NCT06136871

Cognitive Rehabilitation in Post-COVID-19 Syndrome

Completed NA Results posted Last updated 13 March 2026

What this trial tests

NA trial testing CO-OP Procedures in Post-COVID-19 Syndrome in 65 participants. Completed in 30 June 2025.

Timeline

1 February 2024

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	University of Missouri-Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	65
Start date	1 February 2024
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	1 location across United States

Drugs / interventions tested

• CO-OP Procedures
• Inactive Control Group

Conditions studied

• Post-COVID-19 Syndrome — all drugs for Post-COVID-19 Syndrome →

Sponsor

University of Missouri-Columbia

Who can join

Adults 18 to 60, any sex, with Post-COVID-19 Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recruitment Rate Primary · After study completion, an average of 12 weeks

Number of participants enrolled divided by number of individuals screened

Group	Value	95% CI
Overall	65

Retention Rate Primary · After study completion, an average of 12 weeks

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

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	21
Inactive Control Group	27

Telehealth Usability Questionnaire (TUQ) Primary · 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.

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	5.834	± 0.789
Inactive Control Group	5.688	± 0.943

Acceptability of Intervention Measure (AIM) Primary · After study completion, an average of 12 weeks

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

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	4.381	± 0.636
Inactive Control Group	2.676	± 1.040

Intervention Appropriateness Measure (IAM) Primary · After study completion, an average of 12 weeks

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

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	4.29	± 0.77
Inactive Control Group	2.29	± 1.07

Feasibility of Intervention Measure (FIM) Primary · After study completion, an average of 12 weeks

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

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	4.55	± 0.48
Inactive Control Group	3.69	± 0.81

Canadian Occupational Performance Measure (COPM) Performance, Trained Goals Primary · Pre-intervention (week 0) and post-intervention (week 12)

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

Pre-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	4.343	± 1.238
Inactive Control Group	3.833	± 1.035

Post-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	6.745	± 1.398
Inactive Control Group	4.685	± 1.449

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

Pre-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	10.000	± 4.183
Inactive Control Group	9.963	± 3.695

Post-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	10.952	± 3.309
Inactive Control Group	11.074	± 2.772

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

Pre-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	11.429	± 1.165
Inactive Control Group	10.704	± 2.478

Post-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	11.667	± 0.483
Inactive Control Group	11.148	± 0.989

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

Pre-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	35.486	± 3.217
Inactive Control Group	33.844	± 3.605

Post-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	38.343	± 5.071
Inactive Control Group	36.930	± 5.740

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

Pre-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	0.339	± 0.902
Inactive Control Group	0.394	± 0.759

Post-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	0.742	± 1.226
Inactive Control Group	0.707	± 0.939

CANTAB Spatial Working Memory Subtest Secondary · 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.

Pre-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	0.588	± 1.320
Inactive Control Group	0.263	± 1.410

Post-Testing

Group	Value	95% CI
Cognitive Orientation to Daily Occupational Performance (CO-OP)	1.080	± 1.465
Inactive Control Group	0.744	± 1.420

Adverse events — posted to ClinicalTrials.gov

Time frame: Through study completion, up to 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitive Orientation to Daily Occupational Performance (CO-OP)

Serious: 0/21 (0%)

Deaths: 0/21

Inactive Control Group

Serious: 0/27 (0%)

Deaths: 0/27

Other adverse events (1 terms — click to expand)

Reaction	System	Cognitive Orientation to D…	Inactive Control Group
ER Visit	General disorders	—	—

Data from ClinicalTrials.gov NCT06136871 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.