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Completed

NCT Number: NCT03562312

Performance Anxiety Changes With Exercise

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.

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Key information

Conditions

Performance Anxiety Behavior Motor Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high-intensive aerobe exercise

Other

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

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Friede Springer Stiftung, Germany

Registry information

Official study title

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

Acronym: PACE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2018
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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