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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals experiencing cognitive difficulties after COVID-19. It involves an online program called CO-OP (Cognitive Orientation to daily Occupational Performance), designed to enhance daily activities and quality of life. Participants will be divided into two groups: one will engage in the CO-OP program, while the other will not receive active treatment. Suitable candidates for this trial have ongoing memory or concentration issues that began after a COVID-19 infection and seek to improve their daily task performance. As an unphased trial, this study provides a unique opportunity for participants to potentially enhance their daily lives through innovative treatment.

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 prior data suggests that CO-OP Procedures are safe for individuals with post-COVID syndrome?

A previous study found the CO-OP (Cognitive Orientation to daily Occupational Performance) method to be both helpful and well-received. It improved participants' performance in daily tasks and their satisfaction with those tasks, while also aiding mood and anxiety. However, the studies reviewed did not provide specific safety information about using CO-OP for post-COVID syndrome, leaving no direct evidence of harmful effects from CO-OP itself.

Generally, methods like CO-OP are non-invasive, meaning they don't involve surgery or entering the body. They focus on improving thinking and planning skills through practice and support. These treatments are usually easy for participants to handle. If CO-OP had major safety issues, researchers likely wouldn't use it in studies. So, even without detailed safety data, the nature of the treatment suggests it is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cognitive Orientation to daily Occupational Performance (CO-OP) approach for Post-COVID Syndrome because it offers a unique, non-pharmacological method to address cognitive rehabilitation. Unlike standard treatments that might focus on medication or general cognitive exercises, CO-OP is a tailored strategy that helps individuals develop personalized skills to improve their daily functioning. This method is delivered remotely, making it accessible and convenient for participants, especially those who may still be experiencing mobility issues or prefer at-home care. By focusing on practical, goal-oriented tasks, CO-OP has the potential to provide significant, tangible benefits in daily life activities for those recovering from the cognitive impacts of COVID-19.

What evidence suggests that CO-OP Procedures could be effective for post-COVID syndrome?

Research has shown that the CO-OP (Cognitive Orientation to daily Occupational Performance) approach, which participants in this trial may receive, can enhance thinking skills in individuals with post-COVID syndrome. A similar method, cognitive remediation therapy, has effectively improved skills such as clear speech and task planning. Participants in programs like CO-OP have reported better cognitive abilities and improved daily performance. Studies also suggest that rehabilitation strategies can help manage long COVID symptoms, including mental and physical health issues. This evidence indicates that CO-OP could benefit those experiencing cognitive difficulties after COVID-19. ^{1 2 3 6 7}

Who Is on the Research Team?

Anna E Boone, PhD, OTR/L

Principal Investigator

University of Missouri Occupational Therapy

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06136871

Cognitive Rehabilitation in Post-COVID-19 Syndrome CO-OP is a metacognitive strategy training intervention that will be used in this study. First, five functional, everyday life goals are identified ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11600537/

Interventions for the management of long covid (post-covid ... Conclusion. Moderate certainty evidence suggests that CBT and physical and mental health rehabilitation probably improve symptoms of long covid.

3. withpower.com withpower.com/trial/phase-covid-19-11-2023-4690e

Cognitive Rehabilitation for 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11687220/

Outpatient group therapy for post-COVID patients The aim of this study was to develop a low-threshold group therapy concept for patients with PCS and to test its feasibility in face-to-face and online format.

5. researchgate.net researchgate.net/figure/Cognitive-Orientation-to-daily-Occupational-Performance-CO-OP_fig1_50353089

Cognitive Orientation to daily Occupational Performance ... Design: Sixteen community residents ≥3 months post-COVID-19 infection with mild cognitive impairment and dysfunction in instrumental activities of daily living ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11464456/

Cognitive Orientation to daily Occupational Performance ... CO-OP was perceived as acceptable and beneficial in enhancing occupational performance, satisfaction and managing mood and anxiety symptoms.

7. research.aota.org research.aota.org/ajot/article/75/Supplement_1/7511347010/13503/A-Framework-for-Addressing-Clients-Functional

A Framework for Addressing Clients' Functional Cognitive ... When working with people with COVID-19 long-haul syndrome, occupational therapy practitioners should stay focused on supporting clients' goals, ...