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Completed

NCT Number: NCT02662803

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

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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Key information

Age range

18 year and older

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

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.

Who can participate

Healthy volunteers accepted: No

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

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

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. Change in Penn State Worry Questionnaire (PSWQ, german version)

    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

Secondary outcomes

  1. Change in Screening für somatoforme Störungen (SOMS)

    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

  2. Change in Penn State Worry Questionnaire-past week (PSWQ-PW, german version)

    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

  3. Change in Screening für somatoforme Störungen - 7 Tage (SOMS-7T)

    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

  4. Change in Hamilton Anxiety Rating Scale (HAM-A, german version)

    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

  5. Change in Anxiety Control Questionnaire (ACQ, german version)

    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

  6. Change in saliva cortisol

    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

  7. Change in saliva alpha amylase

    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

  8. Change in mismatch negativity

    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

  9. Change in loudness dependence auditory evoked potentials

    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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: GAD_exercise

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2016
Registry last updated
Feb 5, 2019

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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