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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
All outcomes assessors will be blinded to participant study group assignment.

Arm Groups

ArmDescriptionAssigned Intervention
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.
Other
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.

Recruiting Locations

University of Missouri Department of Occupational Therapy
Columbia, Missouri 65211
Contact:
Anna E Boone, PhD, OTR/L
573-882-7023
booneae@umsystem.edu

More Details

NCT ID
NCT06136871
Status
Recruiting
Sponsor
University of Missouri-Columbia

Study Contact

Anna E Boone, PhD, OTR/L
573-882-7023
booneae@umsystem.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.