The Influence of Physical Activity (Prior to In-vivo Exposure) on the Effect of Cognitive Behavioural Therapy in Patients With Panic Disorder and Agoraphobia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 主要终点
- Hamilton Rating Scale for Anxiety (CIPS 1995)
研究概览
简要总结
Physical activity (treadmill) prior to in-vivo exposure supports the effect of cognitive behavioural therapy in patients with panic disorder and agoraphobia.
详细描述
Patients receive a 12-session manualized cognitive behavioural therapy, implemented over 7 weeks and followed by two booster sessions. Five sessions consist of in-vivo exposures. Prior to these sessions patients undergo a training of physical activity. Half of the patients complete training on a treadmill at 70% of their maximal oxygen uptake while the other half complete training at 30%.
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 (Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Subject familiarized with experimental procedure and had given written informed consent
- •Diagnosis of panic disorder with agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- •Score >= 18 in Hamilton Rating Scale for Anxiety
- •Score >= 4 in Clinical Global Index
- •Reachability of patient for treatment and follow-up
排除标准
- •DSM-IV Axis I diagnoses of any psychotic disorder, bipolar disorder, current alcohol or drug dependence and Axis II borderline personality disorder
- •Change in pharmacological treatment in the last 4 weeks
- •Acute suicidality
- •Medical contraindications for mild to moderate exercise training or exposure
结局指标
主要结局
Hamilton Rating Scale for Anxiety (CIPS 1995)
时间窗: Change from Baseline to 31 weeks (follow-up)
Global interviewer rated measure for anxiety and severity indicator of an anxiety disorder
Mobility Inventory (Chambless 1984)
时间窗: Change from Baseline to 31 weeks (follow-up)
A 27-item inventory for the measurement of self-reported agoraphobic avoidance behavior
次要结局
- Clinical Global Index (CIPS 1995)(Baseline, 3 weeks, 7 weeks, 31 weeks (follow up))
- Beck Depression Inventory (CIPS 1995)(Baseline, 3 weeks, 7 weeks, 31 weeks (follow up))
- Anxiety Sensitivity Index (Taylor 1998)(Baseline, every second session, 3 weeks, 7 weeks, 31 weeks (follow up))
- Body Sensations Questionnaire (Chambless 1984)(Baseline, 3 weeks, 7 weeks, 31 weeks (follow up))
- Agoraphobic Cognitions Questionaire (Chambless 1984)(Baseline, 3 weeks, 7 weeks, 31 weeks (follow up))
- Panic and Agoraphobia Scale(Change from baseline to 31 weeks (follow-up))
研究者
Prof. Dr. Andreas Ströhle
Prof. Dr.
Charite University, Berlin, Germany