Cognitive Rehabilitation for People With Cognitive Covid19

Not Applicable

Active, not recruiting

• Conditions: Long Covid19
• Interventions: Behavioral: Cognitive rehabilitation

• Registration Number: NCT05731570
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study Start: 2023-02-14
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-16
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-07
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Cognitive rehabilitation	cognitive rehabilitation programme. 1h session per week x 10 weeks

Primary Outcome Measures

Name	Time	Method
Change in Goal-attainment	measured at baseline, 3 and 6 months post-randomisation	performance on goals selected by participants

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University College London; 🇬🇧 London, United Kingdom