COVID-19TRAINCOVIDNCT05494424
Cognitive Rehabilitation in Post-COVID-19 Condition
A study testing Goal Management Training (GMT) in people with COVID-19, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Goal Management Training (GMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteNorway
- Study dates
- 8 Sep 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- Goal Management Training (GMT)
- Keywords
- Rehabilitation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Management Training (GMT)Behavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Goal Management Training (GMT) | Experimental | Internet-delivered group-based GMT to groups of 4-7 participants in six two-hour sessions delivered weekly. Manualized intervention. Receives: Behavioral: Goal Management Training (GMT) |
| Wait list | No intervention | Wait list control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Self-report measure of daily life executive function (metacognition). Range:70-210. Higher score indicate greater executive dysfunction.
Measured: Change from baseline up to 6 months
Secondary outcomes (12)
The Behaviour regulation Index from Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Self-report measure of daily life executive function (behaviour regulation). Range: 70-210. Higher score indicate greater executive dysfunction.
Measured: 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
Performance-based neurocognitive test battery
Measured: Change from baseline to 6 months, 2 years, and 4 years
The Hospital Anxiety and Depression Scale
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.
Measured: Change from baseline to 6 months, 2 years, and 4 years
The Generalized Self-Efficacy Scale
Self-report measure of self-efficacy. Range:10-40. Higher score indicate higher self-efficacy.
Measured: Change from baseline to 6 months, 2 years, and 4 years
Fatigue Severity Scale
Self-report measure of fatigue. 7 items. Range 7-49. Higher score indicate more fatigue.
Measured: Change from baseline to 6 months, 2 years, and 4 years
The Perceived Deficits Questionnaire
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.
Measured: Change from baseline to 6 months, 2 years, and 4 years
Everyday Memory Questionnaire
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.
Measured: Change from baseline to 6 months, 2 years, and 4 years
RAND 12-Item Health Survey (RAND-12)
Self-report measure of quality of life. Range 0-10; a high score defines a more favorable health state.
Measured: Change from baseline to 6 months, 2 years, and 4 years
EuroQol five-dimension scale questionnaire (EQ-5D)
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.
Measured: Change from baseline to 6 months, 2 years, and 4 years
DePaul Symptom Questionnaire short version
Self-report measure of fatigue symptoms. 14 items. The total score range from 0 to 56 for both frequency and severity for each item.
Measured: Change from baseline up to 6 months
Insomnia Severity Index
Self-report measure of insomnia. Range: 0-28. Higher score indicate more acute symptoms of insomnia
Measured: Change from baseline up to 6 months
The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Self-report measure of daily life executive function (metacognition). Range: 70-210. Higher score indicate greater executive dysfunction.
Measured: Change from baseline to 2 years and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start8 Sep 2023
- Primary completion1 Feb 2025
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Icahn School of Medicine at Mount Sinai, University of Toronto, UiT The Arctic University of Norway, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Jan Stubberud, PhD, Principal investigator, University of Oslo and Lovisenberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494424
- Sponsor's protocol ID
- Traincovid
- Acronym
- TRAINCOVID
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hagen BI, Lerdal A, Soraas A, Landro NI, Bo R, Smastuen MC, Becker J, Stubberud J. Cognitive rehabilitation in post-COVID-19 condition: A study protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Nov;122:106955. doi: 10.1016/j.cct.2022.106955. Epub 2022 Oct 5.
PubMed 36208718
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation in Post-COVID-19 Condition: A Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05494424
- Acronym / sponsor ID
- TRAINCOVID / Traincovid
- Conditions
- COVID-19
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Icahn School of Medicine at Mount Sinai, University of Toronto, UiT The Arctic University of Norway, Oslo University Hospital
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Management Training (GMT) | Experimental | Behavioral: Goal Management Training (GMT)Internet-delivered group-based GMT to groups of 4-7 participants in six two-hour sessions delivered weekly. Manualized intervention. |
| Wait list | No intervention | –Wait list control condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal Management Training (GMT)Also: GMTGoal 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. | Behavioural | Goal Management Training (GMT) |
Primary outcome
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.
12 secondary outcomes
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
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
The Hospital Anxiety and Depression Scale
Time frame: 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
Fatigue Severity Scale
Time frame: 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
Everyday Memory Questionnaire
Time frame: 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
EuroQol five-dimension scale questionnaire (EQ-5D)
Time frame: Change from baseline to 6 months, 2 years, and 4 years
DePaul Symptom Questionnaire short version
Time frame: Change from baseline up to 6 months
Insomnia Severity Index
Time frame: Change from baseline up to 6 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Derived from this study: PubMed 36208718Hagen BI, Lerdal A, Soraas A, Landro NI, Bo R, Smastuen MC, Becker J, Stubberud J. Cognitive rehabilitation in post-COVID-19 condition: A study protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Nov;122:106955. doi: 10.1016/j.cct.2022.106955. Epub 2022 Oct 5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Stubberud, PhD principal investigator
University of Oslo and Lovisenberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Management Training (GMT) in people with COVID-19, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) (time frame: Change from baseline up to 6 months). 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 NCT05494424, which also lists 1 linked publication.
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 11 Aug 2026.