AzTrials
AzTrials

Post-COVID-19 SyndromeNCT06136871

Cognitive Rehabilitation in Post-COVID-19 Syndrome

A study testing CO-OP Procedures in people with Post-COVID-19 Syndrome, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Post-COVID-19 Syndrome
What is being tested?
CO-OP Procedures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
1 Feb 2024to 30 Jun 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Missouri Department of Occupational Therapy

    Columbia, Missouri, 65211

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
CO-OP Procedures, Inactive Control Group
Keywords
covid-19, metacognition, cognition, telehealth, activities of daily living
Medical subject headings
Post-Acute COVID-19 Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CO-OP ProceduresBehavioural

    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 GroupBehavioural

    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.

Study groups in NCT06136871
Study groupRoleWhat they receive
Cognitive Orientation to daily Occupational Performance (CO-OP)ExperimentalEach 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.
Receives: Behavioral: CO-OP Procedures
Inactive Control GroupOtherSubjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
Receives: Behavioral: Inactive Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Number of participants enrolled divided by number of individuals screened

    Measured: After study completion, an average of 12 weeks

  2. Retention Rate

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

    Measured: After study completion, an average of 12 weeks

  3. 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.

    Measured: After study completion, an average of 12 weeks

  4. Acceptability of Intervention Measure (AIM)

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

    Measured: After study completion, an average of 12 weeks

  5. Intervention Appropriateness Measure (IAM)

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

    Measured: After study completion, an average of 12 weeks

  6. Feasibility of Intervention Measure (FIM)

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

    Measured: After study completion, an average of 12 weeks

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

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

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  8. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

Secondary outcomes (17)
  1. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  2. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  3. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  4. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  5. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  6. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  7. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  8. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

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

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

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  10. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  11. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  13. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  14. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  15. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  16. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

  17. 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.

    Measured: Pre-intervention (week 0) and post-intervention (week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Feb 2024
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
After baseline assessment, subjects will be randomized to one of two groups: (1) a 10-session Cognitive Orientation to daily Occupational Performance (CO-OP) intervention; or (2) a 10-session inactive control group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06136871
Sponsor's protocol ID
2096158
Other IDs
R21HD112373-01
Status last verified
Nov 2025
First submitted
14 Nov 2023
Last updated
13 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25416738
  • 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.

    PubMed 18030634
  • Haskins EC, Cicerone KD, Trexler LE. Cognitive rehabilitation manual: Translating evidence-based recommendations into practice. ACRM Publishing; 2012.

  • 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.

    PubMed 16084827
  • 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.

    PubMed 19892074
  • 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.

    PubMed 26943113

Questions about this trial

What is this clinical trial studying?

A study testing CO-OP Procedures in people with Post-COVID-19 Syndrome, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: After study completion, an average of 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06136871, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in