Cognitive Rehabilitation Therapy for COVID-19
- Conditions
- Post-Acute COVID-19 Syndrome
- Interventions
- Behavioral: Compensatory Cognitive Training for COVID-19Behavioral: Holistic Cognitive Education
- Registration Number
- NCT06086379
- Lead Sponsor
- VA Office of Research and Development
- 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).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 70
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CCT-C Compensatory Cognitive Training for COVID-19 10-week Compensatory Cognitive Training Group HCE Holistic Cognitive Education 10-week Holistic Cognitive Education Group
- Primary Outcome Measures
Name Time Method Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0) baseline, 8 weeks Change in average total score
- Secondary Outcome Measures
Name Time Method Change in objective cognitive performance z score baseline, 8 weeks Change in composite z score
Change in Cognitive Failures Questionnaire (CFQ) baseline, 8 weeks Change in total score
Change in PTSD Checklist for DSM-5 (PCL-5) baseline, 8 weeks Change in total score
Change in Neuro-QOL: Applied Cognition Executive Functioning baseline, 8 weeks Change in total score
Change in Neuro-QOL: Fatigue baseline, 8 weeks Change in total score
Change in World Health Organization - Quality of Life (WHOQOL-BREF) baseline, 8 weeks Change in total score
Change in Insomnia Severity Index (ISI) baseline, 8 weeks Change in total score
Change in functional capacity performance z score baseline, 8 weeks Change in composite z score
Change in Patient Health Questionnaire 9 (PHQ-9) baseline, 8 weeks Change in total score
Change in Generalized Anxiety Disorder 7 (GAD-7) baseline, 8 weeks Change in total score
Change in Neuro-QOL: Applied Cognition General Concerns baseline, 8 weeks Change in total score
Trial Locations
- Locations (1)
VA San Diego Healthcare System, San Diego, CA
🇺🇸San Diego, California, United States