Mechanisms of CBT-Treatment Effects in Patients With Panic Disorder and Panic Disorder With Agoraphobia: The Role of Interoceptive Exposure
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Hamilton Anxiety Rating Scale (HARS)
研究概览
简要总结
Investigation of mechanisms of exposure based learning by
- Investigating the effects of fear augmentation by interoceptive exposure during in vivo exposure
- Disentangling the effects of interoceptive exposure exercises in panic disorder
详细描述
The study aims on investigating the effect of fear augmentation during in-vivo exposure by adding interoceptive exposure (e.g., hyperventilation) in PD/AG patients. By comparing the fear augmentation group with the therapist-guided CBT exposure, and by measuring autonomic arousal during and between exposure sessions, it will be possible to study the mechanisms of exposure based learning. A second aim is to disentangle effects of specific interoceptive exposure exercises (e.g., respiratory vs. vestibular stimulation). Finally, by including patients without agoraphobic avoidance it will be possible to investigate whether interoceptive exposure alone will have any effect. This might open the door for early interventions for individuals after experiencing an initial panic attack to prevent the development of a severe panic disorder with agoraphobic avoidance.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old
- •Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of panic disorder, panic disorder with agoraphobia OR initial panic attacks
- •CGI ≥ 4 (except persons with initial panic attacks)
- •Informed Consent
排除标准
- •Acute suicidality
- •Current substance use disorder
- •Lifetime diagnosis of psychotic disorders, bipolar disorders, borderline personality disorders
- •Severe medical condition (chronic conditions)
- •Current psychotherapeutic or psychopharmacological treatment
结局指标
主要结局
Hamilton Anxiety Rating Scale (HARS)
时间窗: up to 32 weeks (follow up)
structured clinician rating assessing the severity of an anxiety disorder
Clinician Global Impression Scale (CGI)
时间窗: up to 32 weeks (follow up)
clinician rating assessing the severity of panic disorder and agoraphobia
Panic and Agoraphobia Scale (PAS)
时间窗: up to 32 weeks (follow up)
PAS is self-rating assessing panic disorder and agoraphobia severity with five factor analytic derived subscale scores (panic attacks, anticipatory anxiety, agoraphobic avoidance, health concerns, functional impairment) and a total score indicating the global severity. The questionnaire was specifically developed for monitoring changes during psychotherapy or psychopharmacological treatments.
Mobility Inventory
时间窗: up to 32 weeks (follow up)
Self-rating assessing the extent of situational avoidance. The questionnaire comprises 27 situations that have to be evaluated in regard to frequency of avoidance, when alone or when accompanied.
Number of panic attacks
时间窗: up to 32 weeks (follow up)
Number of panic attacks experienced during the last week is assessed.
次要结局
未报告次要终点