Cognitive Rehabilitation for Post-COVID Syndrome

Overseen By Juliana H Earwood, OTD, OTR/L

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Severe neurological, psychiatric, dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 10 weeks

65 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment CO-OP Procedures for cognitive rehabilitation in post-COVID syndrome?

Cognitive remediation therapy, which is similar to CO-OP Procedures, has shown effectiveness in improving cognitive functions like verbal fluency and executive functions in COVID-19 survivors, leading to better quality of life. This suggests that CO-OP Procedures might also help improve cognitive impairments in post-COVID syndrome. ^{1 2 3 4 5}

Is cognitive rehabilitation for post-COVID syndrome safe for humans?

The studies reviewed do not provide specific safety data for cognitive rehabilitation treatments like CO-OP Procedures, but they focus on the feasibility and potential benefits of such interventions for cognitive dysfunction after COVID-19. Generally, cognitive rehabilitation is considered safe, as it involves non-invasive techniques to improve mental functions. ^{1 6 7 8 9}

How is the CO-OP treatment different from other treatments for post-COVID syndrome?

The CO-OP treatment is unique because it focuses on teaching patients problem-solving strategies to help them achieve meaningful daily activities, giving them more control over their treatment goals. This approach is different from traditional treatments that often focus on reducing specific impairments rather than enhancing overall functional skills. ^{10 11 12 13 14}

What is the purpose of this trial?

The first aim of this study is to determine the feasibility of delivering CO-OP remotely to individuals experiencing cognitive impairments that limit everyday activities in post-COVID-19 syndrome (PCS). The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of individuals with PCS. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to an inactive control group, on activity performance, subjective and objective cognition, and quality of life in a sample of individuals who self-report PCS and cognitive impairment.

Research Team

Anna E Boone, PhD, OTR/L

Principal Investigator

University of Missouri Occupational Therapy

Eligibility Criteria

This trial is for individuals who have had COVID-19 and are struggling with cognitive issues at least 6 weeks after infection. Participants should be able to set personal goals, speak English fluently, give informed consent electronically, and have a past diagnosis of COVID-19. People with severe depression, untreated sleep apnea, prior cancer treatment, serious neurological or psychiatric conditions, or signs of dementia are not eligible.

Inclusion Criteria

I can give my consent electronically after understanding the study.

I have set personal activity goals with the COPM.

You have been diagnosed with COVID-19 before.

Exclusion Criteria

I have been diagnosed with a severe neurological or psychiatric condition.

I have had treatment for cancer before.

I have been diagnosed with dementia based on my MoCA score.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CO-OP intervention remotely via Zoom, with one session per week over the course of 10 weeks

10 weeks

10 sessions (remote)

Control

Inactive control group receives one session per week over the course of 10 weeks, delivered remotely via Zoom

10 weeks

10 sessions (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments conducted at the end of the study

2 weeks

Treatment Details

Interventions

• CO-OP Procedures
• Inactive Control Group

Trial Overview The study tests if CO-OP (Cognitive Orientation to daily Occupational Performance) delivered remotely can help improve everyday activity performance, cognition and quality of life in people with Post-COVID Syndrome compared to an inactive control group.

Participant Groups

Group I: Inactive Control Group Experimental Treatment 1 Intervention

Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.

Group II: Cognitive Orientation to daily Occupational Performance (CO-OP) Experimental Treatment 1 Intervention

Each CO-OP session will last 45 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A neuropsychological rehabilitation program for post-COVID-19 syndrome significantly improved cognitive functions such as working memory and verbal fluency in 123 patients, with 74% experiencing cognitive impairment before treatment.

Despite these improvements, many patients (44.9%) were still unable to return to their pre-COVID-19 work activities six months after treatment, indicating that full recovery of functional levels may not be achieved for all.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neuropsychological rehabilitation for post-COVID-19 syndrome: Results of a clinical program and six-month follow up.] García-Molina, A., García-Carmona, S., Espiña-Bou, M., et al.[2023]

This study evaluates a comprehensive treatment program for post-acute COVID-19 syndrome (PACS) involving online screening and personalized support, aiming to improve diagnosis and recovery for patients.

Participants will be divided into groups receiving different levels of assessment and digital interventions, with the primary focus on symptom reduction and return to work, making it one of the first large-scale efforts to address PACS effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening and assessment for post-acute COVID-19 syndrome (PACS), guidance by personal pilots and support with individual digital trainings within intersectoral care: a study protocol of a randomized controlled trial. Dahmen, A., Keller, FM., Derksen, C., et al.[2022]

A cognitive remediation therapy (CRT) program significantly improved global cognitive functioning in 15 COVID-19 survivors over two months, compared to a matched untreated group of 30 patients, indicating its efficacy in addressing cognitive impairments post-COVID-19.

Improvements in specific cognitive areas, such as verbal fluency and executive functions, were linked to better quality of life, suggesting that CRT not only enhances cognitive abilities but also positively impacts overall well-being for COVID-19 survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation therapy for post-acute persistent cognitive deficits in COVID-19 survivors: A proof-of-concept study. Palladini, M., Bravi, B., Colombo, F., et al.[2023]

COVID-19 survivors are experiencing cognitive problems, often referred to as 'brain fog', which can significantly impact their daily activities and ability to return to work.

There is a need for further research into the nature and prevalence of these cognitive issues, as well as the potential application of brain injury recovery treatments to help improve cognitive function in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proposal to apply brain injury recovery treatments for cognitive impairment in COVID-19 survivors. Nouraeinejad, A.[2022]

A systematic review of 3596 Cochrane Systematic Reviews identified 17 reviews on cognitive impairment and 37 on anxiety and depression, suggesting various rehabilitation interventions could be beneficial for post COVID-19 condition (PCC) symptoms.

Interventions such as exercise training, cognitive training, and specific therapies (like acupuncture and yoga) showed varying degrees of effectiveness (from very low to moderate quality evidence) for improving cognitive and emotional symptoms, providing a foundation for future clinical practice and research recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive impairment, anxiety and depression: a map of Cochrane evidence relevant to rehabilitation for people with post COVID-19 condition. Cordani, C., Young, VM., Arienti, C., et al.[2023]

A pilot study involving 73 adults with cognitive dysfunction post-COVID-19 showed that an 8-week personalized computerized cognitive training (CCT) significantly improved cognitive function across multiple domains, including attention, memory, and reasoning.

Participants reported higher cognitive scores after the training compared to their baseline assessments, indicating that self-administered CCT could be an effective intervention for alleviating cognitive issues in individuals suffering from post-acute sequelae of COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Computerized Training for Cognitive Dysfunction after COVID-19: A Before-and-After Feasibility Pilot Study. Duñabeitia, JA., Mera, F., Baro, Ó., et al.[2023]

A neuropsychological rehabilitation program for post-COVID-19 syndrome significantly improved cognitive functions such as working memory and verbal fluency in 91 patients with cognitive impairment, highlighting its efficacy in addressing cognitive-emotional deficits.

Despite these improvements, a follow-up six months later revealed that nearly 45% of patients were still unable to return to their pre-COVID-19 work activities, indicating that full recovery of functional levels may not be achieved for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological rehabilitation for post-COVID-19 syndrome: results of a clinical programme and six-month follow up. García-Molina, A., García-Carmona, S., Espiña-Bou, M., et al.[2023]

A specialized cognitive-behavioral group intervention for individuals with post-COVID-19 condition was found to be feasible and well-accepted among 64 inpatients, with high satisfaction ratings for the treatment sessions.

Participants experienced significant reductions in subjective fatigue and improved coping with their condition after the intervention, indicating potential effectiveness in addressing post-COVID-19 symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for patients with post-COVID-19 condition (CBT-PCC): a feasibility trial. Huth, D., Bräscher, AK., Tholl, S., et al.[2023]

In a study of 57 COVID-19 patients undergoing rehabilitation, 81% exhibited cognitive impairment, particularly in areas like working memory and attention, highlighting significant cognitive challenges following severe illness.

The findings suggest that targeted interventions for attention and executive function may be beneficial for patients recovering from COVID-19, as these cognitive deficits were common and varied in severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and profile of objective cognitive deficits in hospitalized patients recovering from COVID-19. Jaywant, A., Vanderlind, WM., Alexopoulos, GS., et al.[2023]

The CO-OP approach significantly improved rehabilitation clinicians' knowledge and self-efficacy in implementing cognitive strategies for stroke rehabilitation, as evidenced by positive changes in multiple-choice question scores and self-efficacy assessments after a 2-day workshop and 4 months of support.

After the intervention, there was a notable increase in the use of CO-OP strategies in practice, with 20% of medical records showing evidence of CO-OP use post-intervention, indicating a shift towards more client-centered goal setting in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a function-based cognitive strategy intervention within inter-professional stroke rehabilitation teams: Changes in provider knowledge, self-efficacy and practice. McEwen, SE., Donald, M., Jutzi, K., et al.[2023]

A new initiative called CO-OP KT aims to improve access to rehabilitation for stroke patients with cognitive impairments by training healthcare professionals in a function-based approach, potentially leading to better patient outcomes.

The study will evaluate the effectiveness of CO-OP KT in changing clinician practices and improving patient activity and self-efficacy over time, using a combination of quasi-experimental designs and assessments at multiple follow-up points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-faceted knowledge translation approach to support persons with stroke and cognitive impairment: evaluation protocol. McEwen, SE., Donald, M., Dawson, D., et al.[2023]

A consensus conference involving 50 experts established clinical guidance for cognitive rehabilitation in military and civilian populations with persistent cognitive symptoms following mild traumatic brain injury, focusing on treatments effective three or more months post-injury.

The conference identified specific effective services within cognitive rehabilitation and emphasized the importance of assessment, intervention, and outcome measurement in developing treatment programs for cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation for military personnel with mild traumatic brain injury and chronic post-concussional disorder: Results of April 2009 consensus conference. Helmick, K.[2018]

Occupational therapists can enhance their role in cognitive rehabilitation by focusing on compensatory strategy training, which aligns with their expertise and history.

By increasing their involvement in research and transdisciplinary organizations, occupational therapists can lead advancements in cognitive rehabilitation, ultimately improving daily performance for individuals recovering from brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation: advancing the stature of occupational therapy. Radomski, MV.[2019]

This study is a multi-centre, randomised controlled trial involving 400 participants with multiple sclerosis, aimed at evaluating the effectiveness of a group-based cognitive rehabilitation program designed to improve memory and attention problems.

Participants will receive 10 weekly sessions focusing on both retraining cognitive functions and coping strategies, with outcomes assessed at 6 and 12 months to determine the program's clinical and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS). Lincoln, NB., das Nair, R., Bradshaw, L., et al.[2022]

References

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[Neuropsychological rehabilitation for post-COVID-19 syndrome: Results of a clinical program and six-month follow up.] [2023]

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Screening and assessment for post-acute COVID-19 syndrome (PACS), guidance by personal pilots and support with individual digital trainings within intersectoral care: a study protocol of a randomized controlled trial. [2022]

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Cognitive remediation therapy for post-acute persistent cognitive deficits in COVID-19 survivors: A proof-of-concept study. [2023]

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A proposal to apply brain injury recovery treatments for cognitive impairment in COVID-19 survivors. [2022]

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Cognitive impairment, anxiety and depression: a map of Cochrane evidence relevant to rehabilitation for people with post COVID-19 condition. [2023]

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Personalized Computerized Training for Cognitive Dysfunction after COVID-19: A Before-and-After Feasibility Pilot Study. [2023]

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Neuropsychological rehabilitation for post-COVID-19 syndrome: results of a clinical programme and six-month follow up. [2023]

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Cognitive-behavioral therapy for patients with post-COVID-19 condition (CBT-PCC): a feasibility trial. [2023]

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Frequency and profile of objective cognitive deficits in hospitalized patients recovering from COVID-19. [2023]

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Implementing a function-based cognitive strategy intervention within inter-professional stroke rehabilitation teams: Changes in provider knowledge, self-efficacy and practice. [2023]

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A multi-faceted knowledge translation approach to support persons with stroke and cognitive impairment: evaluation protocol. [2023]

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Cognitive rehabilitation for military personnel with mild traumatic brain injury and chronic post-concussional disorder: Results of April 2009 consensus conference. [2018]

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Cognitive rehabilitation: advancing the stature of occupational therapy. [2019]

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Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS). [2022]