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Post-Acute COVID-19 SyndromeCCT-COVIDNCT06086379

Cognitive Rehabilitation Therapy for COVID-19

A study testing Compensatory Cognitive Training for COVID-19 and Holistic Cognitive Education in people with Post-Acute COVID-19 Syndrome, run by VA Office of Research and Development at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-Acute COVID-19 Syndrome
What is being tested?
Compensatory Cognitive Training for COVID-19 and Holistic Cognitive Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
1 Jul 2024to 31 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veterans > 18 years old who are able to provide informed consent
  • Prior participation in SF Parent Study or LA Parent Study
  • Report of cognitive symptoms that Veteran attributes to COVID-19 infection

Who cannot join

  • Current substance abuse disorder, psychotic disorder, dementia, etc.
  • History of moderate to severe brain injury with loss of consciousness > 30 minutes
  • Auditory or visual impairments that would prevent the ability to participate in assessment procedures
  • Invalid performance on one or more embedded performance validity tests (PVTs)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161-0002

Other trials in United States

About this study

Official title: Cognitive Rehabilitation to Improve Functioning in Veterans Following COVID-19

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.

Read the detailed description

2-8% of the US population report "long COVID" symptoms - including "brain fog," thinking difficulties, memory problems, and psychiatric symptoms such as sleep disturbance, anxiety, and depression. Rates of post-COVID-19 symptoms are nearly double in the Veteran population. These cognitive symptoms contribute to functional impairments, reduced quality of life, poorer self-reported health status, psychological distress, delayed return to work, new onset disability, reduced community integration, and increased healthcare utilization. One promising treatment to improve both everyday functioning and cognition secondary to post-COVID-19 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. The proposed CDA provides a golden opportunity to evaluate CCT for Veterans with prolonged COVID-19 symptoms (CCT-C), compared with a robust control condition, Holistic Cognitive Education (HCE). The project closely aligns with current RR\&D priorities, by "examining COVID-19-specific rehabilitation interventions and responses to treatment" and by addressing "late or delayed effects of secondary conditions related to COVID-19 infections on impairment and disability." Specific aims are 1) to conduct a pilot randomized controlled trial of remote CCT-C with 70 Veterans (35 CCT-C, 35 HCE) with post-COVID-19 cognitive symptoms to examine feasibility, acceptability, and initial efficacy; 2) to examine the preliminary efficacy of CCT-C in this population on overall functioning, as measured by the World Health Organization's Disability Assessment Schedule (WHODAS 2.0), performance-based measures of functional capacity, and secondary outcomes (cognitive performance, quality of life, self-reported cognitive problems, psychiatric symptoms, sleep disturbance, and engagement in work/community activities); and 3) to explore moderators of outcome (e.g., age, initial COVID-19 severity, baseline cognitive functioning, presence of PTSD/mTBI history; biomarkers related to COVID-19 infection).

Being tested
Compensatory Cognitive Training for COVID-19, Holistic Cognitive Education
Keywords
Post-Acute COVID-19 Syndrome, Cognitive rehabilitation, Cognitive training, Cognitive remediation
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compensatory Cognitive Training for COVID-19Behavioural

    Also called CCT-C

    CCT-C is a manualized group-based behavioral intervention (10 weeks, 2 hours per week, 20 hours total) designed to improve cognition and everyday functioning in patients with prolonged COVID-19 symptoms

  • Holistic Cognitive EducationBehavioural

    Also called HCE

    HCE provides the same frequency and amount of therapist and other group member contact as CCT-C, but does not provide training in cognitive or lifestyle strategies addressed in CCT-C. The HCE intervention provides information and discussion regarding common causes of and treatments for cognitive impairment.

Study groups in NCT06086379
Study groupRoleWhat they receive
CCT-CExperimental10-week Compensatory Cognitive Training Group
Receives: Behavioral: Compensatory Cognitive Training for COVID-19
HCEActive comparator10-week Holistic Cognitive Education Group
Receives: Behavioral: Holistic Cognitive Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0)

    Change in average total score

    Measured: baseline, 8 weeks

Secondary outcomes (11)

  1. Change in objective cognitive performance z score

    Change in composite z score

    Measured: baseline, 8 weeks

  2. Change in functional capacity performance z score

    Change in composite z score

    Measured: baseline, 8 weeks

  3. Change in Patient Health Questionnaire 9 (PHQ-9)

    Change in total score

    Measured: baseline, 8 weeks

  4. Change in Generalized Anxiety Disorder 7 (GAD-7)

    Change in total score

    Measured: baseline, 8 weeks

  5. Change in PTSD Checklist for DSM-5 (PCL-5)

    Change in total score

    Measured: baseline, 8 weeks

  6. Change in Cognitive Failures Questionnaire (CFQ)

    Change in total score

    Measured: baseline, 8 weeks

  7. Change in Neuro-QOL: Applied Cognition General Concerns

    Change in total score

    Measured: baseline, 8 weeks

  8. Change in Neuro-QOL: Applied Cognition Executive Functioning

    Change in total score

    Measured: baseline, 8 weeks

  9. Change in Neuro-QOL: Fatigue

    Change in total score

    Measured: baseline, 8 weeks

  10. Change in World Health Organization - Quality of Life (WHOQOL-BREF)

    Change in total score

    Measured: baseline, 8 weeks

  11. Change in Insomnia Severity Index (ISI)

    Change in total score

    Measured: baseline, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2023
  2. Study start1 Jul 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two group randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06086379
Sponsor's protocol ID
E4764-W
Acronym
CCT-COVID
Status last verified
Jul 2026
First submitted
13 Oct 2023
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Compensatory Cognitive Training for COVID-19 and Holistic Cognitive Education in people with Post-Acute COVID-19 Syndrome, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0) (time frame: baseline, 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06086379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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