- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06086379
Cognitive Rehabilitation Therapy for COVID-19 (CCT-COVID)
July 13, 2026 updated by: VA Office of Research and Development
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92161-0002
- VA San Diego Healthcare System, San Diego, CA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CCT-C
10-week Compensatory Cognitive Training Group
|
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:
|
|
Active Comparator: HCE
10-week Holistic Cognitive Education Group
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0)
Time Frame: baseline, 8 weeks
|
Change in average total score
|
baseline, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in objective cognitive performance z score
Time Frame: baseline, 8 weeks
|
Change in composite z score
|
baseline, 8 weeks
|
|
Change in functional capacity performance z score
Time Frame: baseline, 8 weeks
|
Change in composite z score
|
baseline, 8 weeks
|
|
Change in Patient Health Questionnaire 9 (PHQ-9)
Time Frame: baseline, 8 weeks
|
Change in total score
|
baseline, 8 weeks
|
|
Change in Generalized Anxiety Disorder 7 (GAD-7)
Time Frame: baseline, 8 weeks
|
Change in total score
|
baseline, 8 weeks
|
|
Change in PTSD Checklist for DSM-5 (PCL-5)
Time Frame: baseline, 8 weeks
|
Change in total score
|
baseline, 8 weeks
|
|
Change in Cognitive Failures Questionnaire (CFQ)
Time Frame: baseline, 8 weeks
|
Change in total score
|
baseline, 8 weeks
|
|
Change in Neuro-QOL: Applied Cognition General Concerns
Time Frame: baseline, 8 weeks
|
Change in total score
|
baseline, 8 weeks
|
|
Change in Neuro-QOL: Applied Cognition Executive Functioning
Time Frame: baseline, 8 weeks
|
Change in total score
|
baseline, 8 weeks
|
|
Change in Neuro-QOL: Fatigue
Time Frame: baseline, 8 weeks
|
Change in total score
|
baseline, 8 weeks
|
|
Change in World Health Organization - Quality of Life (WHOQOL-BREF)
Time Frame: baseline, 8 weeks
|
Change in total score
|
baseline, 8 weeks
|
|
Change in Insomnia Severity Index (ISI)
Time Frame: baseline, 8 weeks
|
Change in total score
|
baseline, 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tara A Austin, AA, VA San Diego Healthcare System, San Diego, CA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
March 31, 2029
Study Registration Dates
First Submitted
October 13, 2023
First Submitted That Met QC Criteria
October 13, 2023
First Posted (Actual)
October 17, 2023
Study Record Updates
Last Update Posted (Actual)
July 15, 2026
Last Update Submitted That Met QC Criteria
July 13, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- COVID-19
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Pathological Conditions, Signs and Symptoms
- Post-Acute COVID-19 Syndrome
- HCE
Other Study ID Numbers
- E4764-W
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
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