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Enrolling by Invitation

NCT Number: NCT06086379

Cognitive Rehabilitation Therapy for 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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Compensatory Cognitive Training for COVID-19

Behavioral

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

Other names: CCT-C

Holistic Cognitive Education

Behavioral

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.

Other names: HCE

Primary outcomes

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

    Time frame: baseline, 8 weeks

    Change in average total score

Secondary outcomes

  1. Change in objective cognitive performance z score

    Time frame: baseline, 8 weeks

    Change in composite z score

  2. Change in functional capacity performance z score

    Time frame: baseline, 8 weeks

    Change in composite z score

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

    Time frame: baseline, 8 weeks

    Change in total score

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

    Time frame: baseline, 8 weeks

    Change in total score

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

    Time frame: baseline, 8 weeks

    Change in total score

  6. Change in Cognitive Failures Questionnaire (CFQ)

    Time frame: baseline, 8 weeks

    Change in total score

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

    Time frame: baseline, 8 weeks

    Change in total score

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

    Time frame: baseline, 8 weeks

    Change in total score

  9. Change in Neuro-QOL: Fatigue

    Time frame: baseline, 8 weeks

    Change in total score

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

    Time frame: baseline, 8 weeks

    Change in total score

  11. Change in Insomnia Severity Index (ISI)

    Time frame: baseline, 8 weeks

    Change in total score

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Cognitive Rehabilitation to Improve Functioning in Veterans Following COVID-19

Acronym: CCT-COVID

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Oct 17, 2023
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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