Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05494424
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2022-08-09
Brief Title:
Cognitive Rehabilitation in Post-COVID-19 Condition
Sponsor:
Lovisenberg Diakonale Hospital
Organization:
Lovisenberg Diakonale Hospital
Study Overview
Official Title:
Cognitive Rehabilitation in Post-COVID-19 Condition A Study Protocol for a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAINCOVID
Brief Summary:
Post-COVID-19 condition is frequently comprised of persistent cognitive sequela including deficits in attention and executive functions EFs Goal Management Training GMT is a cognitive rehabilitation CR intervention for improving attention and EFs that has received empirical support in studies of other patient groups The present study aims to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after COVID-19 The study is a randomized controlled trial RCT comparing the efficacy of GMT to a wait list control condition WL for improving persistent cognitive sequela in post-COVID-19 condition The study aims to recruit 240 participants aged 18 to 65 years with a history of laboratory- or home-test confirmed SARS-CoV-2 infection 3 months since infection and perceived attentional and EF difficulties in daily life that have lasted for at least two months and that cannot be explained by an alternative diagnosis Participants will be randomized to either group-based GMT n 120 or WL n 120 GMT will be internet-delivered to groups of six participants in six two-hour sessions delivered weekly five weeks The primary outcome will be the Metacognition Index of the Behavior Rating Inventory of Executive Function - Adult Version a self-report measure assessing everyday EF difficulties at six months post-treatment Secondary outcomes include performance-based neurocognitive measures and rating scales of cognition emotional health quality of life and fatigue
Secondary aims include to explore to what extent potential early change predicts outcome and to examine what characterize those who profit from GMT in addition to describe the neurocognitive and emotional health in a Covid-19 sample The investigators will also examine potential effects of GMT at 2- and 5-year follow-up
Secondary aims include to explore to what extent potential early change predicts outcome and to examine what characterize those who profit from GMT in addition to describe the neurocognitive and emotional health in a Covid-19 sample The investigators will also examine potential effects of GMT at 2- and 5-year follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None