NCT02690584已完成不适用
Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury
适应症
干预措施
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
- 否
入选标准
- •Patients with prolonged recovery after mild TBI (GCS >12) will be recruited to our study if they have post concussive symptoms > 6 months after injury.
- •Patients will be recruited from an ongoing cohort study investigating mild and moderate TBI at St. Olavs Hospital and Trondheim Municipality Emergency Clinic, and in addition (as of October 2017) among TBI patients at St Olavs Hospital who were not included in the cohort study.
- •Inclusion criteria
- •Aged ≥between 16 and < 60 years
- •Have sustained a traumatic brain injury
排除标准
- •Severe TBI (GCS score 8 or less)
- •Non fluency in Norwegian
- •Living outside of Norway
- •Major other trauma with high risk of disability lasting more than 3 months.
- •Major incidental intracranial findings in acute MRI e.g. cyst, tumor, malformation, infarctions.
- •Severe psychiatric, neurological or medical disease, including: Psychotic disorders, bipolar disorder, ongoing severe depressive episode
- •Personality disorders affecting adherence to the research protocol
- •Alcohol/drug abuse affecting adherence to the research protocol
- •Mental retardation, autism or other severe developmental disorders
- •Prior complicated mild, moderate or severe TBI
- •Stroke or other acquired brain injuries
- •Progressive neurological disorders (e.g. Parkinson's disease, MS)
- •Advanced cancer, heart- or respiratory disease or other somatic diseases that interfere with function.
- •Major other trauma e.g. spinal cord injury
- •In addition to exclusion criteria already employed in the cohort study, patients with co-occurring psychiatric disorders that necessitate referral to specific treatment according to existing guidelines will be excluded from the current intervention study.
研究组 & 干预措施
Metacognitive therapy
Experimental
Metacognitive therapy, one 45-60 min session weekly during 10 weeks.
干预措施: Metacognitive therapy (Behavioral)
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
- 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)
- 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)
- 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)
- Conners CPT-III(2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
- 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)
- 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)
研究者
研究点 (1)
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