCT02690584已完成不适用

Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire

研究概览

简要总结

The purpose of this open trial is to investigate the feasibility, acceptability, and effect of metacognitive therapy in patients with prolonged post-concussive symptoms after mild traumatic brain injury.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire

时间窗: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after completed therapy

次要结局

  • Symbol Digit Modality Test(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Resilience scale for Adults (RSA)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Conners CPT-III(2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • D-KEFS Trail Making Test(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Color-Word Interference Test(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • D-KEFS Verbal Fluency(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Behavior Rating Inventory-Adult version (BRIEF-A)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • The metacognitive beliefs questionnaire (MCQ-30)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Fatigue questionnaire (FQ)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Brief Pain Inventory (BPI)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Inventory of Interpersonal Problems 64 (IIP-64)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Fatigue severity scale (FSS)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • SF-12(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Epworth sleepiness scale (ESS)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Cognitive Attention Syndrome (CAS-1)(3 pre-treatment baseline measures, session to session (10 sessions), immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Insomnia severity Index (ISI)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Beck Depression Inventory (BDI)(3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
  • Beck Anxiety Inventory (BAI)(3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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