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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
CO-OP is a metacognitive strategy training intervention that will be used in this study. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, we introduce the approach to the subject and teach the global cognitive strategy (i.e., GOAL-PLAN-DO-CHECK). In all subsequent sessions, this strategy is used as the main problem-solving framework to facilitate skill acquisition.The subject identifies a GOAL, and then is guided by the therapist to discover a PLAN to potentially achieve the goal. The subject is then asked to DO the plan (if feasible during the therapy session otherwise asked to complete at home prior to the next treatment session), and subsequently to CHECK to see if the plan worked, i.e. the goal was achieved. This process is repeated until satisfactory performance is met for each established goal.
An inactive control group will be used to control for maturation and testing effects. Weekly contact will be made via teleconferencing to (1) maintain study engagement, (2) introduce weekly social contact with researchers, mimicking some of the potential incidental effects of the experimental group, and (3) ascertain what, if any, additional steps participants have taken to reduce PCS symptoms. The content of each of these meetings will be tracked in intervention notes. Each contact will be recorded for fidelity monitoring to ensure all active ingredients of the CO-OP intervention are avoided.
University of Missouri Department of Occupational Therapy
Columbia, Missouri, United States
Recruitment Rate
Number of participants enrolled divided by number of individuals screened
Time frame: After study completion, an average of 12 weeks
Retention Rate
Number of participants completing all study procedures divided by number of participants enrolled
Time frame: After study completion, an average of 12 weeks
Telehealth Usability Questionnaire (TUQ)
Measure of telehealth usability from participant's perspective. Self-report Likert scale of 1 (disagree) to 7 (agree). Higher values represent a better outcome.
Time frame: After study completion, an average of 12 weeks
Acceptability of Intervention Measure (AIM)
Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Time frame: After study completion, an average of 12 weeks
Intervention Appropriateness Measure (IAM)
Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Time frame: After study completion, an average of 12 weeks
Feasibility of Intervention Measure (FIM)
Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Time frame: After study completion, an average of 12 weeks
Canadian Occupational Performance Measure (COPM) Performance, Trained Goals
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Canadian Occupational Performance Measure (COPM) Satisfaction, Trained Goals
Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Time
Objective measure of inhibition and cognitive flexibility. Data are presented for condition 4 of color/word switching. Age-adjusted scale scores are presented with a mean of 10 and a standard deviation of 3. Maximum=19, minimum=1. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Errors
Objective measure of inhibition and cognitive flexibility. Data are presented for condition 4 of color/word switching. Age-adjusted scale scores are presented with a mean of 10 and a standard deviation of 3. Maximum=19, minimum=1. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function
Self-report measure of cognition. Maximum=5, minimum=1. T-scores are reported with a mean of 50 and a standard deviation of 10. Higher scores indicate fewer perceived cognitive deficits.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing Subtest
Objective measure of sustained attention. A Z-score of 0 represents the population mean. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
CANTAB Spatial Working Memory Subtest
Objective measure of working memory and strategy. A Z-score of 0 represents the population mean. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
CANTAB Stockings of Cambridge Subtest
Objective measure of planning and executive function. A Z-score of 0 represents the population mean. Higher scores indicate better performance.
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Time frame: Pre-intervention (week 0) and post-intervention (week 12)
CANTAB Delayed Matching to Sample Subtest
Objective measure of short-term visual recognition memory and attention. A Z-score of 0 represents the population mean. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
CANTAB Paired Associates Learning Subtest
Objective measure of visual episodic memory. A Z-score of 0 represents the population mean. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Canadian Occupational Performance Measure (COPM) Performance, Untrained Goals
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Canadian Occupational Performance Measure (COPM) Satisfaction, Untrained Goals
Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Physical Domain
Self-report measure of physical health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived physical health.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Social Domain
Self-report measure of social health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived social health.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Environmental Domain
Self-report measure of environmental health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived environmental health.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Spiritual Domain
Self-report measure of spiritual health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived spiritual health.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Independence Domain
Self-report measure of independence. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived independence.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Psychological Domain
Self-report measure of psychological health. Each item is ranked on a Likert scale of 1-5 (Maximum=5, minimum=1). The range of scores for this domain is 0-100, with higher scores indicating greater perceived psychological health.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)
Cognitive Failures Questionnaires Total Score
Self-report measure of frequency of cognitive errors in daily life. Participants rate each item on a scale of 0 (never) to 4 (very often). Maximum total score=100, minimum total score=0. Higher scores indicate increased perceived cognitive errors.
Time frame: Pre-intervention (week 0) and post-intervention (week 12)