Dynamic Treatment vs. CBT for Panic Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- Panic Disorder Severity Scale
研究概览
简要总结
This study will determine the relative effectiveness of three psychotherapies in treating people with a panic disorder.
详细描述
Panic disorder (PD) is a debilitating anxiety disorder. It is characterized by unexpected and repeated episodes of intense fear, accompanied by serious physical symptoms, such as chest pain, heart palpitations, shortness of breath, dizziness, or abdominal stress. Available treatments for PD include medication therapy and cognitive behavioral therapy (CBT), a type of psychotherapy that teaches people how to view panic attacks differently and how to reduce anxiety. Approximately 30% of patients refuse medication, however, and nearly 50% do not achieve remission with CBT alone. Therefore, there is a pressing need for additional non-pharmacologic treatment methods. Panic-focused psychodynamic psychotherapy (PFPP) and applied relaxation training (ART) are among some of the other available treatments for PD. During ART, individuals are taught to relax their muscles while being exposed to increasingly frightening situations. PFPP combines elements of CBT with other, more extensive approaches aimed at determining the anxiety's origin and at finding ways to reduce it. This study will compare the effectiveness of PFPP, CBT, and ART in treating PD.
Participants in this single blind study will be randomly assigned to receive PFPP, CBT, or ART for 12 weeks. All participants will attend between 19 and 24 treatment sessions over the course of the study. Upon completing the study, participants will attend monthly follow-up visits for an additional 12 months. Participants assigned to ART who have not responded by the end of treatment may opt to receive PFPP or CBT. Outcomes will be assessed using a variety of scales to determine depression and anxiety symptoms.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV diagnosis criteria for primary PD with or without agoraphobia
- •History of at least one spontaneous panic attack per week within the month prior to study entry
排除标准
- •Active substance dependence within 6 months prior to study entry
- •Lifetime history of any psychotic disorder, including bipolar disorder
- •Acutely suicidal
结局指标
主要结局
Panic Disorder Severity Scale
时间窗: 12 weeks
A composite score of panic severity. High value = 28, lowest value =0. Higher=worse
次要结局
- Sheehan Disability Scale(12 weeks)
- Anxiety Disorder Sensitivity Index(12 weeks)
- Panic-Specific Reflective Function(12 weeks)
- Hamilton Depression Rating Scale(12 weeks)
- Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)(12 weeks)
- Clinical Global Impressions Scale(12 weeks)
- Hamilton Anxiety Rating Scale(12 weeks)
