Clinical trial NCT06136871: Cognitive Rehabilitation in Post-COVID-19 Syndrome
Official title: Cognitive Strategy Training in Post-COVID-19 Syndrome: a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-COVID-19 Syndrome
Keywords: covid-19
metacognition
cognition
telehealth
activities of daily living
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-11-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility measures
timeFrame: After study completion, an average of 12 weeks
measure: Telehealth Usability Questionnaire (TUQ)
timeFrame: After study completion, an average of 12 weeks
measure: Acceptability of Intervention Measure (AIM)
timeFrame: After study completion, an average of 12 weeks
measure: Intervention Appropriateness Measure (IAM)
timeFrame: After study completion, an average of 12 weeks
measure: Feasibility of Intervention Measure (FIM)
timeFrame: After study completion, an average of 12 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Pre-intervention (week 0), week 2, week 4, week 6, week 8, and post-intervention (week 12)
Secondary outcomes:
measure: Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: World Health Organization Quality of Life Assessment Instrument (WHOQOL-100)
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB) Rapid Visual Information Processing Subtest
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: CANTAB Spatial Working Memory Subtest
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: CANTAB Stockings of Cambridge Subtest
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: CANTAB Delayed Matching to Sample Subtest
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
measure: CANTAB Paired Associates Learning Subtest
timeFrame: Pre-intervention (week 0) and post-intervention (week 12)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Department of Occupational Therapy
state: Missouri
Study officials:
affiliation: University of Missouri Occupational Therapy
name: Anna E Boone, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: Haskins EC, Cicerone KD, Trexler LE. Cognitive rehabilitation manual: Translating evidence-based recommendations into practice. ACRM Publishing; 2012.
citation: 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.
citation: 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.
citation: 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.