CBT-Training Zur Kognitiven Umbewertung Als Lntervention Bei Patienten*Innen Mit Funktionellem Tremor - Eine EEG-Studie
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Clinical health - Clinical Global Impression Severity Scale
研究概览
简要总结
The aim of this psychological study is to evaluate the effect of a cognitive behavioral therapy (CBT) intervention aimed at improving cognitive reappraisal on (1) Clinical and Self-Rated Health according to Patient Global Impression-Change (PGI-C), Patient Global Impression-Severity (PGI-S), Clinical Global Impression-Change (CGI-C) and Clinical Global Impression-Severity (CGI-S) after 4 weeks, (2) the change in the severity of the functional movement disorder/tremor as assessed by a blinded clinician using the Simplified Version of the Psychogenic Movement Disorders Rating Scale (S-FMDRS) after 4 weeks and (3) the change in the severity of functional tremor assessed via the Fahn Tolosa Marin Tremor Rating Scale (FTM) after 4 weeks.
The knowledge gained about the introspective and neurobiological effect of this cognitive behavioral therapy intervention should enable improved therapy options for patients with functional tremor / functional motor disorders in the future.
详细描述
This is an intervention study including patients of the outpatient clinic for movement disorders at the University Clinic of Neurology in Graz.
The patients will randomly be assigned to the intervention (cognitive reappraisal) or control (reflection) group.
The study consists of a first preliminary examination at the University clinic, followed by an electroencephalogram (EEG)-lab-session at the Institute of Psychology of the Karl-Franzens-University of Graz. The patients will complete emotion-regulation tasks while the EEG is conducted and then be introduced to an App, with which they will either complete 14 cognitive-reappraisal-tasks (intervention) or 14 reflection-tasks (control) within the next 4 weeks. A task will need to be completed in the App once every two days.
After this training period, there will be a second preliminary examination at the University Clinic as well as a second subsequent EEG-lab-sessions at the Institute of Psychology at the Karl-Franzens-University.
In addition, after two weeks of training, the patients will receive a short phone call and will be asked to complete the PGI-S and PGI-C.
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
The patients are randomly assigned to a group and do not know whether that is the intervention or the control group.
The physicians conducting the preliminary assessments do not know which group the patient was placed in.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Diagnosis of a functional movement disorder
排除标准
- •The patient is not capable of giving consent.
- •The patient does not have sufficient knowledge of German to answer the questionnaires (questionnaires are only available in German).
研究组 & 干预措施
Cognitive Reappraisal
The intervention group completes CBT-training to improve their cognitive reappraisal and emotion-regulation-skills.
干预措施: Cognitive Reappraisal (Behavioral)
Reflection
The control group completes tasks based on reflection about their daily lifes, which should have no impact on their emotion-regulation-skills or functional motor disorder.
干预措施: Reflection (Behavioral)
结局指标
主要结局
Change in Clinical health - Clinical Global Impression Severity Scale
时间窗: 4 weeks
Clinical health according to Clinical Global Impression of Severity Scale (CGI-S) rated by a medical professional. Three questions regarding patients current mood, influence of the symptoms on everyday motor function and overall severity. Answer options: 1. Not at all/very easy 2. Lightly 3. Moderate 4. Strong 5. Very strong Higher values = worse outcome
Change in Self-assessed health - Patient Global Impression of Change
时间窗: 4 weeks
Self-assessed health according to Patient Gloabal Impression of Change Scale (PGI-C) rated by the patients themselves. Three questions regarding patients mood, everyday bodily function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options: Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better Higher values = better outcome
Change in Clinical health - Clinical Global Impression of Change
时间窗: 4 weeks
Clinical health according to Clinical Global Impression of Change Scale (CGI-C) rated by a medical professional. Three questions regarding patients mood, everyday motor function and overall change as well as a rating regarding the relevance of the change (Yes or No). Answer options: Very Much worse Much worse Slightly worse No change Marginally better Much better Very Much better Higher values = better outcome
Change in Self-assessed health - Patient Global Impression Severity Scale
时间窗: 4 weeks
Self-assessed health according to Patient Global Impression of Severity Scale (PGI-S) rated by the patients themselves. Three questions regarding patients current mood, influence of the symptoms on everyday bodily function and overall severity. Answer options: 1. Not at all/very easy 2. Lightly 3. Moderate 4. Strong 5. Very strong Higher values = worse outcome
The change in severity of the functional movement disorder
时间窗: 4 weeks
The change in severity as assessed by a blinded clinician using the severity of the functional movement disorder by means of the Simplified Version of the Psychogenic Movement Disorders Rating Scale (S-FMDRS). Scoring: 0-3, higher values indicate worse outcome.
The change in tremor severity
时间窗: 4 weeks
The change in tremor severity assessed using the Fahn Tolosa Marin Tremor-Rating-Scale. Scoring: 0-4, higher values indicate worse outcome.
次要结局
- Long-term change in Self-assessed health - Patient Global Impression of Change(8 weeks)
- Changes in patients EEG-activity.(4 weeks)
- Change in the ability of emotion regulation(4 weeks)
- Long-term change in Self-assessed health - Patient Global Impression Severity Scale(8 weeks)
- Change in the patients Welfare- Health Questionnaire EQ-5D-5L.(4 weeks)
- Change in the patients Welfare- Short Form Health Questionnaire(4 weeks)
- Change in the patients Welfare - Psychosomatic Assessment Health-DISC. Minimum value in each section: 0 Maximum value in each section: 10 Higher scores = better outcome.(4 weeks)
- Change in patients personality and behavioral aspects(4 weeks)
- Change in the patients Creativity(4 weeks)