U08.9 U09.9 U10.9
Conditions
Interventions
Group 1: Patients with post-COVID syndrome
Experimental intervention: 4-6 sessions of neurofeedback (30-40 min) with stress test at 1st, 3rd and last time over 6 weeks, daily voice input and weekly q
Sponsors
Universitätsklinikum Heidelberg, Klinik für Allgemeine Innere Medizin und Psychosomatik (Innere II)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must have a current post-COVID diagnosis with fatigue and PEM symptoms
Exclusion criteria
Exclusion criteria: Patients who already suffered from previous illnesses that caused fatigue and other ongoing chronic diseases before the COVID infection were excluded from the patient groups. People who suffer from depressive and/or anxious symptoms in addition to fatigue are excluded from the patient groups. This is determined using cut-off scores in the PHQ-9 and GAD-7 (<10 each). In addition, participants who have already received neurofeedback training must be excluded, since previous experience would influence the result. As a further exclusion criterion, there must be no psychiatric diagnosis (diagnosis groups according to ICD-10: F10-F19 mental and behavioral disorders caused by psychotropic substances; F20-F29 schizophrenia, schizotype and delusional disorders; F30-F39 affective disorders; F40. phobic disorders; F41. Other anxiety disorders; F42.- Obsessive-compulsive disorder). An adjustment disorder (F43) is not an exclusion criterion. Prior to recruitment, participants will be excluded who are taking the following medications. These are: • Sympathomimetics (including oral or inhaled beta-2 mimetics) • Sympatholytics (including beta blockers) • Parasympathomimetics • Parasympatholytics • Sinus node inhibitors (including ivabradine) • Antiarrhythmics • Opioids • Glucocorticoids • Antidepressants • Hypnotics/sedatives • neuroleptics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of fatigue as measured with the fatigue severity scale (FSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Does neurofeedback training work for patients over 5 sessions? (effect) - At what point in time can an effect be observed? (onset) - Is the effect of neurofeedback training still recognizable 6 weeks after completing the study? (sustainability) - Which parameters of stress processing influence the effect of neurofeedback training? (moderators) - Do PESE (post-exertional symptom exacerbations) occur and under what conditions? (exploratory question) | — |
Countries
Germany
Outcome results
None listed