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

August 7, 2026 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 was designed 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 originally aimed to recruit 240 participants (120 per group). A total of 135 participants were enrolled, of whom 129 participants completed baseline assessments and were randomized to either group-based GMT (GMT; n = 64) or wait-list control (WL; n = 65), all aged 18 to 65 years with a history of laboratory- or home-test confirmed, SARS-CoV-2 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. GMT was internet-delivered to groups of 4-7 participants in six weekly two-hour sessions. The primary outcome was 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 included 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 long-term effects of GMT at 2- and 4-year follow-up.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

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 Locations

  • Norway
      • Oslo, Norway
        • Lovisenberg Diaconal Hospital

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
  • 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
No Intervention: Wait list
Wait list control condition
Experimental: Goal Management Training (GMT)
Internet-delivered group-based GMT to groups of 4-7 participants in six two-hour sessions delivered weekly. 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

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
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
Insomnia Severity Index
Time Frame: Change from baseline up to 6 months
Self-report measure of insomnia. Range: 0-28. Higher score indicate more acute symptoms of insomnia
Change from baseline up to 6 months
The Behaviour regulation Index from Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Time Frame: Change from baseline to 6 months, 2 years, and 4 years
Self-report measure of daily life executive function (behaviour regulation). Range: 70-210. Higher score indicate greater executive dysfunction.
Change from baseline to 6 months, 2 years, and 4 years
Cambridge Neuropsychological Test Automated Battery (CANTAB), subtests: Spatial Working Memory, Rapid Visual Information Processing, One Touch Stockings of Cambridge
Time Frame: Change from baseline to 6 months, 2 years, and 4 years
Performance-based neurocognitive test battery
Change from baseline to 6 months, 2 years, and 4 years
The Hospital Anxiety and Depression Scale
Time Frame: Change from baseline to 6 months, 2 years, and 4 years
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 to 6 months, 2 years, and 4 years
The Generalized Self-Efficacy Scale
Time Frame: Change from baseline to 6 months, 2 years, and 4 years
Self-report measure of self-efficacy. Range:10-40. Higher score indicate higher self-efficacy.
Change from baseline to 6 months, 2 years, and 4 years
Fatigue Severity Scale
Time Frame: Change from baseline to 6 months, 2 years, and 4 years
Self-report measure of fatigue. 7 items. Range 7-49. Higher score indicate more fatigue.
Change from baseline to 6 months, 2 years, and 4 years
The Perceived Deficits Questionnaire
Time Frame: Change from baseline to 6 months, 2 years, and 4 years
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 to 6 months, 2 years, and 4 years
Everyday Memory Questionnaire
Time Frame: Change from baseline to 6 months, 2 years, and 4 years
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 to 6 months, 2 years, and 4 years
RAND 12-Item Health Survey (RAND-12)
Time Frame: Change from baseline to 6 months, 2 years, and 4 years
Self-report measure of quality of life. Range 0-10; a high score defines a more favorable health state.
Change from baseline to 6 months, 2 years, and 4 years
EuroQol five-dimension scale questionnaire (EQ-5D)
Time Frame: Change from baseline to 6 months, 2 years, and 4 years
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 to 6 months, 2 years, and 4 years
The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Time Frame: Change from baseline to 2 years and 4 years
Self-report measure of daily life executive function (metacognition). Range: 70-210. Higher score indicate greater executive dysfunction.
Change from baseline to 2 years and 4 years

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

Helpful Links

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 (Actual)

February 1, 2025

Study Completion (Estimated)

December 1, 2028

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)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

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

product manufactured in and exported from the U.S.

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.

Subscribe