Cognitive Rehabilitation for People With Cognitive Covid19

Cognitive Impairment in Long Covid: PhEnotyping and RehabilitatiOn (CICERO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Long Covid19
• Intervention / Treatment: Behavioral: Cognitive rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged between 30 and 60 years

2. 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
3. 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:

1. Cognitive impairment prior to CV19 infection
2. Occurrence of acute neurological disorder, such as stroke or encephalitis, that could give rise to cognitive sequelae
3. People who are on any medications that are considered by the study investigators to have significant adverse effects on cognition
4. A pre-existing major psychiatric or medical disorder that is considered by the study investigators to have potential to affect cognition
5. High alcohol intake
6. Recreational drug use
7. Loss of mental capacity such that the affected individual is unable to give informed consent
8. 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.
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; cognitive rehabilitation programme. 1h session per week x 10 weeks	Behavioral: Cognitive rehabilitation; Set of restorative and compensatory strategies to rehabilitate cognitive function combined with emotional regulation techniques.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Goal-attainment	performance on goals selected by participants	measured at baseline, 3 and 6 months post-randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive function	set of tests to measure objective improvements in cognitive function	measured at baseline, 3 and 6 months post-randomisation
Change in quality of life (EQ-5D-5L)	Measure of quality of life	measured at baseline, 3 and 6 months post-randomisation
Change in Life Space Questionnaire	Measures the extent of mobility	measured at baseline, 3 and 6 months post-randomisation
Social Functioning (SF-DEM)	patient reported outcome measure to assess social functioning	measured at baseline, 3 and 6 months post-randomisation
Change in Instrumental Activities of Daily Living (IADL) Scale	assessment of independent living skills	measured at baseline, 3 and 6 months post-randomisation
Generalised Anxiety Disorder Assessment (GAD-7)	measures levels of anxiety	measured at baseline, 3 and 6 months post-randomisation
Change in Patient Health Questionnaire (PHQ-8)	measures depressive disorders	measured at baseline, 3 and 6 months post-randomisation
Change in Chalder Fatigue Scale	measures the severity of tiredness in fatiguing illnesses	measured at baseline, 3 and 6 months post-randomisation
Change in Pittsburgh Sleep Quality (PSQI)	slef reported questionnaire that assesses sleep quality	measured at baseline, 3 and 6 months post-randomisation
Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM).	measures presence and severity of post-exertional malaise	measured at baseline, 3 and 6 months post-randomisation
Change in Client Service Receipt Inventory (CSRI)	tool used to collect information on the whole range of services and supports study participants may use	measured at baseline, 3 and 6 months post-randomisation

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: University Hospital Southampton NHS Foundation Trust; Bangor University; St George's University Hospitals NHS Foundation Trust; University of Brighton; Greater Manchester Mental Health NHS Foundation Trust
• Investigators: Principal Investigator: Dennis Chan, Dr, University College, London

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Covid19; cognitive rehabilitation; brain fog
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: CICERO clinical trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No