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Long Covid19NCT05731570

Cognitive Rehabilitation for People With Cognitive Covid19

A study testing Cognitive rehabilitation in people with Long Covid19, run by University College, London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Long Covid19
What is being tested?
Cognitive rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited Kingdom
Study dates
14 Feb 2023to Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University College London

    London, WC1N 3BG

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Long Covid19
Being tested
Cognitive rehabilitation
Keywords
cognitive rehabilitation, brain fog, Covid19
Medical subject headings
Post-Acute COVID-19 Syndrome, Mental Fatigue, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive rehabilitationBehavioural

    Set of restorative and compensatory strategies to rehabilitate cognitive function combined with emotional regulation techniques.

Study groups in NCT05731570
Study groupRoleWhat they receive
InterventionExperimentalcognitive rehabilitation programme. 1h session per week x 10 weeks
Receives: Behavioral: Cognitive rehabilitation
ControlNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Goal-attainment

    performance on goals selected by participants

    Measured: measured at baseline, 3 and 6 months post-randomisation

Secondary outcomes (11)

  1. Change in cognitive function

    set of tests to measure objective improvements in cognitive function

    Measured: measured at baseline, 3 and 6 months post-randomisation

  2. Change in quality of life (EQ-5D-5L)

    Measure of quality of life

    Measured: measured at baseline, 3 and 6 months post-randomisation

  3. Change in Life Space Questionnaire

    Measures the extent of mobility

    Measured: measured at baseline, 3 and 6 months post-randomisation

  4. Social Functioning (SF-DEM)

    patient reported outcome measure to assess social functioning

    Measured: measured at baseline, 3 and 6 months post-randomisation

  5. Change in Instrumental Activities of Daily Living (IADL) Scale

    assessment of independent living skills

    Measured: measured at baseline, 3 and 6 months post-randomisation

  6. Generalised Anxiety Disorder Assessment (GAD-7)

    measures levels of anxiety

    Measured: measured at baseline, 3 and 6 months post-randomisation

  7. Change in Patient Health Questionnaire (PHQ-8)

    measures depressive disorders

    Measured: measured at baseline, 3 and 6 months post-randomisation

  8. Change in Chalder Fatigue Scale

    measures the severity of tiredness in fatiguing illnesses

    Measured: measured at baseline, 3 and 6 months post-randomisation

  9. Change in Pittsburgh Sleep Quality (PSQI)

    slef reported questionnaire that assesses sleep quality

    Measured: measured at baseline, 3 and 6 months post-randomisation

  10. Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM).

    measures presence and severity of post-exertional malaise

    Measured: measured at baseline, 3 and 6 months post-randomisation

  11. 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: measured at baseline, 3 and 6 months post-randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start14 Feb 2023
  3. Primary completionJul 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731570
Sponsor's protocol ID
CICERO clinical trial
Status last verified
Jun 2024
First submitted
9 Feb 2023
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vanova M, Patel AMR, Scott I, Gilpin G, Manning EN, Ash C, Wittenberg P, Lim J, Hoare Z, Evans R, Bray N, Kipps CM, Devine C, Ahmed S, Dunne R, Koniotes A, Warren C, Chan D, Suarez-Gonzalez A. Cognitive Rehabilitation and Functional Outcomes in Long COVID-Related Cognitive Impairment: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2620687. doi: 10.1001/jamanetworkopen.2026.20687.

    PubMed 42384384

  • Vanova M, Patel AMR, Scott I, Gilpin G, Manning EN, Ash C, Wittenberg P, Lim J, Hoare Z, Evans R, Bray N, Kipps CM, Devine C, Ahmed S, Dunne R, Koniotes A, Warren C, Chan D, Suarez-Gonzalez A. Telehealth-delivered cognitive rehabilitation for people with cognitive impairment as part of the post-COVID syndrome: protocol for a randomised controlled trial as part of the CICERO (Cognitive Impairment in Long COVID: Phenotyping and Rehabilitation) study. Trials. 2024 Oct 22;25(1):704. doi: 10.1186/s13063-024-08554-3.

    PubMed 39434179

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive rehabilitation in people with Long Covid19, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Goal-attainment (time frame: measured at baseline, 3 and 6 months post-randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05731570, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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