Cognitive Rehabilitation in Post-COVID-19 Syndrome

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06136871

Collaborator

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

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-COVID-19 Syndrome	Behavioral: CO-OP Procedures Behavioral: Inactive Control Group	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Outcomes Assessor)

Masking Description:

All outcomes assessors will be blinded to participant study group assignment.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: CO-OP Procedures 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.
Active Comparator: 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.	Behavioral: Inactive Control Group 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: CO-OP Procedures

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.

Active Comparator: 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.

Behavioral: Inactive Control Group

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.

Outcome Measures

Primary Outcome Measures

Feasibility measures [After study completion, an average of 12 weeks]
Recruitment rate, retention rate
Telehealth Usability Questionnaire (TUQ) [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)
Acceptability of Intervention Measure (AIM) [After study completion, an average of 12 weeks]
Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Intervention Appropriateness Measure (IAM) [After study completion, an average of 12 weeks]
Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Feasibility of Intervention Measure (FIM) [After study completion, an average of 12 weeks]
Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Canadian Occupational Performance Measure (COPM) [Pre-intervention (week 0), week 2, week 4, week 6, week 8, and post-intervention (week 12)]
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

Secondary Outcome Measures

Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference [Pre-intervention (week 0) and post-intervention (week 12)]
Objective measure of inhibition and cognitive flexibility. Consists of 4 conditions (color naming, word reading, inhibition, and inhibition/switching). Therapist records client-corrected errors, noncorrected errors, and total time required for each domain. Increased errors and time indicate potential challenges with inhibition and cognitive flexibility.
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function [Pre-intervention (week 0) and post-intervention (week 12)]
Self-report measure of cognition. Maximum=5, minimum=1. Higher scores indicate fewer perceived cognitive deficits.
World Health Organization Quality of Life Assessment Instrument (WHOQOL-100) [Pre-intervention (week 0) and post-intervention (week 12)]
Self-report measure of quality of life. Maximum=5, minimum=1. Higher scores indicate greater perceived quality of life.
Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing Subtest [Pre-intervention (week 0) and post-intervention (week 12)]
Objective measure of sustained attention. Other outcomes include latency (speed of response), probability of false alarms, and sensitivity.
CANTAB Spatial Working Memory Subtest [Pre-intervention (week 0) and post-intervention (week 12)]
Objective measure of working memory and strategy.
CANTAB Stockings of Cambridge Subtest [Pre-intervention (week 0) and post-intervention (week 12)]
Objective measure of planning and executive function. Other outcomes include problem-solving ability and time required to complete task.
CANTAB Delayed Matching to Sample Subtest [Pre-intervention (week 0) and post-intervention (week 12)]
Objective measure of short-term visual recognition memory and attention. Other outcomes include latency (speed of response), the number of correct patterns selected and a statistical measure giving the probability of an error after a correct or incorrect response.
CANTAB Paired Associates Learning Subtest [Pre-intervention (week 0) and post-intervention (week 12)]
Objective measure of visual episodic memory. Other outcomes include the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)