Cognitive Rehabilitation in Post-COVID-19 Syndrome
- Conditions
- Post-COVID-19 Syndrome
- Interventions
- Behavioral: CO-OP ProceduresBehavioral: Inactive Control Group
- Registration Number
- NCT06136871
- Lead Sponsor
- University of Missouri-Columbia
- Brief Summary
The first aim of this study is to determine the feasibility of delivering CO-OP remotely to individuals experiencing cognitive impairments that limit everyday activities in post-COVID-19 syndrome (PCS). The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of individuals with PCS. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to an inactive control group, on activity performance, subjective and objective cognition, and quality of life in a sample of individuals who self-report PCS and cognitive impairment.
- Detailed Description
Post-COVID-19 symptoms (PCS) cognitive symptoms require the rehabilitation community to investigate ways to: (1) reduce the functional impact of the symptoms on daily life and (2) support individuals with PCS to establish new habits to improve and maintain health. While the cognitive impairment associated with PCS has not been well evaluated, it is similar of cognitive symptoms seen in other conditions. Metacognitive strategy training (MCST) approaches are an evidence-based practice standard for improving capacity to self-manage chronic cognitive symptoms and reduce their functional impact on everyday life activities.
The CO-OP approach is an MCST intervention in which participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies for engaging in an activity. Existing evidence with other populations suggests that CO-OP has more of a positive effect on improving activity performance and cognition than remediation/retraining-based approaches. These effects have been demonstrated in individuals with mild cognitive impairment that mirrors that found in PCS. The overall research hypothesis is that CO-OP can feasibly be administered remotely and will improve activity performance, subjective and objective cognitive function, and quality of life in individuals with PCS.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
- self-reported cognitive symptoms persisting for at least 6 weeks following COVID-19 infection (Cognitive Failures Questionnaire (CFQ) score >43)
- self-identified activity performance goals per the Canadian Occupational Performance Measure (COPM)
- documented prior diagnosis of COVID-19
- read, write, and speak English fluently
- ability to provide valid informed electronic consent
- diagnosis of severe neurological or psychiatric condition(s)
- dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment (MoCA)
- untreated sleep apnea (≥5 on the STOPBANG)
- prior cancer treatment
- severe depressive symptoms (>21 on the Patient Health Questionnaire-9)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Orientation to daily Occupational Performance (CO-OP) CO-OP Procedures Each CO-OP session will last 45 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform. Inactive Control Group Inactive Control Group Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
- Primary Outcome Measures
Name Time Method Feasibility measures After study completion, an average of 12 weeks Recruitment rate, retention rate
Canadian Occupational Performance Measure (COPM) Pre-intervention (week 0), week 2, week 4, week 6, week 8, and post-intervention (week 12) Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Telehealth Usability Questionnaire (TUQ) After study completion, an average of 12 weeks Measure of telehealth usability from participant's perspective. Self-report Likert scale of 1 (disagree) to 7 (agree)
Feasibility of Intervention Measure (FIM) After study completion, an average of 12 weeks Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Intervention Appropriateness Measure (IAM) After study completion, an average of 12 weeks Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Acceptability of Intervention Measure (AIM) After study completion, an average of 12 weeks Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
- Secondary Outcome Measures
Name Time Method CANTAB Spatial Working Memory Subtest Pre-intervention (week 0) and post-intervention (week 12) Objective measure of working memory and strategy.
CANTAB Delayed Matching to Sample Subtest Pre-intervention (week 0) and post-intervention (week 12) Objective measure of short-term visual recognition memory and attention. Other outcomes include latency (speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response.
CANTAB Paired Associates Learning Subtest Pre-intervention (week 0) and post-intervention (week 12) Objective measure of visual episodic memory. Other outcomes include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed.
CANTAB Stockings of Cambridge Subtest Pre-intervention (week 0) and post-intervention (week 12) Objective measure of planning and executive function. Other outcomes include problem-solving ability and time required to complete task.
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Pre-intervention (week 0) and post-intervention (week 12) Self-report measure of cognition. Maximum=5, minimum=1. Higher scores indicate fewer perceived cognitive deficits.
Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing Subtest Pre-intervention (week 0) and post-intervention (week 12) Objective measure of sustained attention. Other outcomes include latency (speed of response), probability of false alarms, and sensitivity.
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Pre-intervention (week 0) and post-intervention (week 12) Objective measure of inhibition and cognitive flexibility. Consists of 4 conditions (color naming, word reading, inhibition, and inhibition/switching). Therapist records client-corrected errors, noncorrected errors, and total time required for each domain. Increased errors and time indicate potential challenges with inhibition and cognitive flexibility.
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) Pre-intervention (week 0) and post-intervention (week 12) Self-report measure of quality of life. Maximum=5, minimum=1. Higher scores indicate greater perceived quality of life.
Trial Locations
- Locations (1)
University of Missouri Department of Occupational Therapy
🇺🇸Columbia, Missouri, United States