The Influence of Physical Activity on the Effect of Cognitive Behavioural Therapy, Neurobiological Parameters and Information Processing in Patients With Panic Disorder With/Without Agoraphobia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Hamilton Rating Scale for Anxiety (CIPS 1995)
研究概览
简要总结
Physical activity (treadmill) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia
详细描述
Patients undergo cognitive behavioural therapy consisting of 8 group sessions within 1 month. All patients additionally complete a training of physical activity, which starts simultaneously to therapy and runs for 8 weeks (3 times/week, 30 minutes each). Half of the patients complete training on a treadmill while the other half completes a training programme of low intensity physical activity without cardiovascular activation.
Flanking EEG (electroencephalogram) recordings shall help clarify biological processes underlying the therapeutical process.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject familiarized with experimental procedure and had given written informed consent
- •Diagnosis of panic disorder with or without agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- •Sufficiently able to communicate with investigator, answer questions and fill in questionnaires
- •Reachability of patient for treatment and follow-up
排除标准
- •Other psychiatric illnesses like schizophrenia, substance abuse or severe depressive episode
- •Acute suicidal tendency
- •Epilepsy or other illness of the central nervous system (e.g. brain tumor, encephalitis)
- •Existence of contraindication against physical exercise
- •Pregnancy or breastfeeding
- •Changes of psychopharmacological treatment within the last 4 weeks
结局指标
主要结局
Hamilton Rating Scale for Anxiety (CIPS 1995)
时间窗: up to 28 weeks (follow up)
Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
次要结局
- Panic and Agoraphobia Scale (Bandelow et al. 1995)(Baseline, 4 weeks, 8 weeks and 28 weeks (follow up))
- Beck Anxiety Inventory (CIPS 1995)(Baseline, 4 weeks, 8 weeks and 28 weeks (follow up))
- Clinical Global Index (CIPS 1995)(Baseline, 4 weeks, 8 weeks and 28 weeks (follow up))
- Beck Depression Inventory (CIPS 1995)(Baseline, 4 weeks, 8 weeks and 28 weeks (follow up))
研究者
Prof. Dr. Andreas Ströhle
Prof. Dr.
Charite University, Berlin, Germany