Performance Anxiety Changes With Exercise

Performance Anxiety Clinical Trial

— PACE  

Official title:

Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562312
• Other study ID #: EA114217
• Status: Completed
• Phase: N/A
• Start date: May 3, 2018
• Est. completion date: April 14, 2020

Study information

• Verified date: April 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 14, 2020
• Est. primary completion date: April 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Performance Anxiety

Intervention

Other:
• high-intensive aerobe exercise
Aerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days
• low-intensive aerobe exercise
Aerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Friede Springer Stiftung, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bühnenangstfragebogen	Bühnenangstfragebogen is a questionnaire measuring Music Performance Anxiety. It is the German Version of the PAQ (Performance Anxiety Questionnaire)	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	Screening für somatoforme Störungen (SOMS-7T)	SOMS-7T is a questionnaire for detecting the changes in somatisation	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	Screening für somatoforme Störungen (SOMS-2)	SOMS-2 is a questionnaire for detecting the severity of somatisation	Only one assessment at baseline to assess differences between the two intervention groups
Secondary	NEO-FFI personality inventory	personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness	Only one assessment at baseline to assess differences between the two intervention groups
Secondary	Resilienzskala (RS-13)	A Questionnaire measuring resilience	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	Trierer Inventar zum chronischen Stress (TICS)	TICS is an inventory measuring chronic stress	Only one assessment at baseline to assess differences between the two intervention groups
Secondary	Angstkontrollfragebogen (AKF)	AKF is the German Version of the Anxiety Control Questionnaire	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	Anxiety Sensitivity Index (ASI)	ASI is a Questionnaire measuring anxiety sensitivity	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	Beck Anxiety Inventory (BAI)	BAI is a questionnaire measuring anxiety	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	Beck Depression Inventory (BDI)	BDI is a questionnaire measuring depression	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	Liebowitz Social Anxiety Scale (LSAS)	LSAS is a questionnaire measuring social anxiety	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	Fragebogen zu sozialphobischen Kognitionen (SPK)	SPK is the German Version of the social cognitions questionnaire. It measures cognitions in social situations	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	saliva cortisol hormone	Cortisol is an established marker of the psychophysiological stress response and obtained with help of Salivettes absorbing saliva	Change from Baseline to post therapy (+12 days) and in performance situations 1 and 2 (+15 days)
Secondary	saliva alpha Amylase hormone	Alpha amylase is an established marker of the psychophysiological stress Response and obtained with help of Salivettes absorbing saliva	From Baseline to post therapy (+12 days) and during performance situations 1 (Baseline) and 2 (+15 days)
Secondary	heart rate	Measurement of 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)
Secondary	heart rate variability	heart rate variability is a non-invasive method to measure autonomic nervous System function	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)
Secondary	visual analogue scale for anxiety (VAS)	VAS is a scale measuring an individual's anxiety in a specific situation	Change during performance situations 1 (baseline) and 2 (+15 days)
Secondary	Accelerometer	With help of an accelerometer the activity level of a person can be measured	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	International Physical Activity Questionnaire (IPAQ-SF)	With the IPAQ-SF the physical activity of an individual during the last 7 days can be measured	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary	K-MPAI	Kenny Music Performance Anxiety Inventory is a questionnaire measuring Music Performance Anxiety	Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)