Cognitive Rehabilitation in Post-COVID-19 Condition (TRAINCOVID)

September 8, 2023 updated by: Lovisenberg Diakonale Hospital

Cognitive Rehabilitation in Post-COVID-19 Condition: A Study Protocol for a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Head of Research at Lovisenberg Hospital
  • Phone Number: (+47) 95033144
  • Email: anners.lerdal@lds.no

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • history of laboratory- or home-test confirmed, SARS-CoV-2 infection (> 3 months since infection)
  • perceived cognitive difficulties (attention, memory, EF) affecting everyday functioning that have lasted for at least two months and that cannot be explained by an alternative diagnosis
  • age between 18-65 years

Exclusion Criteria:

  • ongoing alcohol- or substance abuse, premorbid insult and/or comorbid neurological disease, severe neurocognitive problems interfering with the capacity to participate, sensory disorders biasing cognitive assessment, psychotic disorders, lack of proficiency in Norwegian, and being previously enrolled in a GMT trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Goal Management Training (GMT)
Internet-delivered group-based GMT to groups of six participants in six two-hour sessions delivered weekly (five weeks). Manualized intervention.
Behavioral: Goal Management Training (GMT)
Goal Management Training is a cognitive rehabilitation intervention that relies on metacognitive strategies to reengage top-down attention processes, in addition to teaching problem-solving techniques, attempting to address executive dysfunctions.
Other Names:
  • GMT
No Intervention: Wait list
Wait list control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Time Frame: Change from baseline up to 6 months
Self-report measure of daily life executive function (metacognition). Range:70-210. Higher score indicate greater executive dysfunction.
Change from baseline up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Behaviour regulation Index from Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Time Frame: Change from baseline up to 6 months
Self-report measure of daily life executive function (behaviour regulation). Range: 70-210. Higher score indicate greater executive dysfunction.
Change from baseline up to 6 months
Cambridge Neuropsychological Test Automated Battery (CANTAB), subtests: the Stop Signal Task, Spatial Working Memory, Intra-Extra Dimensional Set Shift and Rapid Visual Information Processing
Time Frame: Change from baseline up to 6 months
Performance-based neurocognitive test battery
Change from baseline up to 6 months
The Hospital Anxiety and Depression Scale
Time Frame: Change from baseline up to 6 months
Self-report measure of symptoms of anxiety and depression. The maximum score is 21 for depression and 21 for anxiety, range 0-21 on each scale. A higher score = more symptoms.
Change from baseline up to 6 months
The Generalized Self-Efficacy Scale
Time Frame: Change from baseline up to 6 months
Self-report measure of self-efficacy. Range:10-40. Higher score indicate higher self-efficacy.
Change from baseline up to 6 months
Fatigue Severity Scale
Time Frame: Change from baseline up to 6 months
Self-report measure of fatigue. 7 items. Range 7-49. Higher score indicate more fatigue.
Change from baseline up to 6 months
The Perceived Deficits Questionnaire
Time Frame: Change from baseline up to 6 months
Self-report measure of daily-life cognitive difficulties. The total score range from 0 to 80, with a higher score indicating greater perceived cognitive impairment.
Change from baseline up to 6 months
Everyday Memory Questionnaire
Time Frame: Change from baseline up to 6 months
Self-report measure of daily-life cognitive difficulties. The total score range from 0 to 52, with a higher score indicating greater perceived cognitive impairment.
Change from baseline up to 6 months
RAND 12-Item Health Survey (RAND-12)
Time Frame: Change from baseline up to 6 months
Self-report measure of quality of life. Range 0-10; a high score defines a more favorable health state.
Change from baseline up to 6 months
EuroQol five-dimension scale questionnaire (EQ-5D)
Time Frame: Change from baseline up to 6 months
Self-report measure of quality of life. The range of the EQ-5D index scores is 0 to 1 (1 indicates the best health state), but negative scores as low as-0.59 are possible for health states deemed to be worse than death.
Change from baseline up to 6 months
DUKE-UNC Functional Social Support Questionnaire (FSSQ)
Time Frame: Change from baseline up to 6 months
Self-report measure of social support. 8 items. The total score range from 8 to 40. Higher score indicates more social support.
Change from baseline up to 6 months
DePaul Symptom Questionnaire short version
Time Frame: Change from baseline up to 6 months
Self-report measure of fatigue symptoms. 14 items. The total score range from 0 to 56 for both frequency and severity for each item.
Change from baseline up to 6 months
The Resilience Scale for Adults
Time Frame: Change from baseline up to 6 months
Self-report measure of resilience. 33 items. The total score range from 33 to 165
Change from baseline up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lovisenberg Diakonale Hospital

Collaborators

University of Oslo
Oslo University Hospital
Icahn School of Medicine at Mount Sinai
University of Toronto
UiT The Arctic University of Norway

Investigators

  • Principal Investigator: Jan Stubberud, PhD, University of Oslo and Lovisenberg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Traincovid

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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