Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-05-01
Study Completion Date
2025-01-21
Brief Summary
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The investigators are comparing two different methods for helping adults with Long Coronavirus (COVID) also known as Post-Coronavirus Syndrome or Post-Coronavirus Condition manage everyday cognitive challenges. Cognitive rehabilitation is a type of therapy that helps people who have challenges with everyday thinking because of a brain injury. One of the investigators on this project along with colleagues in the United States (US) have developed a streamlined version of cognitive rehabilitation therapy for mild traumatic brain injury (mTBI) that can be completed in person or virtually and takes place over a 3-week period. The therapy was originally designed for adults with mTBI. The investigators want to know if it can also be used to treat people with cognitive complaints from Long COVID. The investigators will provide education materials only to one group and individual cognitive rehabilitation delivered by a trained Speech Language Pathologist (SLP) or Occupational Therapist (OT) to the other group. The investigators want to find out whether the individual therapy is as feasible and accessible than the usual educational material. What the investigators learn in this study may help treat day-to-day thinking challenges in Long COVID.
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Detailed Description
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Cognitive complaints are one of the most common, pervasive, and debilitating outcomes for adults with Long COVID. In a study of 3762 adults from 56 countries who were 7 months post-diagnosis of severe acute respiratory syndrome coronavirus-2 (SARS Coronavirus 2, referred to here as COVID) 85% reported cognitive problems, including brain fog, word-finding problems, difficulty communicating their thoughts, and a reduced ability to solve serious problems. In the Great British Intelligence Test, an online study of 81,337 individuals the subgroup of 12,689 who reported having had COVID had significantly lower cognitive test scores than those who had not, providing objective support for the symptoms that adults with Long COVID are reporting. These persistent cognitive symptoms, which the investigators refer to as Post-COVID Cognitive Symptoms (PCCS), do not appear to spontaneously resolve, with many patients in Canada and worldwide reporting cognitive impairments more than 1 year after infection. PCCS can have severe effects on usual functioning, particularly given that most survivors are working age. Two large studies estimated that at 7-9 months post-infection, between 40-75% of adults either could not work at all or were working fewer hours than they did pre-COVID. Although emerging data indicate that PCCS may be less common after infection with the Omicron variant, there continues to be concern about future "super-variants" that may have more virulent effects. Even if infection rates stabilize, i.e., COVID becomes endemic, the disease does not become harmless.
Usual care for those with PCCS is, at best, providing information about how to manage symptoms (e.g., this handout from the Public Health Authority of British Columbia). The literature on treatment of cognitive problems in other patient groups, however, shows that providing general information alone does not "fix" cognitive impairments. To improve cognitive function in everyday life, intervention must be individualized and provide opportunities for high-dose practice of target behaviours. The investigators do not, however, have interventions like this with demonstrated effectiveness for PCCS. The literature related to cognitive rehabilitation after COVID includes three types of papers: 1) studies of COVID effects on people who had cognitive diagnoses pre-COVID (e.g., how lack of services has affected patients with Alzheimer's Disease) 2) a small number of case reports of rehabilitation for COVID patients, in which cognitive rehabilitation is mentioned in general terms (e.g., patient received "skill training for basic activities of living" and "evaluation of adaptive devices", and 3) urgent calls for cognitive rehabilitation of adults with PCCS (e.g., 13-15). To the investigators knowledge, there are no published controlled studies of cognitive rehabilitation methods for adults with PCCS. One of the investigators recently completed a pilot pre-post study with 34 adults with Long COVID to examine if physical therapy for physical symptoms and occupational therapy for cognitive symptoms was safe and feasible (protocol completed, under analysis). The cognitive intervention was 6 hours of combined individual and group cognitive rehabilitation over 12 weeks, including education about managing cognitive challenges. The pilot data showed a reduction in intensity and frequency of cognitive symptoms, but no effect on everyday functioning. The study investigators concluded that to improve everyday function, therapy must be targeted at individual complaints, and it is this type of intervention that the investigators propose for a randomized control trial (RCT).
A recent paper in Science 16 called for cognitive rehabilitation to be part of the health system response to Long COVID, but rehabilitation was not included in the category of research needs - i.e., the paper implied that investigators already know how to treat patients with PCCS, and that investigators just need to increase access to therapy. However, it is unclear if standard cognitive rehabilitation methods used for other patient groups are effective for people with PCCS. One source of guidance for PCCS rehabilitation methods is the literature on cognitive rehabilitation for adults with traumatic brain injury (TBI), especially patients with mild TBI (aka concussion). Adults with mild TBI (mTBI) have symptoms that are commonly reported by adults with PCCS, such as word-finding problems, slow thinking, "brain fog", trouble following instructions, forgetting medications, difficulty in conversations, complaints about mental fatigue, and difficulty making decisions. There also is anecdotal evidence from clinicians who have overseen treatment of more than 3400 adults with Long COVID - that PCCS characteristics are very similar to patients with mild TBI. COVID and TBI share pathophysiological features such as inflammation, hypoxia, microvascular lesions and disruption of the blood-brain barrier, cortical thinning, and diffuse white-matter damage, particularly in anterior cortical regions. Best practices in cognitive rehabilitation also should be similar in both groups: treatments must be tailored to the patients needs, focused on solving everyday thinking challenges rather than 'fixing' deficits, and given in a relatively high dose.
In summary, PCCS is prevalent, debilitating, and persistent, and there is a lack of evidence-based methods to treat adults with these problems. TBI and COVID share pathophysiological features, survivors report similar cognitive symptoms, and best practices apply to both populations, thus the investigators predict that cognitive rehabilitation methods developed for adults with mTBI will also be effective for adults with PCCS.
Study design will follow recommendations in the CONSORT extension for randomized pilot and feasibility trials, so that data from the Vanguard study can be used in the main trial analysis. Results of the main study will significantly advance the investigators understanding of health consequences of COVID-19, delivery of health care, and health outcomes for adults with Long COVID. It is interdisciplinary research by a Canadian-led research team representing speech-language pathology, occupational therapy, physiotherapy, healthcare administration, and stakeholders with lived experience; and includes US collaborators representing the largest national company providing a cognitive rehabilitation program developed specifically for adults with Long COVID. The investigators collaboration with US partners is a step toward globalization of the rehabilitation methods.
The investigators propose to complete a Vanguard two-arm RCT of STAR-C3 with 100 adults randomized to either Therapy (n=50) or Education (n=50) groups. The study aims to demonstrate the acceptability, appropriateness, and feasibility of STAR-C3 as judged by clinicians and participants with PCCS. Therapy will be delivered by an Occupational Therapist (OT) or Speech-Language Pathologist (SLP).
Usual care for those with PCCS is, at best, providing information about how to manage symptoms (e.g., this handout from the Public Health Authority of British Columbia). The literature on treatment of cognitive problems in other patient groups, however, shows that providing general information alone does not "fix" cognitive impairments. To improve cognitive function in everyday life, intervention must be individualized and provide opportunities for high-dose practice of target behaviours. The investigators do not, however, have interventions like this with demonstrated effectiveness for PCCS. The literature related to cognitive rehabilitation after COVID includes three types of papers: 1) studies of COVID effects on people who had cognitive diagnoses pre-COVID (e.g., how lack of services has affected patients with Alzheimer's Disease) 2) a small number of case reports of rehabilitation for COVID patients, in which cognitive rehabilitation is mentioned in general terms (e.g., patient received "skill training for basic activities of living" and "evaluation of adaptive devices", and 3) urgent calls for cognitive rehabilitation of adults with PCCS (e.g., 13-15). To the investigators knowledge, there are no published controlled studies of cognitive rehabilitation methods for adults with PCCS. One of the investigators recently completed a pilot pre-post study with 34 adults with Long COVID to examine if physical therapy for physical symptoms and occupational therapy for cognitive symptoms was safe and feasible (protocol completed, under analysis). The cognitive intervention was 6 hours of combined individual and group cognitive rehabilitation over 12 weeks, including education about managing cognitive challenges. The pilot data showed a reduction in intensity and frequency of cognitive symptoms, but no effect on everyday functioning. The study investigators concluded that to improve everyday function, therapy must be targeted at individual complaints, and it is this type of intervention that the investigators propose for a randomized control trial (RCT).
A recent paper in Science 16 called for cognitive rehabilitation to be part of the health system response to Long COVID, but rehabilitation was not included in the category of research needs - i.e., the paper implied that investigators already know how to treat patients with PCCS, and that investigators just need to increase access to therapy. However, it is unclear if standard cognitive rehabilitation methods used for other patient groups are effective for people with PCCS. One source of guidance for PCCS rehabilitation methods is the literature on cognitive rehabilitation for adults with traumatic brain injury (TBI), especially patients with mild TBI (aka concussion). Adults with mild TBI (mTBI) have symptoms that are commonly reported by adults with PCCS, such as word-finding problems, slow thinking, "brain fog", trouble following instructions, forgetting medications, difficulty in conversations, complaints about mental fatigue, and difficulty making decisions. There also is anecdotal evidence from clinicians who have overseen treatment of more than 3400 adults with Long COVID - that PCCS characteristics are very similar to patients with mild TBI. COVID and TBI share pathophysiological features such as inflammation, hypoxia, microvascular lesions and disruption of the blood-brain barrier, cortical thinning, and diffuse white-matter damage, particularly in anterior cortical regions. Best practices in cognitive rehabilitation also should be similar in both groups: treatments must be tailored to the patients needs, focused on solving everyday thinking challenges rather than 'fixing' deficits, and given in a relatively high dose.
In summary, PCCS is prevalent, debilitating, and persistent, and there is a lack of evidence-based methods to treat adults with these problems. TBI and COVID share pathophysiological features, survivors report similar cognitive symptoms, and best practices apply to both populations, thus the investigators predict that cognitive rehabilitation methods developed for adults with mTBI will also be effective for adults with PCCS.
Study design will follow recommendations in the CONSORT extension for randomized pilot and feasibility trials, so that data from the Vanguard study can be used in the main trial analysis. Results of the main study will significantly advance the investigators understanding of health consequences of COVID-19, delivery of health care, and health outcomes for adults with Long COVID. It is interdisciplinary research by a Canadian-led research team representing speech-language pathology, occupational therapy, physiotherapy, healthcare administration, and stakeholders with lived experience; and includes US collaborators representing the largest national company providing a cognitive rehabilitation program developed specifically for adults with Long COVID. The investigators collaboration with US partners is a step toward globalization of the rehabilitation methods.
The investigators propose to complete a Vanguard two-arm RCT of STAR-C3 with 100 adults randomized to either Therapy (n=50) or Education (n=50) groups. The study aims to demonstrate the acceptability, appropriateness, and feasibility of STAR-C3 as judged by clinicians and participants with PCCS. Therapy will be delivered by an Occupational Therapist (OT) or Speech-Language Pathologist (SLP).
Conditions
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Long COVID
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Participants will be randomized to either the Therapy (n=50) or Education Group (n=50). At the conclusion of therapy (for the Therapy Group) or after three weeks (for the Education Group), participants will be re-administered the outcome measures. The outcome measures using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) will then be compared during data analysis between the two groups.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Assessor will be blinded to randomization
Study Groups
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Therapy Group
The Therapy Group will receive 6-10 individual sessions of 30-60 minutes each, delivered by a trained Occupational Therapist or Speech-Language Pathologist. The therapy will be delivered over a 4-week timeframe, with the total number of sessions per participant depending on the number of sessions needed to achieve their treatment targets. Each participant in the Therapy Group will identify three cognitive targets for treatment. Progress in reaching those targets will be documented using Goal Attainment Scaling (GAS)
Group Type
EXPERIMENTAL
Cognitive Rehabilitation
Intervention Type
BEHAVIORAL
A strategy-focused intervention aimed at improving everyday cognitive function, structured to maximize treatment dose over a short time period. The shorter time period of the treatment therapy is relative to the one and only current randomized controlled trial of cognitive rehabilitation for military mTBI, the Study of Cognitive Rehabilitation Effectiveness (SCORE).
Educational Group
The Education group will receive information about self-management of cognitive symptoms at the time of randomization, a common alternative for adults with Long COVID cognitive symptoms who do not receive Individual Therapy.
Group Type
ACTIVE_COMPARATOR
Education
Intervention Type
OTHER
The Education group will receive information about self-management of cognitive symptoms at the time of randomization, a common alternative for adults with Long COVID cognitive symptoms who do not receive Individual Therapy.
Interventions
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Cognitive Rehabilitation
A strategy-focused intervention aimed at improving everyday cognitive function, structured to maximize treatment dose over a short time period. The shorter time period of the treatment therapy is relative to the one and only current randomized controlled trial of cognitive rehabilitation for military mTBI, the Study of Cognitive Rehabilitation Effectiveness (SCORE).
Intervention Type
BEHAVIORAL
Education
The Education group will receive information about self-management of cognitive symptoms at the time of randomization, a common alternative for adults with Long COVID cognitive symptoms who do not receive Individual Therapy.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Is a community-dwelling adults
* Is age 18 years or older
* Self-identifies as a fluent English speaker
* Have a history of COVID symptoms as listed on the Government of Canada COVID information website, a positive antigen or polymerase chain reaction (PCR) test, or both
* Have cognitive symptoms that have persisted a minimum of 12 weeks after contracting COVID
* Have cognitive symptoms attributable to COVID and not to other intervening diagnoses associated with cognitive dysfunction (e.g., psychosis, concussion), or medications with negative effects on cognitive function
* Have no previous history of a diagnosis of a neurological disorder affecting thinking (e.g., dementia)
* Are able to participate in 3 one-hour sessions per week for 4-6 weeks
* Are not in active behavioural treatment for a substance-use or mental-health disorder, or in cognitive rehabilitation provided by a registered health professional (e.g., speech-language pathologist or occupational therapist)
* Can access an electronic device with internet access and capability for Zoom videoconferencing
* Is age 18 years or older
* Self-identifies as a fluent English speaker
* Have a history of COVID symptoms as listed on the Government of Canada COVID information website, a positive antigen or polymerase chain reaction (PCR) test, or both
* Have cognitive symptoms that have persisted a minimum of 12 weeks after contracting COVID
* Have cognitive symptoms attributable to COVID and not to other intervening diagnoses associated with cognitive dysfunction (e.g., psychosis, concussion), or medications with negative effects on cognitive function
* Have no previous history of a diagnosis of a neurological disorder affecting thinking (e.g., dementia)
* Are able to participate in 3 one-hour sessions per week for 4-6 weeks
* Are not in active behavioural treatment for a substance-use or mental-health disorder, or in cognitive rehabilitation provided by a registered health professional (e.g., speech-language pathologist or occupational therapist)
* Can access an electronic device with internet access and capability for Zoom videoconferencing
Exclusion Criteria
* A score of less than 20 on the Montreal Cognitive Assessment (MoCA), which indicates a risk for dementia.
* Cannot identify at least 3 problems on the Common Cognitive Complaints after Concussion Questionnaire (C4), as there would be insufficient areas for intervention.
* Cannot identify at least 3 problems on the Common Cognitive Complaints after Concussion Questionnaire (C4), as there would be insufficient areas for intervention.
Minimum Eligible Age
18 Years
Maximum Eligible Age
100 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Sponsor Role
collaborator
McMaster University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jackie Bosch, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University School of Rehabilitation Science
Lyn Turkstra, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University School of Rehabilitation Science
Locations
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McMaster University
Hamilton, Ontario, Canada
Site Status
Countries
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Canada
References
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Landivar LC, Ruppanner L, Scarborough WJ, Collins C. Early Signs Indicate That COVID-19 Is Exacerbating Gender Inequality in the Labor Force. Socius. 2020 Aug 3;6:2378023120947997. doi: 10.1177/2378023120947997. eCollection 2020.
Reference Type
BACKGROUND
Bowleg L, Landers S. The Need for COVID-19 LGBTQ-Specific Data. Am J Public Health. 2021 Sep;111(9):1604-1605. doi: 10.2105/AJPH.2021.306463. Epub 2021 Aug 26. No abstract available.
Reference Type
BACKGROUND
Martin S, Mooruth D, Guerdoux-Ninot E, Mazzocco C, Brouillet D, Taconnat L, Trouillet R. Demographic Characteristics, Motivation and Perception of Change as Determinants of Memory Compensation Self-Reports After Acquired Brain Injury. Front Psychol. 2021 Jul 14;12:607035. doi: 10.3389/fpsyg.2021.607035. eCollection 2021.
Reference Type
BACKGROUND
Related Links
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https://imgix.cosmicjs.com/d8d3d3b0-c936-11eb-ba89-e7f98c8c358b-FINAL---Report-on-Long-Covid-Impact-Survey---June-8-2021.pdf
Viral Neuro Exploration (VINEx), COVID Long Haulers Support Group Canada, Neurological Health Charities Canada. Report on Long COVID Impact Survey. 2021
https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/prevalenceofongoingsymptomsfollowingcoronaviruscovid19infectionintheuk/5august2021
Office for National Statistics. Prevalence of ongoing symptoms following coronavirus (COVID-19) infection in the United Kingdom
https://www.nationalgeographic.com/science/article/how-does-covid-19-affect-the-brain-a-troubling-picture-emerges
How does COVID-19 affect the brain? A troubling picture emerges.
Other Identifiers
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15621
Identifier Type: -
Identifier Source: org_study_id
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