Generalized Anxiety Disorder (GAD)GAD_exerciseNCT02662803
Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD)
A study testing high-intensive aerobe exercise and low-intensive aerobe exercise in people with Generalized Anxiety Disorder (GAD), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- What is being tested?
- high-intensive aerobe exercise and low-intensive aerobe exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte
Berlin, 10117
About this study
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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder (GAD)
- Being tested
- high-intensive aerobe exercise, low-intensive aerobe exercise
- Keywords
- Generalized Anxiety Disorder, GAD, physical exercise, aerobe exercise, mental disorder, high-intensive aerobe exercise
- Medical subject headings
- Generalized Anxiety Disorder, Motor Activity, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensive aerobe exerciseOther
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 exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| high-intensive aerobe exercise | Experimental | 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 Receives: Other: high-intensive aerobe exercise |
| low-intensive aerobe exercise | Placebo comparator | 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 Receives: Other: low-intensive aerobe exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Penn State Worry Questionnaire (PSWQ, german version)
PSWQ is a questionnaire for detecting the severity of GAD
Measured: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Secondary outcomes (9)
Change in Screening für somatoforme Störungen (SOMS)
SOMS is a questionnaire for detecting the severity of somatisation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jens Plag, Charite University, Berlin, Germany
- Investigators
- Plag JP Plag, Dr., Study chair, Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662803
- Sponsor's protocol ID
- EA1/217/15
- Acronym
- GAD_exercise
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2016
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gaudlitz K, Plag J, Dimeo F, Strohle A. Aerobic exercise training facilitates the effectiveness of cognitive behavioral therapy in panic disorder. Depress Anxiety. 2015 Mar;32(3):221-8. doi: 10.1002/da.22337. Epub 2014 Dec 17.
PubMed 25515221Ghisolfi ES, Heldt E, Zanardo AP, Strimitzer IM Jr, Prokopiuk AS, Becker J, Cordioli AV, Manfro GG, Lara DR. P50 sensory gating in panic disorder. J Psychiatr Res. 2006 Sep;40(6):535-40. doi: 10.1016/j.jpsychires.2006.02.006. Epub 2006 Apr 17.
PubMed 16616936Hegerl U, Juckel G. Intensity dependence of auditory evoked potentials as an indicator of central serotonergic neurotransmission: a new hypothesis. Biol Psychiatry. 1993 Feb 1;33(3):173-87. doi: 10.1016/0006-3223(93)90137-3.
PubMed 8383545Clark CR, McFarlane AC, Weber DL, Battersby M. Enlarged frontal P300 to stimulus change in panic disorder. Biol Psychiatry. 1996 May 15;39(10):845-56. doi: 10.1016/0006-3223(95)00288-x.
PubMed 9172705Naatanen R. The mismatch negativity: a powerful tool for cognitive neuroscience. Ear Hear. 1995 Feb;16(1):6-18.
PubMed 7774770Plag J, Gaudlitz K, Schumacher S, Dimeo F, Bobbert T, Kirschbaum C, Strohle A. Effect of combined cognitive-behavioural therapy and endurance training on cortisol and salivary alpha-amylase in panic disorder. J Psychiatr Res. 2014 Nov;58:12-9. doi: 10.1016/j.jpsychires.2014.07.008. Epub 2014 Jul 21.
PubMed 25085607Schumacher S, Kirschbaum C, Fydrich T, Strohle A. Is salivary alpha-amylase an indicator of autonomic nervous system dysregulations in mental disorders?--a review of preliminary findings and the interactions with cortisol. Psychoneuroendocrinology. 2013 Jun;38(6):729-43. doi: 10.1016/j.psyneuen.2013.02.003. Epub 2013 Mar 5.
PubMed 23481259Burgomaster KA, Hughes SC, Heigenhauser GJ, Bradwell SN, Gibala MJ. Six sessions of sprint interval training increases muscle oxidative potential and cycle endurance capacity in humans. J Appl Physiol (1985). 2005 Jun;98(6):1985-90. doi: 10.1152/japplphysiol.01095.2004. Epub 2005 Feb 10.
PubMed 15705728Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
PubMed 2076086Stober J, Bittencourt J. Weekly assessment of worry: an adaptation of the Penn State Worry Questionnaire for monitoring changes during treatment. Behav Res Ther. 1998 Jun;36(6):645-56. doi: 10.1016/s0005-7967(98)00031-x.
PubMed 9648338Maier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988 Jan-Feb;14(1):61-8. doi: 10.1016/0165-0327(88)90072-9.
PubMed 2963053Plag J, Schumacher S, Strohle A. [Generalized anxiety disorder]. Nervenarzt. 2014 Sep;85(9):1185-94. doi: 10.1007/s00115-014-4121-8. German.
PubMed 25119343Jayakody K, Gunadasa S, Hosker C. Exercise for anxiety disorders: systematic review. Br J Sports Med. 2014 Feb;48(3):187-96. doi: 10.1136/bjsports-2012-091287. Epub 2013 Jan 7.
PubMed 23299048
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD)
- ClinicalTrials.gov ID
- NCT02662803
- Acronym / sponsor ID
- GAD_exercise / EA1/217/15
- Conditions
- Generalized Anxiety Disorder (GAD)
- Keywords
- Generalized Anxiety Disorder, GAD, physical exercise, aerobe exercise, mental disorder, high-intensive aerobe exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensive aerobe exercise | Experimental | Other: high-intensive aerobe exerciseAerobe 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 | Placebo comparator | Other: low-intensive aerobe exerciseAerobe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-intensive aerobe exerciseAerobe 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 |
| low-intensive aerobe exerciseAerobe 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 |
Primary outcome
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
9 secondary outcomes
Change in Screening für somatoforme Störungen (SOMS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
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)
Change in saliva cortisol
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in saliva alpha amylase
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in mismatch negativity
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in loudness dependence auditory evoked potentials
Time frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Background: PubMed 25515221Gaudlitz K, Plag J, Dimeo F, Strohle A. Aerobic exercise training facilitates the effectiveness of cognitive behavioral therapy in panic disorder. Depress Anxiety. 2015 Mar;32(3):221-8. doi: 10.1002/da.22337. Epub 2014 Dec 17.
- Background: PubMed 16616936Ghisolfi ES, Heldt E, Zanardo AP, Strimitzer IM Jr, Prokopiuk AS, Becker J, Cordioli AV, Manfro GG, Lara DR. P50 sensory gating in panic disorder. J Psychiatr Res. 2006 Sep;40(6):535-40. doi: 10.1016/j.jpsychires.2006.02.006. Epub 2006 Apr 17.
- Background: PubMed 8383545Hegerl U, Juckel G. Intensity dependence of auditory evoked potentials as an indicator of central serotonergic neurotransmission: a new hypothesis. Biol Psychiatry. 1993 Feb 1;33(3):173-87. doi: 10.1016/0006-3223(93)90137-3.
- Background: PubMed 9172705Clark CR, McFarlane AC, Weber DL, Battersby M. Enlarged frontal P300 to stimulus change in panic disorder. Biol Psychiatry. 1996 May 15;39(10):845-56. doi: 10.1016/0006-3223(95)00288-x.
- Background: PubMed 7774770Naatanen R. The mismatch negativity: a powerful tool for cognitive neuroscience. Ear Hear. 1995 Feb;16(1):6-18.
- Background: PubMed 25085607Plag J, Gaudlitz K, Schumacher S, Dimeo F, Bobbert T, Kirschbaum C, Strohle A. Effect of combined cognitive-behavioural therapy and endurance training on cortisol and salivary alpha-amylase in panic disorder. J Psychiatr Res. 2014 Nov;58:12-9. doi: 10.1016/j.jpsychires.2014.07.008. Epub 2014 Jul 21.
- Background: PubMed 23481259Schumacher S, Kirschbaum C, Fydrich T, Strohle A. Is salivary alpha-amylase an indicator of autonomic nervous system dysregulations in mental disorders?--a review of preliminary findings and the interactions with cortisol. Psychoneuroendocrinology. 2013 Jun;38(6):729-43. doi: 10.1016/j.psyneuen.2013.02.003. Epub 2013 Mar 5.
- Background: PubMed 15705728Burgomaster KA, Hughes SC, Heigenhauser GJ, Bradwell SN, Gibala MJ. Six sessions of sprint interval training increases muscle oxidative potential and cycle endurance capacity in humans. J Appl Physiol (1985). 2005 Jun;98(6):1985-90. doi: 10.1152/japplphysiol.01095.2004. Epub 2005 Feb 10.
- Background: PubMed 2076086Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
- Background: PubMed 9648338Stober J, Bittencourt J. Weekly assessment of worry: an adaptation of the Penn State Worry Questionnaire for monitoring changes during treatment. Behav Res Ther. 1998 Jun;36(6):645-56. doi: 10.1016/s0005-7967(98)00031-x.
- Background: PubMed 2963053Maier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988 Jan-Feb;14(1):61-8. doi: 10.1016/0165-0327(88)90072-9.
- Background: PubMed 25119343Plag J, Schumacher S, Strohle A. [Generalized anxiety disorder]. Nervenarzt. 2014 Sep;85(9):1185-94. doi: 10.1007/s00115-014-4121-8. German.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Plag JP Plag, Dr. study chair
Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensive aerobe exercise and low-intensive aerobe exercise in people with Generalized Anxiety Disorder (GAD), run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662803, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.