Cognitive Rehabilitation Therapy for Long COVID Syndrome

(CCT-COVID Trial)

Overseen By Elizabeth W Twamley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance abuse, Psychotic disorder, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist Veterans experiencing cognitive difficulties after COVID-19. It compares two types of cognitive training to determine which improves thinking skills, independence, and quality of life. One group will receive Compensatory Cognitive Training, while the other will undergo Holistic Cognitive Education. Veterans who believe their cognitive issues began after a COVID-19 infection and participated in certain previous studies might be suitable for this trial.

As an unphased study, this trial provides Veterans with a unique opportunity to explore innovative cognitive training methods that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have found Compensatory Cognitive Training (CCT) to be practical and well-received by people with cognitive issues. Research shows that CCT can improve thinking skills without causing major side effects. Participants found it manageable and useful for addressing brain fog and other cognitive challenges.

Specific safety data for Holistic Cognitive Education (HCE) is not available. However, HCE is generally considered safe because it focuses on overall mental health and learning. Notably, neither CCT nor HCE involves medication, often resulting in fewer side effects.

Overall, both CCT and HCE have been well-tolerated by similar groups, suggesting they are safe options for managing cognitive symptoms related to long COVID. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Compensatory Cognitive Training (CCT-C) and Holistic Cognitive Education (HCE) for Long COVID Syndrome because they offer innovative approaches to improving cognitive function. Unlike traditional treatments that might focus on medication or managing symptoms, these methods aim to directly enhance cognitive skills through structured mental exercises and holistic education. CCT-C is distinctive as it provides targeted strategies to help individuals compensate for cognitive difficulties, potentially speeding up recovery. HCE takes a comprehensive approach, focusing on overall cognitive enhancement and education, which could lead to long-term cognitive health benefits. Both treatments provide a fresh perspective by directly addressing cognitive rehabilitation, which is a promising shift from conventional care.

What evidence suggests that this trial's treatments could be effective for long COVID?

In this trial, participants will join one of two treatment arms. Compensatory Cognitive Training (CCT), which some participants may receive, has been shown in previous studies to effectively improve thinking skills in people with long COVID. Research suggests that CCT can aid focus and planning, crucial for managing tasks and staying organized. It has proven practical and helpful for veterans facing cognitive challenges. Meanwhile, Holistic Cognitive Education, another treatment option in this trial, aims to address the broader effects of long COVID, though specific information on its effectiveness is limited. Overall, both treatments are designed to alleviate the mental fog and memory problems associated with long COVID. ^{4 6 7 8 9}

Who Is on the Research Team?

Tara A Austin, AA

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for Veterans over 18 who've had COVID-19 and are struggling with cognitive issues they believe are due to the infection. They must have been part of SF or LA Parent Studies, can consent, and not have substance abuse, severe mental disorders like psychosis or dementia, major brain injury history, or sensory impairments that hinder participation.

Inclusion Criteria

I have memory or thinking problems I believe are from COVID-19.

Prior participation in SF Parent Study or LA Parent Study

I am a veteran over 18 and can give informed consent.

Exclusion Criteria

You currently have problems with drugs or alcohol, severe mental illness, or memory loss.

I do not have hearing or vision problems that would stop me from joining in assessments.

I have had a serious brain injury where I was unconscious for more than 30 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week Compensatory Cognitive Training (CCT) or Holistic Cognitive Education (HCE) program

10 weeks

Remote sessions

Follow-up

Participants are monitored for changes in cognitive performance, psychiatric symptoms, and quality of life

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Compensatory Cognitive Training for COVID-19
• Holistic Cognitive Education

Trial Overview The study tests Cognitive Rehabilitation Therapy specifically designed for long COVID (CCT-C) against a control condition to see if it helps improve thinking skills, independence in daily activities, and overall quality of life in Veterans suffering from post-COVID cognitive symptoms.

How Is the Trial Designed?

Group I: CCT-C Experimental Treatment 1 Intervention

10-week Compensatory Cognitive Training Group

Group II: HCE Active Control 1 Intervention

10-week Holistic Cognitive Education Group

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The COVID-Rehab study aims to evaluate the effectiveness of an eight-week cardiopulmonary rehabilitation program on improving cardiorespiratory fitness in 40 individuals suffering from long COVID-19, with assessments on various health aspects including quality of life and cognitive function.

This randomized clinical trial will compare a structured exercise program against a control group maintaining their usual habits, addressing the lack of specific rehabilitation guidelines for long COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Rehabilitation in Long-COVID-19 Patients with Persistent Breathlessness and Fatigue: The COVID-Rehab Study. Besnier, F., Bérubé, B., Malo, J., et al.[2022]

A community-based Long Covid support service combining psycho-educational and mind-body approaches showed positive outcomes, with participants reporting improvements in mental, physical, emotional, and spiritual wellbeing as measured by the Warwick Holistic Health Questionnaire.

Out of 25 participants, 16 showed significant improvement in their wellbeing scores after engaging with the service, indicating that this complementary approach is beneficial for individuals experiencing health challenges from Long Covid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A service evaluation of a community project combining psychoeducation and mind-body complementary approaches to support those with long covid in the UK. Brough, DN., Abel, S., Priddle, L.[2023]

This study will investigate the effects of cognitive training, with and without transcranial direct current stimulation (tDCS), on cognitive performance and quality of life in patients experiencing cognitive impairments after COVID-19, involving a 3-week intervention period.

The primary outcome will focus on improvements in working memory, assessed through an n-back task, with secondary outcomes including overall cognitive performance and health-related quality of life measured at post-intervention and one month later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation through brain stimulation-assisted cognitive training in patients with post-COVID-19 cognitive impairment (Neuromod-COV): study protocol for a PROBE phase IIb trial. Thams, F., Antonenko, D., Fleischmann, R., et al.[2022]

This study will evaluate the effectiveness of Goal Management Training (GMT) in improving attention and executive functions in 240 adults who have persistent cognitive deficits after COVID-19, with results expected at six months post-treatment.

Participants will be randomly assigned to either the GMT group or a waitlist control, allowing for a comparison of cognitive improvements, which could lead to evidence-based treatment options for common post-COVID-19 cognitive issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in post-COVID-19 condition: A study protocol for a randomized controlled trial. Hagen, BI., Lerdal, A., Søraas, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9533592/

Cognitive rehabilitation in post-COVID-19 condition The present study aims to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05338749

Computer Cognitive Training for Post-acute COVID-19 ... Study Overview. This study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in ...

3. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/15394492251328310

Cognitive Interventions and Rehabilitation to Address Long ... Individuals with long COVID cognitive symptoms clinically evaluated using the Assessment of post-acute sequelae of Sars-Cov2 (A-PASC) inventory.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525000369

Cognitive and Psychological Symptoms in Post-COVID-19 ... This review highlights the complex neurological underpinnings of PCC and the potential of NIBS and cognitive rehabilitation as interventions.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08156-z

RECOVER-NEURO: study protocol for a multi-center ... - Trials This study is designed to test whether cognitive dysfunction symptoms can be alleviated by the use of pragmatic and established interventions with different ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40848897/

A randomized, double-blind, sham-controlled trial Post-acute sequelae of SARS-CoV-2 infection (PASC) is characterized by persistent cognitive deficits alongside anxiety and depression ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05338749

Computer Cognitive Training for Post-acute COVID-19 ... This study will assess the acceptability, feasibility, and impact of game-based computer-delivered cognitive training on cognitive function in persons with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11405338/

Exploring cognitive impairments and the efficacy of ... This study examined the impact of PACS/PACVS on cognitive performance and evaluated phosphatidylcholine and CCT as potential treatment options.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04956887

Cognitive Training in Survivors of Covid-19: A Randomized ... The Investigators propose a pilot study in 100 cognitively impaired community dwelling patients who tested positive for Covid-19 and are participants in an ...