Cognitive Rehabilitation in Post-COVID-19 Syndrome

University of Missouri (MU)

Status: Completed

Conditions: Post-COVID-19 Syndrome

Treatments: Behavioral: Inactive Control Group; Behavioral: CO-OP Procedures

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06136871

R21HD112373-01 (U.S. NIH Grant/Contract)

2096158

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Cognitive Orientation to daily Occupational Performance (CO-OP)

Experimental group

Description:

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.

Treatment:

Behavioral: CO-OP Procedures

Inactive Control Group

Other group

Description:

Subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.

Treatment:

Behavioral: Inactive Control Group