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Cognitive Rehabilitation Therapy for COVID-19 (CCT-COVID)

Primary Purpose

Post-Acute COVID-19 Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compensatory Cognitive Training for COVID-19
Holistic Cognitive Education
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Acute COVID-19 Syndrome focused on measuring Post-Acute COVID-19 Syndrome, Cognitive rehabilitation, Cognitive training, Cognitive remediation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CCT-C

HCE

Arm Description

10-week Compensatory Cognitive Training Group

10-week Holistic Cognitive Education Group

Outcomes

Primary Outcome Measures

Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0)
Change in average total score

Secondary Outcome Measures

Change in objective cognitive performance z score
Change in composite z score
Change in functional capacity performance z score
Change in composite z score
Change in Patient Health Questionnaire 9 (PHQ-9)
Change in total score
Change in Generalized Anxiety Disorder 7 (GAD-7)
Change in total score
Change in PTSD Checklist for DSM-5 (PCL-5)
Change in total score
Change in Cognitive Failures Questionnaire (CFQ)
Change in total score
Change in Neuro-QOL: Applied Cognition General Concerns
Change in total score
Change in Neuro-QOL: Applied Cognition Executive Functioning
Change in total score
Change in Neuro-QOL: Fatigue
Change in total score
Change in World Health Organization - Quality of Life (WHOQOL-BREF)
Change in total score
Change in Insomnia Severity Index (ISI)
Change in total score

Full Information

First Posted
October 13, 2023
Last Updated
October 18, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT06086379
Brief Title
Cognitive Rehabilitation Therapy for COVID-19
Acronym
CCT-COVID
Official Title
Cognitive Rehabilitation to Improve Functioning in Veterans Following COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2024 (Anticipated)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Acute COVID-19 Syndrome
Keywords
Post-Acute COVID-19 Syndrome, Cognitive rehabilitation, Cognitive training, Cognitive remediation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be blind to treatment group assignment.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CCT-C
Arm Type
Experimental
Arm Description
10-week Compensatory Cognitive Training Group
Arm Title
HCE
Arm Type
Active Comparator
Arm Description
10-week Holistic Cognitive Education Group
Intervention Type
Behavioral
Intervention Name(s)
Compensatory Cognitive Training for COVID-19
Other Intervention Name(s)
CCT-C
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Holistic Cognitive Education
Other Intervention Name(s)
HCE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0)
Description
Change in average total score
Time Frame
baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in objective cognitive performance z score
Description
Change in composite z score
Time Frame
baseline, 8 weeks
Title
Change in functional capacity performance z score
Description
Change in composite z score
Time Frame
baseline, 8 weeks
Title
Change in Patient Health Questionnaire 9 (PHQ-9)
Description
Change in total score
Time Frame
baseline, 8 weeks
Title
Change in Generalized Anxiety Disorder 7 (GAD-7)
Description
Change in total score
Time Frame
baseline, 8 weeks
Title
Change in PTSD Checklist for DSM-5 (PCL-5)
Description
Change in total score
Time Frame
baseline, 8 weeks
Title
Change in Cognitive Failures Questionnaire (CFQ)
Description
Change in total score
Time Frame
baseline, 8 weeks
Title
Change in Neuro-QOL: Applied Cognition General Concerns
Description
Change in total score
Time Frame
baseline, 8 weeks
Title
Change in Neuro-QOL: Applied Cognition Executive Functioning
Description
Change in total score
Time Frame
baseline, 8 weeks
Title
Change in Neuro-QOL: Fatigue
Description
Change in total score
Time Frame
baseline, 8 weeks
Title
Change in World Health Organization - Quality of Life (WHOQOL-BREF)
Description
Change in total score
Time Frame
baseline, 8 weeks
Title
Change in Insomnia Severity Index (ISI)
Description
Change in total score
Time Frame
baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tara A Austin, AA
Phone
(858) 642-3657
Email
tara.austin@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth W Twamley, PhD
Phone
(858) 552-8585
Ext
3848
Email
etwamley@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara A Austin, AA
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara A Austin, AA
Phone
858-642-3657
Email
tara.austin@va.gov
First Name & Middle Initial & Last Name & Degree
Tara A Austin, AA

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Rehabilitation Therapy for COVID-19

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