Clinical trial NCT06086379: Cognitive Rehabilitation Therapy for COVID-19
Official title: Cognitive Rehabilitation to Improve Functioning in Veterans Following COVID-19
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Post-Acute COVID-19 Syndrome
Keywords: Post-Acute COVID-19 Syndrome
Cognitive rehabilitation
Cognitive training
Cognitive remediation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-10-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized controlled trial
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Change in World Health Organization - Disability Assessment Schedule (WHODAS 2.0)
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change in objective cognitive performance z score
timeFrame: baseline, 8 weeks
measure: Change in functional capacity performance z score
timeFrame: baseline, 8 weeks
measure: Change in Patient Health Questionnaire 9 (PHQ-9)
timeFrame: baseline, 8 weeks
measure: Change in Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: baseline, 8 weeks
measure: Change in PTSD Checklist for DSM-5 (PCL-5)
timeFrame: baseline, 8 weeks
measure: Change in Cognitive Failures Questionnaire (CFQ)
timeFrame: baseline, 8 weeks
measure: Change in Neuro-QOL: Applied Cognition General Concerns
timeFrame: baseline, 8 weeks
measure: Change in Neuro-QOL: Applied Cognition Executive Functioning
timeFrame: baseline, 8 weeks
measure: Change in Neuro-QOL: Fatigue
timeFrame: baseline, 8 weeks
measure: Change in World Health Organization - Quality of Life (WHOQOL-BREF)
timeFrame: baseline, 8 weeks
measure: Change in Insomnia Severity Index (ISI)
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Tara A Austin, AA
role: PRINCIPAL_INVESTIGATOR
References: