Cognitive Rehabilitation in Post-COVID-19 Syndrome

NCT06136871 | Completed Results DMC

• 2 other identifiers: 2096158R21HD112373-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Post-COVID-19 Syndrome

Keywords

covid-19; metacognition; cognition; telehealth; activities of daily living

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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 Outcomes (17)

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

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

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

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

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

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

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

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

• CANTAB Spatial Working Memory Subtest

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

Study Arms (2)

Cognitive Orientation to daily Occupational Performance (CO-OP)

EXPERIMENTAL

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

Inactive Control Group

OTHER

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

Interventions

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.

Cognitive Orientation to daily Occupational Performance (CO-OP)

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.

Inactive Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Missouri Department of Occupational Therapy

Columbia, Missouri, 65211, United States

Location

Related Publications (6)

• 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.

  PMID: 25416738 BACKGROUND

• 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.

  PMID: 18030634 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 16084827 BACKGROUND

• 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.

  PMID: 19892074 BACKGROUND

• 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.

  PMID: 26943113 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Anna Boone, PhD
• Organization: University of Missouri

booneae@umsystem.edu

573-882-7023

Study Officials

• Anna E Boone, PhD, OTR/L

  University of Missouri Occupational Therapy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes assessors will be blinded to participant study group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Occupational Therapy

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: February 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)