Generalized Anxiety Disorder (GAD)
Conditions
Keywords
Generalized Anxiety Disorder, GAD, physical exercise, aerobe exercise, mental disorder, high-intensive aerobe exercise
Brief summary
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
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.
Interventions
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
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Penn State Worry Questionnaire (PSWQ, german version) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Penn State Worry Questionnaire-past week (PSWQ-PW, german version) | 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 |
| Change in Screening für somatoforme Störungen - 7 Tage (SOMS-7T) | 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 |
| Change in Hamilton Anxiety Rating Scale (HAM-A, german version) | 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 |
| Change in Anxiety Control Questionnaire (ACQ, german version) | 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 |
| Change in Screening für somatoforme Störungen (SOMS) | 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 |
| Change in saliva alpha amylase | 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 |
| Change in mismatch negativity | 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 |
| Change in loudness dependence auditory evoked potentials | 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 |
| Change in saliva cortisol | 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 |
Countries
Germany
Outcome results
None listed