VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002, United States
NCT Number: NCT06086379
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92161-0002, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: baseline, 8 weeks
Change in average total score
Time frame: baseline, 8 weeks
Change in composite z score
Time frame: baseline, 8 weeks
Change in composite z score
Time frame: baseline, 8 weeks
Change in total score
Time frame: baseline, 8 weeks
Change in total score
Time frame: baseline, 8 weeks
Change in total score
Time frame: baseline, 8 weeks
Change in total score
Time frame: baseline, 8 weeks
Change in total score
Time frame: baseline, 8 weeks
Change in total score
Time frame: baseline, 8 weeks
Change in total score
Time frame: baseline, 8 weeks
Change in total score
Time frame: baseline, 8 weeks
Change in total score
VA Office of Research and Development
Fed
Cognitive Rehabilitation to Improve Functioning in Veterans Following COVID-19
Acronym: CCT-COVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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