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NCT Number: NCT05494424

Cognitive Rehabilitation in Post-COVID-19 Condition

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lovisenberg Diaconal Hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Goal Management Training (GMT)

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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.

Sponsors and collaborators

Lead sponsor

Lovisenberg Diakonale Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TRAINCOVID

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Aug 10, 2022
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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