Cognitive Rehabilitation in Post-COVID-19 Syndrome

Cognitive Strategy Training in Post-COVID-19 Syndrome: A Feasibility Trial

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.

Study Overview

• Status: Completed
• Conditions: Post-COVID-19 Syndrome
• Intervention / Treatment: Behavioral: CO-OP Procedures; Behavioral: Inactive Control Group

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • University of Missouri Department of Occupational Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Orientation to daily Occupational Performance (CO-OP); 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.	Behavioral: CO-OP Procedures; 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.
Other: 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.	Behavioral: Inactive Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM)	Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)	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)	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)	After study completion, an average of 12 weeks
Recruitment Rate	Number of participants enrolled divided by number of individuals screened	After study completion, an average of 12 weeks
Retention Rate	Number of participants completing all study procedures divided by number of participants enrolled	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.	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.	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.	Pre-intervention (week 0) and post-intervention (week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Pre-intervention (week 0) and post-intervention (week 12)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Anna E Boone, PhD, OTR/L, University of Missouri Occupational Therapy

Publications and helpful links

General Publications

• McEwen S, Polatajko H, Baum C, Rios J, Cirone D, Doherty M, Wolf T. Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):526-36. doi: 10.1177/1545968314558602. Epub 2014 Nov 21.
• Cicerone KD, Dahlberg C, Malec JF, Langenbahn DM, Felicetti T, Kneipp S, Ellmo W, Kalmar K, Giacino JT, Harley JP, Laatsch L, Morse PA, Catanese J. Evidence-based cognitive rehabilitation: updated review of the literature from 1998 through 2002. Arch Phys Med Rehabil. 2005 Aug;86(8):1681-92. doi: 10.1016/j.apmr.2005.03.024.
• Wolf TJ, Polatajko H, Baum C, Rios J, Cirone D, Doherty M, McEwen S. Combined Cognitive-Strategy and Task-Specific Training Affects Cognition and Upper-Extremity Function in Subacute Stroke: An Exploratory Randomized Controlled Trial. Am J Occup Ther. 2016 Mar-Apr;70(2):7002290010p1-7002290010p10. doi: 10.5014/ajot.2016.017293.
• Geusgens CA, van Heugten CM, Cooijmans JP, Jolles J, van den Heuvel WJ. Transfer effects of a cognitive strategy training for stroke patients with apraxia. J Clin Exp Neuropsychol. 2007 Nov;29(8):831-41. doi: 10.1080/13803390601125971.
• Haskins EC, Cicerone KD, Trexler LE. Cognitive rehabilitation manual: Translating evidence-based recommendations into practice. ACRM Publishing; 2012.
• Dawson DR, Anderson ND, Burgess P, Cooper E, Krpan KM, Stuss DT. Further development of the Multiple Errands Test: standardized scoring, reliability, and ecological validity for the Baycrest version. Arch Phys Med Rehabil. 2009 Nov;90(11 Suppl):S41-51. doi: 10.1016/j.apmr.2009.07.012.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: cognition; activities of daily living; covid-19; metacognition; telehealth
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2096158; R21HD112373-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No