search
Back to results

Cognitive Rehabilitation for People With Cognitive Covid19

Primary Purpose

Long Covid19

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive rehabilitation
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long Covid19 focused on measuring cognitive rehabilitation, brain fog, Covid19

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged between 30 and 60 years Evidence of prior CV19 infection: either positive CV19 PCR or positive CV19 antibody test or acute symptoms consistent with the recognised core features of acute CV19 infection and post-acute symptoms consistent with the recognised core features of long Covid Cognitive impairment persisting more than three months after the acute CV19 infection, defined in terms of subjective reports of cognitive decline post-infection Exclusion Criteria: Cognitive impairment prior to CV19 infection Occurrence of acute neurological disorder, such as stroke or encephalitis, that could give rise to cognitive sequelae People who are on any medications that are considered by the study investigators to have significant adverse effects on cognition A pre-existing major psychiatric or medical disorder that is considered by the study investigators to have potential to affect cognition High alcohol intake Recreational drug use Loss of mental capacity such that the affected individual is unable to give informed consent Participants will not be eligible for Workstream 2 if they do not exhibit significant impairment on baseline cognitive assessments, as they will not gain from cognitive rehabilitation. Participants with pacemakers or other implanted devices, those with metal foreign bodies (e.g. shrapnel from war injuries) and those who have had certain types of surgery will be excluded from the MRI substudy. Although MRI is not known to affect the unborn child, we will also exclude subjects who may be pregnant just to be on the safe side.

Sites / Locations

  • University College LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

cognitive rehabilitation programme. 1h session per week x 10 weeks

The control group receives treatment as usual, this is, participants will carry on with the care they were receiving prior to entry in the study.

Outcomes

Primary Outcome Measures

Change in Goal-attainment
performance on goals selected by participants

Secondary Outcome Measures

Change in cognitive function
set of tests to measure objective improvements in cognitive function
Change in quality of life (EQ-5D-5L)
Measure of quality of life
Change in Life Space Questionnaire
Measures the extent of mobility
Social Functioning (SF-DEM)
patient reported outcome measure to assess social functioning
Change in Instrumental Activities of Daily Living (IADL) Scale
assessment of independent living skills
Generalised Anxiety Disorder Assessment (GAD-7)
measures levels of anxiety
Change in Patient Health Questionnaire (PHQ-8)
measures depressive disorders
Change in Chalder Fatigue Scale
measures the severity of tiredness in fatiguing illnesses
Change in Pittsburgh Sleep Quality (PSQI)
slef reported questionnaire that assesses sleep quality
Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM).
measures presence and severity of post-exertional malaise
Change in Client Service Receipt Inventory (CSRI)
tool used to collect information on the whole range of services and supports study participants may use

Full Information

First Posted
February 9, 2023
Last Updated
February 17, 2023
Sponsor
University College, London
Collaborators
Bangor University, St George's University Hospitals NHS Foundation Trust, University of Brighton, University Hospital Southampton NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT05731570
Brief Title
Cognitive Rehabilitation for People With Cognitive Covid19
Official Title
Cognitive Impairment in Long Covid: PhEnotyping and RehabilitatiOn (CICERO)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Bangor University, St George's University Hospitals NHS Foundation Trust, University of Brighton, University Hospital Southampton NHS Foundation Trust, Greater Manchester Mental Health NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cognitive impairment is increasingly recognised as a major component of long Covid, and is estimated to be present in 25-75% of affected individuals. This impairment impacts quality of life and the loss of functional ability has major consequences for affected people, their families and the wider economy given people's difficulty in returning to work. This study will focus on helping people recover from cognitive Covid. This will involve use of rehabilitation strategies aimed at improving function in those cognitive functions identified in Stage 1 as being most affected, and assessing the benefit of rehabilitation on quality of life and people's ability to return to everyday function. These strategies will be co-produced in collaboration with a group of people living with cognitive Covid. At the end of Stage 2 we will produce a freely available "Covid-19 Cognitive Recovery Guide" for affected people, their close contacts and clinicians. In conclusion, cognitive impairment is frequently observed in long Covid but at present little is understood about its nature, or how it can be treated. The sheer scale of the CV19 pandemic makes this a top priority unmet need for healthcare worldwide. The aim of this study is to meet this need and to deliver a treatment plan for affected people which will help them return to normal life and working ability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long Covid19
Keywords
cognitive rehabilitation, brain fog, Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
cognitive rehabilitation programme. 1h session per week x 10 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group receives treatment as usual, this is, participants will carry on with the care they were receiving prior to entry in the study.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive rehabilitation
Intervention Description
Set of restorative and compensatory strategies to rehabilitate cognitive function combined with emotional regulation techniques.
Primary Outcome Measure Information:
Title
Change in Goal-attainment
Description
performance on goals selected by participants
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Secondary Outcome Measure Information:
Title
Change in cognitive function
Description
set of tests to measure objective improvements in cognitive function
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Change in quality of life (EQ-5D-5L)
Description
Measure of quality of life
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Change in Life Space Questionnaire
Description
Measures the extent of mobility
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Social Functioning (SF-DEM)
Description
patient reported outcome measure to assess social functioning
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Change in Instrumental Activities of Daily Living (IADL) Scale
Description
assessment of independent living skills
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Generalised Anxiety Disorder Assessment (GAD-7)
Description
measures levels of anxiety
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Change in Patient Health Questionnaire (PHQ-8)
Description
measures depressive disorders
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Change in Chalder Fatigue Scale
Description
measures the severity of tiredness in fatiguing illnesses
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Change in Pittsburgh Sleep Quality (PSQI)
Description
slef reported questionnaire that assesses sleep quality
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM).
Description
measures presence and severity of post-exertional malaise
Time Frame
measured at baseline, 3 and 6 months post-randomisation
Title
Change in Client Service Receipt Inventory (CSRI)
Description
tool used to collect information on the whole range of services and supports study participants may use
Time Frame
measured at baseline, 3 and 6 months post-randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged between 30 and 60 years Evidence of prior CV19 infection: either positive CV19 PCR or positive CV19 antibody test or acute symptoms consistent with the recognised core features of acute CV19 infection and post-acute symptoms consistent with the recognised core features of long Covid Cognitive impairment persisting more than three months after the acute CV19 infection, defined in terms of subjective reports of cognitive decline post-infection Exclusion Criteria: Cognitive impairment prior to CV19 infection Occurrence of acute neurological disorder, such as stroke or encephalitis, that could give rise to cognitive sequelae People who are on any medications that are considered by the study investigators to have significant adverse effects on cognition A pre-existing major psychiatric or medical disorder that is considered by the study investigators to have potential to affect cognition High alcohol intake Recreational drug use Loss of mental capacity such that the affected individual is unable to give informed consent Participants will not be eligible for Workstream 2 if they do not exhibit significant impairment on baseline cognitive assessments, as they will not gain from cognitive rehabilitation. Participants with pacemakers or other implanted devices, those with metal foreign bodies (e.g. shrapnel from war injuries) and those who have had certain types of surgery will be excluded from the MRI substudy. Although MRI is not known to affect the unborn child, we will also exclude subjects who may be pregnant just to be on the safe side.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aida Suarez Gonzalez, Dr
Phone
00 44 020 34483655
Email
aida.gonzalez@ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Gina Gilpin
Email
gina.gilpin.19@ucl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Chan, Dr
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aida Suarez-Gonzalez, Dr
Email
aida.gonzalez@ucl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Rehabilitation for People With Cognitive Covid19

We'll reach out to this number within 24 hrs