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CCT-COVID: Cognitive Rehabilitation Therapy for COVID-19

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT06086379
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Compensatory Cognitive Training for COVID-19
  • Behavioral: Holistic Cognitive Education
 N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two group randomized controlled trialTwo group randomized controlled trial
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcomes assessors will be blind to treatment group assignment.
Primary Purpose:
Treatment
Official Title:
Cognitive Rehabilitation to Improve Functioning in Veterans Following COVID-19
Anticipated Study Start Date :
Apr 1, 2024
Anticipated Primary Completion Date :
Mar 31, 2026
Anticipated Study Completion Date :
Mar 31, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: CCT-C

10-week Compensatory Cognitive Training Group

Behavioral: Compensatory Cognitive Training for COVID-19
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

    		•
    Active Comparator: HCE

    10-week Holistic Cognitive Education Group

    Behavioral: Holistic Cognitive Education
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0) [baseline, 8 weeks]

      Change in average total score

    Secondary Outcome Measures

    1. Change in objective cognitive performance z score [baseline, 8 weeks]

      Change in composite z score

    2. Change in functional capacity performance z score [baseline, 8 weeks]

      Change in composite z score

    3. Change in Patient Health Questionnaire 9 (PHQ-9) [baseline, 8 weeks]

      Change in total score

    4. Change in Generalized Anxiety Disorder 7 (GAD-7) [baseline, 8 weeks]

      Change in total score

    5. Change in PTSD Checklist for DSM-5 (PCL-5) [baseline, 8 weeks]

      Change in total score

    6. Change in Cognitive Failures Questionnaire (CFQ) [baseline, 8 weeks]

      Change in total score

    7. Change in Neuro-QOL: Applied Cognition General Concerns [baseline, 8 weeks]

      Change in total score

    8. Change in Neuro-QOL: Applied Cognition Executive Functioning [baseline, 8 weeks]

      Change in total score

    9. Change in Neuro-QOL: Fatigue [baseline, 8 weeks]

      Change in total score

    10. Change in World Health Organization - Quality of Life (WHOQOL-BREF) [baseline, 8 weeks]

      Change in total score

    11. Change in Insomnia Severity Index (ISI) [baseline, 8 weeks]

      Change in total score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA San Diego Healthcare System, San Diego, CA San Diego California United States 92161-0002

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Tara A Austin, AA, VA San Diego Healthcare System, San Diego, CA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT06086379
    Other Study ID Numbers:
    • E4764-W
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Post-Acute COVID-19 Syndrome
    Cognitive rehabilitation
    Cognitive training
    Cognitive remediation
    Additional relevant MeSH terms:
    COVID-19
    Post-Acute COVID-19 Syndrome

    Study Results

    No Results Posted as of Oct 23, 2023