Trial registration number
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DRKS00028104 |
Full text link
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.drks.de/DRKS00028104
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First author
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Matthias Weisbrod
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Contact
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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matthias.weisbrod@srh.de
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Registration date
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-02-18
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Recruitment status
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Long covid
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Inclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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- Diagnosis: ICD-10 F06.8 Other specified mental disordes due to brain damage and dysfunction and to physicald disease U0.09 Post-COVID Zustand, not otherwise specified- Persisting complaints following the infection such as Fatigue, cognitive and emotional disturbancies and impairments in the psychosocial functional level- History of an infection with SARS-CoV-2 confirmed by a PCR-Test during the acute infection or a specific antibody test of antibodies against SARS-CoV-2 following the infection - Infection at least 3 month before inclusion in the study- Legal Age- Ability to consent
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Exclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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- Minors- Legal age but not able to consent- lacking knowledge of the german language- intellectual impairment
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Number of arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Abteilung für Psychiatrie und PsychotherapieSRH Klinikum Karlsbad-Langensteinbach
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Inclusion age min
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Germany
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Type of patients
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients recovered from covid
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Severity scale
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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48
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primary outcome
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Primary outcome is the performance in several neuropsychological assessments as well as the results of several self-rating questionaires. Assessments will take place before and after the intervention and the controll interval; respectively.The neuropsychological tests comprise:- testset COGBAT from Vienna Testing System- California Verbal Learning and Memory Test- Regensburger Wortflüssigkeitstest- Mosaiktest from the WAIS-IVThe questionaires comprise:- Fatigue Severity Scale- Fatigue Skala für Motorik und Kognition- Brief Symptom Checklist- Beck Depression Inventar II- Marburger Kompetenzskala- Montgomery Asberg Depression Rating Scale
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Notes
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 2383, "treatment_name": "Group-based therapy", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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