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Trial - DRKS00028104


Column Value
Trial registration number DRKS00028104
Full text link
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Matthias Weisbrod

Contact
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

matthias.weisbrod@srh.de

Registration date
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2022-02-18

Recruitment status
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Long covid

Inclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

- 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

Exclusion criteria
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

- Minors- Legal age but not able to consent- lacking knowledge of the german language- intellectual impairment

Number of arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Abteilung für Psychiatrie und PsychotherapieSRH Klinikum Karlsbad-Langensteinbach

Inclusion age min
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Germany

Type of patients
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Patients recovered from covid

Severity scale
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

48

primary outcome
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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

Notes
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : March 11, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"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"}]