Clinical trial NCT03562312: Performance Anxiety Changes With Exercise
Official title: Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance Anxiety
Keywords: MPA
Music Performance Anxiety
HIIT
Exercise
Cortisol
HRV
Heart Rate
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Friede Springer Stiftung, Germany
First posted: 2018-06-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Bühnenangstfragebogen
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary outcomes:
measure: Screening für somatoforme Störungen (SOMS-7T)
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: Screening für somatoforme Störungen (SOMS-2)
timeFrame: Only one assessment at baseline to assess differences between the two intervention groups
measure: NEO-FFI personality inventory
timeFrame: Only one assessment at baseline to assess differences between the two intervention groups
measure: Resilienzskala (RS-13)
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: Trierer Inventar zum chronischen Stress (TICS)
timeFrame: Only one assessment at baseline to assess differences between the two intervention groups
measure: Angstkontrollfragebogen (AKF)
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: Anxiety Sensitivity Index (ASI)
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: Beck Depression Inventory (BDI)
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: Fragebogen zu sozialphobischen Kognitionen (SPK)
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: saliva cortisol hormone
timeFrame: Change from Baseline to post therapy (+12 days) and in performance situations 1 and 2 (+15 days)
measure: saliva alpha Amylase hormone
timeFrame: From Baseline to post therapy (+12 days) and during performance situations 1 (Baseline) and 2 (+15 days)
measure: heart rate
timeFrame: Change from Baseline to post therapy (+12 days), from Baseline to Follow-up and during performance situations 1 (Baseline) and 2 (+15 days)
measure: heart rate variability
timeFrame: 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)
measure: visual analogue scale for anxiety (VAS)
timeFrame: Change during performance situations 1 (baseline) and 2 (+15 days)
measure: Accelerometer
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: International Physical Activity Questionnaire (IPAQ-SF)
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
measure: K-MPAI
timeFrame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Alexander Schmidt
role: STUDY_CHAIR
References: