Performance Anxiety Changes With Exercise (PACE)

• ClinicalTrials.gov Identifier: NCT03562312
• Recruitment Status: Completed
• First Posted: June 19, 2018
• Last Update Posted: April 15, 2020
• Sponsor: Charite University, Berlin, Germany
• Collaborator: Friede Springer Stiftung, Germany
• Information provided by (Responsible Party): Dr. Jens Plag, Charite University, Berlin, Germany

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Performance Anxiety	Other: high-intensive aerobe exercise; Other: low-intensive aerobe exercise	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety
• Actual Study Start Date: May 3, 2018
• Actual Primary Completion Date: April 14, 2020
• Actual Study Completion Date: April 14, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	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
Placebo Comparator: 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	Other: 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

Outcome Measures

Primary Outcome Measures :

1. Bühnenangstfragebogen [ Time Frame: 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)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte

Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Friede Springer Stiftung, Germany

Investigators

• Study Chair: Alexander Schmidt; Charite University, Berlin, Germany

More Information

• Responsible Party: Dr. Jens Plag, MD, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT03562312
• Other Study ID Numbers: EA114217
• First Posted: June 19, 2018
• Last Update Posted: April 15, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Jens Plag, Charite University, Berlin, Germany:

MPA; Music Performance Anxiety; HIIT; Exercise; Cortisol; HRV; Heart Rate

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders