Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Bühnenangstfragebogen
研究概览
简要总结
This study investigates the effect of high-intense aerobe exercise training (HIIT) and aerobe exercise of low intensity on clinical and physiological parameters (anxiety, activity, cortisol, alpha amylase, heart rate, heart rate variability, spiroergometry) in patients with Music Performance Anxiety (MPA). Half of the patients will receive HIIT, while the other half will receive aerobe exercise of low intensity.
详细描述
In this study, 20 patients with MPA will receive a high-intensive aerobe training (HIIT, 6 HIIT-sessions of 20 minutes within a period of 12 days). Additionally, 20 MPA-patients will undergo a less intense aerobe training matched regarding frequency and duration of sessions. Prior to the first training session, after completing the training (day 12) and 10 days after the Training (day 22), symptoms of anxiety and will be assessed by using questionnaires. Moreover, heart rate and heart rate variability will be obtained and activity level is measured using accelerometers. Before and after the training there will be an assessment of saliva samples for measuring cortisol and alpha amylase.
Furthermore, a standardized performance situation is established before and after the Training. Before, during and after the performance anxiety ratings, cortisol, alpha amylase, heart rate and heart rate variability are assessed.
The investigators hypothesize, that patients with MPA which undergo HIIT, will show a stronger and more sustained improvement of both, clinical symptoms and physiological measures. Specifically, a decreased heart rate, higher heart rate variability and decreased endocrinological parameters.
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 (Participant)
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
- •Diagnosis of social anxiety disorder, Performance only subtype due to DSM-5
- •Appropriate abilities to communicate and to complete the questionnaires
- •Written informed consent
- •Possibility of regular attendance at the training sessions
- •Participant is a classical instrumentalist
排除标准
- •Other severe mental conditions than MPA (e.g. schizophrenia, severe depressive episode, addiction)
- •Acute suicidality
- •Epilepsy or other disorders of the central nervous system (e.g. tumor, encephalitis)
- •Contraindications to aerobe exercise Training
- •Start or modification of an anxiolytic pharmacotherapy or other therapy within the last four weeks
- •Current psychotherapy
- •no sufficient capability to consent to trial
结局指标
主要结局
Bühnenangstfragebogen
时间窗: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Bühnenangstfragebogen is a questionnaire measuring Music Performance Anxiety. It is the German Version of the PAQ (Performance Anxiety Questionnaire)
次要结局
- Beck Depression Inventory (BDI)(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- Screening für somatoforme Störungen (SOMS-7T)(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- Screening für somatoforme Störungen (SOMS-2)(Only one assessment at baseline to assess differences between the two intervention groups)
- NEO-FFI personality inventory(Only one assessment at baseline to assess differences between the two intervention groups)
- Resilienzskala (RS-13)(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- Trierer Inventar zum chronischen Stress (TICS)(Only one assessment at baseline to assess differences between the two intervention groups)
- Angstkontrollfragebogen (AKF)(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- Anxiety Sensitivity Index (ASI)(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- Beck Anxiety Inventory (BAI)(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- Liebowitz Social Anxiety Scale (LSAS)(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- Fragebogen zu sozialphobischen Kognitionen (SPK)(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- saliva cortisol hormone(Change from Baseline to post therapy (+12 days) and in performance situations 1 and 2 (+15 days))
- saliva alpha Amylase hormone(From Baseline to post therapy (+12 days) and during performance situations 1 (Baseline) and 2 (+15 days))
- heart rate(Change from Baseline to post therapy (+12 days), from Baseline to Follow-up and during performance situations 1 (Baseline) and 2 (+15 days))
- heart rate variability(Change from Baseline to post therapy (+12 days), from Baseline to follow-up (+22 days) and during performance situations 1 (Baseline) and 2 (+15 days))
- visual analogue scale for anxiety (VAS)(Change during performance situations 1 (baseline) and 2 (+15 days))
- Accelerometer(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- International Physical Activity Questionnaire (IPAQ-SF)(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
- K-MPAI(Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days))
研究者
Dr. Jens Plag
MD
Charite University, Berlin, Germany