Effect of Cognitive-behavior Therapy on Panic Symptomatology and the Activation of the Brain's Fear Network to Panic-related Body Symptoms in Patients With Panic Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in panic symptomatology and severity (PAS)
研究概览
简要总结
The present study aims to investigate a potential mechanism of successful CBT for panic disorder, i.e., the reduction of excessive anxious apprehension and fear responses to panic-related body symptoms in the context of CBT treatment. In the present non-randomized interventional study, effects of cognitive behavior therapy on reported symptoms and fear responses to panic-related body symptoms are investigated. It is expected that symptom improvement during CBT is associated with a decrease in the activation of the brain's fear network to panic-related body symptoms.
详细描述
Changes in fear responses to body symptoms in the course of CBT are investigated in patients with PD by applying a highly standardized hyperventilation task (provoking panic-related body symptoms) prior to and after a manualized CBT or a waiting period. Activation of the brain's fear network (defensive activation) is indexed by the potentiation of the startle eyeblink response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (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
- •current primary diagnosis of panic disorder (with or without agoraphobia) as defined by the criteria of the diagnostic and statistical manual, fourth revision/text revision (DSM-IV-TR) (determined using the Composite International Diagnostic Interview and verified by a certified psychotherapist)
- •age 18 - 65 years
排除标准
- •current suicidal intent
- •any psychotic or bipolar disorder
- •borderline personality disorder
- •a medical condition that could explain patients' symptoms
- •physical contradictions regarding application of exposure-based CBT (e.g., neurological disease)
- •Patients has to be on a stable psychopharmacological medication schedule prior to study entry for at least 12 weeks
- •Intake of benzodiazepines
研究组 & 干预措施
Exposure-based cognitive-behavior therapy
Patients are treated in accordance with a manualized protocol (Gloster et al., 2011)
干预措施: Cognitive-behavior therapy (Behavioral)
Wait-List control condition
Patients are assessed prior to and after a 12-week waiting period. Patients are treated after this 12-week delay.
结局指标
主要结局
Change in panic symptomatology and severity (PAS)
时间窗: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
The Panic and Agoraphobia Scale (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. Total score range: 0 to 57. Higher scores indicate worse severity of panic symptomatology.
Change in anxiety sensitivity (ASI)
时间窗: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
The Anxiety Sensitivity Index (ASI) is a self-report measure of fear of anxiety-related body symptoms (i.e., anxiety sensitivity). Total score range: 0 to 64. Higher scores indicate worse anxiety sensitivity.
Change in the severity of anxiety symptomatology (HAM-A=
时间窗: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
The Hamilton Anxiety Rating Scale (HAM-A) is a structured clinician rating assessing the severity of anxiety symptomatology. Total score rage: 0 to 56. Higher scores indicate worse severity of anxiety symptomatology.
Change in defensive activation to interoceptive threat
时间窗: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Defensive activation to interoceptive threat (induced via a standardized hyperventilation task) is assessed using the startle eyeblink response (measured via electromyographic activity over the left musculus orbicularis oculi) to an acoustic startle probe.
次要结局
- Change in agoraphobic avoidance (MI)(change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period)
- Change in Clinical global impression (CGI) (adapted for panic disorder symptomatology)(change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period)
- Change in fear of body symptoms (BSQ)(change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period)
- Change in depression symptomatology (BDI)(change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period)
- Change in Agoraphobic Cognitions (ACQ)(change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period)
研究者
Christane Pané-Farré
Prof. Dr. Christiane Pané-Farré
Philipps University Marburg Medical Center