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Completed

NCT Number: NCT06136871

Cognitive Rehabilitation in Post-COVID-19 Syndrome

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.

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Key information

Conditions

Post-COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri Department of Occupational Therapy

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CO-OP Procedures

Behavioral

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.

Inactive Control Group

Behavioral

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.

Primary outcomes

  1. Recruitment Rate

    Time frame: After study completion, an average of 12 weeks

    Number of participants enrolled divided by number of individuals screened

  2. Retention Rate

    Time frame: After study completion, an average of 12 weeks

    Number of participants completing all study procedures divided by number of participants enrolled

  3. Telehealth Usability Questionnaire (TUQ)

    Time frame: 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). Higher values represent a better outcome.

  4. Acceptability of Intervention Measure (AIM)

    Time frame: After study completion, an average of 12 weeks

    Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

  5. Intervention Appropriateness Measure (IAM)

    Time frame: After study completion, an average of 12 weeks

    Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

  6. Feasibility of Intervention Measure (FIM)

    Time frame: After study completion, an average of 12 weeks

    Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

  7. Canadian Occupational Performance Measure (COPM) Performance, Trained Goals

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

  8. Canadian Occupational Performance Measure (COPM) Satisfaction, Trained Goals

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.

Secondary outcomes

  1. Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Time

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

  2. Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Errors

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

  4. Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing Subtest

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    Objective measure of sustained attention. A Z-score of 0 represents the population mean. Higher scores indicate better performance.

  5. CANTAB Spatial Working Memory Subtest

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    Objective measure of working memory and strategy. A Z-score of 0 represents the population mean. Higher scores indicate better performance.

  6. CANTAB Stockings of Cambridge Subtest

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    Objective measure of planning and executive function. A Z-score of 0 represents the population mean. Higher scores indicate better performance.

  7. CANTAB Delayed Matching to Sample Subtest

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    Objective measure of short-term visual recognition memory and attention. A Z-score of 0 represents the population mean. Higher scores indicate better performance.

  8. CANTAB Paired Associates Learning Subtest

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    Objective measure of visual episodic memory. A Z-score of 0 represents the population mean. Higher scores indicate better performance.

  9. Canadian Occupational Performance Measure (COPM) Performance, Untrained Goals

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

  10. Canadian Occupational Performance Measure (COPM) Satisfaction, Untrained Goals

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.

  11. World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Physical Domain

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

  12. World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Social Domain

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

  13. World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Environmental Domain

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

  14. World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Spiritual Domain

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

  15. World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Independence Domain

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

  16. World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Psychological Domain

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

  17. Cognitive Failures Questionnaires Total Score

    Time frame: Pre-intervention (week 0) and post-intervention (week 12)

    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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Mar 13, 2026

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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