Effects of Physical Exercise on Anxiety and Co-morbid Emotional Disturbances: A Clinical Trail in a Day Care Unit
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Mobility Inventory (MI) - Alone & Accompanied
研究概览
简要总结
The purpose of this study is to compare manualised physical exercise conducted in groups to manualised cognitive-behavioral therapy conducted in groups as treatment for panic disorder with or without agoraphobia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained
- •Clinical diagnosis of panic disorder with and without agoraphobia according to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR, 4th ed., text revision; American Psychiatric Association, 2000), established through administration of Structural Clinical Interview for DSM-IV axis I disorders (SCID I; First, Spitzer, Gibbon, & Williams, 1995).
排除标准
- •Brain-organic disorders according to DSM-IV-TR
- •The presence of psychotic disorders according to DSM-IV-TR, established through administration of SCID I
- •Present substance-abuse
- •Medical condition that excludes participation in physical activity
- •Major Depressive Disorder according to DSM-IV-TR established through administration of SCID I.
研究组 & 干预措施
Physical exercise
Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
干预措施: Physical exercise (Behavioral)
Cognitive-behavioral therapy
Cognitive-behavioral therapy conducted in groups (5-8 participants per group). 1 session (á 2-2.25 hours depending on group size) per week for 12 consecutive weeks
干预措施: Cognitive-behavioral therapy (Behavioral)
结局指标
主要结局
Mobility Inventory (MI) - Alone & Accompanied
时间窗: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Agoraphobic Cognitions Questionnaire (ACQ)
时间窗: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Body Sensations Questionnaire
时间窗: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Panic frequency - Self-report & Clinician-rating
时间窗: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
Panic distress/disability - Self-report & Clinician-rating
时间窗: Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up
次要结局
- Beck Anxiety Inventory (BAI)(Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up)
- State-Trait Anxiety Inventory - State & Trait (STAI S/T)(Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up)
- Beck Depression Inventory II (BDI-II)(Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up)
- Quality of Life Inventory (QoLI)(Baseline; Pre-treatment; Post-treatment; 6-months follow-up; 12-monthts follow-up)