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

70 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.

What data supports the effectiveness of the treatment Compensatory Cognitive Training for COVID-19, Holistic Cognitive Education?

Research suggests that cognitive training interventions, like those used in other studies for post-COVID-19 cognitive impairment, can help improve cognitive performance and mental health. Additionally, similar programs combining cognitive training with mindfulness or neuromodulation have shown promise in enhancing quality of life and cognitive function in long COVID patients. ^{1 2 3 4 5}

Is Cognitive Rehabilitation Therapy for Long COVID Syndrome safe for humans?

The research articles provided do not contain specific safety data for Cognitive Rehabilitation Therapy or its related programs for Long COVID Syndrome. However, these therapies often involve non-invasive techniques like cognitive training, meditation, and mindfulness, which are generally considered safe for humans. ^{1 2 3 5 6}

How does the treatment Compensatory Cognitive Training for COVID-19 differ from other treatments for Long COVID?

Compensatory Cognitive Training for COVID-19 is unique because it focuses on cognitive rehabilitation specifically tailored for Long COVID, addressing cognitive impairments through structured cognitive exercises. Unlike other treatments, it does not rely on physical exercise or neuromodulation techniques like transcranial direct current stimulation (tDCS), making it a non-invasive option that directly targets cognitive function. ^{1 2 3 6 7}

What is the purpose of this trial?

Cognitive dysfunction, psychiatric symptoms, functional impairment, and disability following COVID-19 negatively impact Veterans' community functioning and quality of life, contribute to significant human suffering, and are costly to VHA. Rehabilitation is a critical priority for Veterans with long COVID. One promising treatment to improve functioning in Veterans with post-COVID-19 cognitive symptoms is Compensatory Cognitive Training (CCT). Previous studies have found that CCT is feasible, acceptable, and efficacious in Veteran populations with multiple sources of cognitive dysfunction. This randomized controlled trial aims to address important RR\&D priorities by examining feasibility, acceptability, and preliminary efficacy of a COVID-19-specific rehabilitation intervention, CCT for long COVID (CCT-C) compared to a robust control condition. The proposed study has the potential to improve cognitive function, functional independence, and quality of life for Veterans with late or delayed effects of secondary conditions related to COVID-19 infections.

Research Team

Tara A Austin, AA

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Positive Impacts of a Four-Week Neuro-Meditation Program on Cognitive Function in Post-Acute Sequelae of COVID-19 Patients: A Randomized Controlled Trial. [2023]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an amygdala and insula retraining program combined with mindfulness training to improve the quality of life in patients with long COVID: a randomized controlled trial protocol. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in post-COVID-19 condition: A study protocol for a randomized controlled trial. [2023]

5. Netherlands 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Experiences of improvement of everyday life following a rehabilitation programme for people with long-term cognitive effects of COVID-19: Qualitative study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Rehabilitation in Long-COVID-19 Patients with Persistent Breathlessness and Fatigue: The COVID-Rehab Study. [2022]