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Trial - NCT05167266


Column Value
Trial registration number NCT05167266
Full text link
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05167266

First author
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Carmen Cabello, MD

Contact
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

C.Cabello@uliege.be

Registration date
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

2021-12-22

Recruitment status
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria: subjects able to understand the information and consent forms; medically stable and at least 3 months after positive pcr for covid-19; self-reported sufficiently good physical condition to attend the appointment; no major hearing or vision disorders; cognitive complaints that place the person in the top 20% of dissatisfied functioning on the brief or mmq questionnaires; poor objective performance supported by a score below the 20th percentile on one task of the cognitive battery.

Exclusion criteria
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

any chronic or remote neurological disorder (i.e. stroke, head trauma, epilepsy, tumor); cognitive impairment (minor or major neurocognitive disorder; intellectual disability) preexisting to the covid-19 episode; acute brain injury or acute encephalopathy from another aetiology than covid (e.g., sepsis, liver or renal failure, alcohol or drug withdrawal, drug toxicity); documented preexisting history of psychiatric illness, including substance abuse; open-heart cardiac surgery or cardiac arrest during the last 6 months; current hospitalization; current revalidation care with cognitive treatment

Number of arms
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

University of Liege

Inclusion age min
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

70

Countries
Last imported at : June 3, 2022, 2 p.m.
Source : ClinicalTrials.gov

Belgium

Type of patients
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

130

primary outcome
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Comparison of change in subjective cognitive difficulties between the two intervention arms

Notes
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Dec. 30, 2021, 4:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Cognitive psychoeducation", "treatment_id": 2348, "treatment_name": "Psychoeducation", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "Affective psychoeducation", "treatment_id": 2348, "treatment_name": "Psychoeducation", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}]