Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte
Berlin, 10117, Germany
NCT Number: NCT02662803
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Berlin, 10117, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
PSWQ is a questionnaire for detecting the severity of GAD
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
SOMS is a questionnaire for detecting the severity of somatisation
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
PSWQ-PW is a questionnaire for detecting changes in GAD-severity
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
SOMS-7T is a questionnaire for detecting changes in somatisation
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
HAM-A is a questionnaire for detecting the severity and changes of anxiety
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
ACQ is a questionnaire for evaluating the ability to control anxiety
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Cortisol is an established marker of the psychophysiological stress response
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Alpha amylase is an established marker of the psychophysiological stress response
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Mismatch negativity is an established correlate of the central information processing
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Loudness dependence auditory evoked potentials are established correlates of the central serotonergic transmission
Charite University, Berlin, Germany
Other
Acronym: GAD_exercise
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