Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD)

Study Overview
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Brief Summary
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This study investigate the effect of high-intense aerobe exercise training (HIT) on clinical and physiological parameters (anxiety, somatisation, cortisol, alpha amylase, mismatch negativity, loudness dependence auditory evoked potentials) in patients with generalized anxiety disorder (GAD). Half of patients will receive HIT, while the other half will receive aerobe exercise of low intensity.

Detailed Description
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Generalized anxiety disorder (GAD) is a prevalent psychiatric condition and characterized by worrying of several topics of the daily life as well as stress-induced somatic symptoms (e.g. headache or musculoskeletal pain). Disturbed monoaminergic neurotransmission, changes in central information processing and altered levels of stress markers were reported as to be biological correlates of GAD or other stress-related disorders. Cognitive behavioral therapy is the first-line treatment in GAD, but it seems to be less effective than in other anxiety disorders. There is, however, some evidence for an anxiolytic activity of aerobe exercise. In this context, different forms of aerobe training were found to be associated with significant reduction of clinical symptoms in panic disorder, agoraphobia or social phobia as well as a normalisation of some of its pathophysiological markers. In this study, 20 patients with GAD will receive a high-intensive aerobe training (HIT, 6 HIT-sessions of 20 minutes within a period of 12 days). Additionally, 20 GAD-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 30 days after baseline, symptoms of anxiety and somatisation will assessed by using established questionnaires. Moreover, saliva samples and electroencephalogram (EEG) will performed at the same times of assessment in order to evaluating changes of cortisol, alpha amylase, mismatch negativity and loudness dependence auditory evoked potentials. We hypothesize, that GAD-patients which undergo HIT, will show a stronger and more sustained improvement of both, clinical symptoms and formally altered electrophysiological and endocrinological parameters.

Official Title
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Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD)

Conditions
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Generalized Anxiety Disorder (GAD)

Intervention / Treatment
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* Other: high-intensive aerobe exercise
* Other: low-intensive aerobe exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generalized Anxiety Disorder (GAD) according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Appropriate abilities to communicate and to complete the questionnaires Written informed consent Possibility of regular attendance at the training sessions Exclusion Criteria: Other severe mental conditions than GAD (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 Cardiovascular diseases Start or modification of an anxiolytic pharmacotherapy within the last four weeks Current psychotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-intensive aerobe exercise<br>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<br>* 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<br>|
| Placebo Comparator: low-intensive aerobe exercise<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Penn State Worry Questionnaire (PSWQ, german version) | PSWQ is a questionnaire for detecting the severity of GAD | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Screening für somatoforme Störungen (SOMS) | SOMS is a questionnaire for detecting the severity of somatisation | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 
| Change in Penn State Worry Questionnaire-past week (PSWQ-PW, german version) | PSWQ-PW is a questionnaire for detecting changes in GAD-severity | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 
| Change in Screening für somatoforme Störungen - 7 Tage (SOMS-7T) | SOMS-7T is a questionnaire for detecting changes in somatisation | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 
| Change in Hamilton Anxiety Rating Scale (HAM-A, german version) | HAM-A is a questionnaire for detecting the severity and changes of anxiety | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 
| Change in Anxiety Control Questionnaire (ACQ, german version) | ACQ is a questionnaire for evaluating the ability to control anxiety | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 
| Change in saliva cortisol | Cortisol is an established marker of the psychophysiological stress response | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 
| Change in saliva alpha amylase | Alpha amylase is an established marker of the psychophysiological stress response | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 
| Change in mismatch negativity | Mismatch negativity is an established correlate of the central information processing | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 
| Change in loudness dependence auditory evoked potentials | Loudness dependence auditory evoked potentials are established correlates of the central serotonergic transmission | From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder, GAD, physical exercise, aerobe exercise, mental disorder, high-intensive aerobe exercise