Trial Outcomes & Findings for Cognitive Rehabilitation in Post-COVID-19 Syndrome (NCT NCT06136871)
NCT ID: NCT06136871
Last Updated: 2026-03-13
Results Overview
Number of participants enrolled divided by number of individuals screened
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
After study completion, an average of 12 weeks
Results posted on
2026-03-13
Participant Flow
Dates of the recruitment period: February 2024-April 2025 Types of recruitment: email newsletters, social media posts (Facebook, Instagram, Twitter), flyers in the community, websites (Research Match, University of Missouri Research, Innovation, \& Impact).
One participant was enrolled and signed written consent but withdrew during baseline assessment. Therefore, this participant was never randomized.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
COMPLETED
|
21
|
27
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Rehabilitation in Post-COVID-19 Syndrome
Baseline characteristics by cohort
| Measure |
Cognitive Orientation to Daily Occupational Performance (CO-OP)
n=21 Participants
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.
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.000 years
STANDARD_DEVIATION 12.100 • n=41 Participants
|
41.667 years
STANDARD_DEVIATION 11.300 • n=39 Participants
|
40.06 years
STANDARD_DEVIATION 11.68 • n=80 Participants
|
|
Sex/Gender, Customized
Female
|
16 Participants
n=41 Participants
|
22 Participants
n=39 Participants
|
38 Participants
n=80 Participants
|
|
Sex/Gender, Customized
Male
|
4 Participants
n=41 Participants
|
3 Participants
n=39 Participants
|
7 Participants
n=80 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=41 Participants
|
2 Participants
n=39 Participants
|
3 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
2 Participants
n=39 Participants
|
2 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=41 Participants
|
23 Participants
n=39 Participants
|
44 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=41 Participants
|
27 Participants
n=39 Participants
|
47 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=41 Participants
|
27 Participants
n=39 Participants
|
48 Participants
n=80 Participants
|
|
Education
|
16.524 years
STANDARD_DEVIATION 3.080 • n=41 Participants
|
17.704 years
STANDARD_DEVIATION 2.478 • n=39 Participants
|
17.19 years
STANDARD_DEVIATION 2.79 • n=80 Participants
|
|
Time Post-COVID Diagnosis
|
29.714 months
STANDARD_DEVIATION 15.726 • n=41 Participants
|
25.815 months
STANDARD_DEVIATION 12.797 • n=39 Participants
|
27.52 months
STANDARD_DEVIATION 14.13 • n=80 Participants
|
PRIMARY outcome
Timeframe: After study completion, an average of 12 weeksNumber of participants enrolled divided by number of individuals screened
Outcome measures
| Measure |
Overall
n=108 Participants
Recruitment rate was calculated across all participants enrolled
|
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.
|
|---|---|---|
|
Recruitment Rate
|
65 Participants
|
—
|
PRIMARY outcome
Timeframe: After study completion, an average of 12 weeksNumber of participants completing all study procedures divided by number of participants enrolled
Outcome measures
| Measure |
Overall
n=31 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=33 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Retention Rate
|
21 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: After study completion, an average of 12 weeksMeasure of telehealth usability from participant's perspective. Self-report Likert scale of 1 (disagree) to 7 (agree). Higher values represent a better outcome.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Telehealth Usability Questionnaire (TUQ)
|
5.834 units on a scale
Standard Deviation 0.789
|
5.688 units on a scale
Standard Deviation 0.943
|
PRIMARY outcome
Timeframe: After study completion, an average of 12 weeksMeasure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
|
4.381 units on a scale
Standard Deviation 0.636
|
2.676 units on a scale
Standard Deviation 1.040
|
PRIMARY outcome
Timeframe: After study completion, an average of 12 weeksMeasure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Intervention Appropriateness Measure (IAM)
|
4.29 units on a scale
Standard Deviation 0.77
|
2.29 units on a scale
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: After study completion, an average of 12 weeksMeasure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Feasibility of Intervention Measure (FIM)
|
4.55 units on a scale
Standard Deviation 0.48
|
3.69 units on a scale
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Pre-intervention (week 0) and post-intervention (week 12)Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Canadian Occupational Performance Measure (COPM) Performance, Trained Goals
Pre-Testing
|
4.343 units on a scale
Standard Deviation 1.238
|
3.833 units on a scale
Standard Deviation 1.035
|
|
Canadian Occupational Performance Measure (COPM) Performance, Trained Goals
Post-Testing
|
6.745 units on a scale
Standard Deviation 1.398
|
4.685 units on a scale
Standard Deviation 1.449
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Canadian Occupational Performance Measure (COPM) Satisfaction, Trained Goals
Pre-Testing
|
3.198 units on a scale
Standard Deviation 1.302
|
2.787 units on a scale
Standard Deviation 1.200
|
|
Canadian Occupational Performance Measure (COPM) Satisfaction, Trained Goals
Post-Testing
|
7.014 units on a scale
Standard Deviation 1.525
|
4.556 units on a scale
Standard Deviation 1.954
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Time
Pre-Testing
|
10.000 units on a scale
Standard Deviation 4.183
|
9.963 units on a scale
Standard Deviation 3.695
|
|
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Time
Post-Testing
|
10.952 units on a scale
Standard Deviation 3.309
|
11.074 units on a scale
Standard Deviation 2.772
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Errors
Pre-Testing
|
11.429 units on a scale
Standard Deviation 1.165
|
10.704 units on a scale
Standard Deviation 2.478
|
|
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference, Age-Corrected Errors
Post-Testing
|
11.667 units on a scale
Standard Deviation 0.483
|
11.148 units on a scale
Standard Deviation 0.989
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function
Pre-Testing
|
35.486 T-score
Standard Deviation 3.217
|
33.844 T-score
Standard Deviation 3.605
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function
Post-Testing
|
38.343 T-score
Standard Deviation 5.071
|
36.930 T-score
Standard Deviation 5.740
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing Subtest
Pre-Testing
|
0.339 Z-score
Standard Deviation 0.902
|
0.394 Z-score
Standard Deviation 0.759
|
|
Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing Subtest
Post-Testing
|
0.742 Z-score
Standard Deviation 1.226
|
0.707 Z-score
Standard Deviation 0.939
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
CANTAB Spatial Working Memory Subtest
Post-Testing
|
1.080 Z-score
Standard Deviation 1.465
|
0.744 Z-score
Standard Deviation 1.420
|
|
CANTAB Spatial Working Memory Subtest
Pre-Testing
|
0.588 Z-score
Standard Deviation 1.320
|
0.263 Z-score
Standard Deviation 1.410
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
CANTAB Stockings of Cambridge Subtest
Post-Testing
|
0.522 Z-score
Standard Deviation 0.937
|
0.755 Z-score
Standard Deviation 1.263
|
|
CANTAB Stockings of Cambridge Subtest
Pre-Testing
|
0.403 Z-score
Standard Deviation 0.732
|
0.538 Z-score
Standard Deviation 1.313
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
CANTAB Delayed Matching to Sample Subtest
Pre-Testing
|
-0.269 Z-score
Standard Deviation 0.972
|
-0.415 Z-score
Standard Deviation 1.388
|
|
CANTAB Delayed Matching to Sample Subtest
Post-Testing
|
0.004 Z-score
Standard Deviation 1.240
|
0.065 Z-score
Standard Deviation 1.469
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
CANTAB Paired Associates Learning Subtest
Pre-Testing
|
0.736 Z-score
Standard Deviation 0.745
|
0.354 Z-score
Standard Deviation 0.868
|
|
CANTAB Paired Associates Learning Subtest
Post-Testing
|
0.308 Z-score
Standard Deviation 0.758
|
0.532 Z-score
Standard Deviation 0.984
|
SECONDARY outcome
Timeframe: Pre-intervention (week 0) and post-intervention (week 12)Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Canadian Occupational Performance Measure (COPM) Performance, Untrained Goals
Pre-Testing
|
3.667 units on a scale
Standard Deviation 1.713
|
4.259 units on a scale
Standard Deviation 1.810
|
|
Canadian Occupational Performance Measure (COPM) Performance, Untrained Goals
Post-Testing
|
5.476 units on a scale
Standard Deviation 2.482
|
4.889 units on a scale
Standard Deviation 2.118
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Canadian Occupational Performance Measure (COPM) Satisfaction, Untrained Goals
Pre-Testing
|
3.524 units on a scale
Standard Deviation 1.887
|
3.259 units on a scale
Standard Deviation 1.678
|
|
Canadian Occupational Performance Measure (COPM) Satisfaction, Untrained Goals
Post-Testing
|
5.905 units on a scale
Standard Deviation 2.567
|
4.407 units on a scale
Standard Deviation 2.485
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Physical Domain
Pre-Testing
|
35.813 units on a scale
Standard Deviation 17.162
|
38.812 units on a scale
Standard Deviation 13.216
|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Physical Domain
Post-Testing
|
38.492 units on a scale
Standard Deviation 17.475
|
39.660 units on a scale
Standard Deviation 18.923
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Social Domain
Pre-Testing
|
58.662 units on a scale
Standard Deviation 12.033
|
65.500 units on a scale
Standard Deviation 19.123
|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Social Domain
Post-Testing
|
63.333 units on a scale
Standard Deviation 17.357
|
67.067 units on a scale
Standard Deviation 21.683
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Environmental Domain
Pre-Testing
|
61.719 units on a scale
Standard Deviation 12.660
|
65.595 units on a scale
Standard Deviation 11.398
|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Environmental Domain
Post-Testing
|
66.927 units on a scale
Standard Deviation 14.347
|
66.435 units on a scale
Standard Deviation 12.329
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Spiritual Domain
Pre-Testing
|
62.202 units on a scale
Standard Deviation 24.959
|
63.194 units on a scale
Standard Deviation 26.308
|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Spiritual Domain
Post-Testing
|
65.476 units on a scale
Standard Deviation 23.520
|
61.806 units on a scale
Standard Deviation 28.920
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Independence Domain
Pre-Testing
|
41.094 units on a scale
Standard Deviation 21.262
|
38.161 units on a scale
Standard Deviation 16.424
|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Independence Domain
Post-Testing
|
45.685 units on a scale
Standard Deviation 22.540
|
41.030 units on a scale
Standard Deviation 20.595
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Psychological Domain
Pre-Testing
|
50.595 units on a scale
Standard Deviation 14.473
|
52.019 units on a scale
Standard Deviation 14.138
|
|
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) - Psychological Domain
Post-Testing
|
57.500 units on a scale
Standard Deviation 14.822
|
53.472 units on a scale
Standard Deviation 16.299
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall
n=21 Participants
Recruitment rate was calculated across all participants enrolled
|
Inactive Control Group
n=27 Participants
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
Cognitive Failures Questionnaires Total Score
Pre-Testing
|
58.667 units on a scale
Standard Deviation 7.876
|
60.889 units on a scale
Standard Deviation 11.673
|
|
Cognitive Failures Questionnaires Total Score
Post-Testing
|
54.143 units on a scale
Standard Deviation 12.733
|
57.889 units on a scale
Standard Deviation 15.167
|
Adverse Events
Cognitive Orientation to Daily Occupational Performance (CO-OP)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Inactive Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Orientation to Daily Occupational Performance (CO-OP)
n=21 participants at risk
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.
|
Inactive Control Group
n=27 participants at risk
Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
|
|---|---|---|
|
General disorders
ER Visit
|
4.8%
1/21 • Number of events 1 • Through study completion, up to 12 weeks
|
0.00%
0/27 • Through study completion, up to 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place