Cognitive Rehabilitation Therapy for COVID-19

NCT06086379 | Enrolling By Invitation

• 1 other identifier: E4764-W
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

Post-Acute COVID-19 Syndrome; Cognitive rehabilitation; Cognitive training; Cognitive remediation

Outcome Measures

Primary Outcomes (1)

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

  Change in average total score

  baseline, 8 weeks

Secondary Outcomes (11)

• Change in objective cognitive performance z score

  baseline, 8 weeks

• Change in functional capacity performance z score

  baseline, 8 weeks

• Change in Patient Health Questionnaire 9 (PHQ-9)

  baseline, 8 weeks

• Change in Generalized Anxiety Disorder 7 (GAD-7)

  baseline, 8 weeks

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

  baseline, 8 weeks

Study Arms (2)

CCT-C

EXPERIMENTAL

10-week Compensatory Cognitive Training Group

Behavioral: Compensatory Cognitive Training for COVID-19

HCE

ACTIVE COMPARATOR

10-week Holistic Cognitive Education Group

Behavioral: Holistic Cognitive Education

Interventions

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

Also known as: CCT-C

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.

Also known as: HCE

HCE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

HCE

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tara A Austin, AA

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blind to treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two group randomized controlled trial

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 17, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)