Cognitive Rehabilitation for Long COVID

NCT05676047 | Completed

• 1 other identifier: 15621
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are comparing two different methods for helping adults with Long Coronavirus (COVID) also known as Post-Coronavirus Syndrome or Post-Coronavirus Condition manage everyday cognitive challenges. Cognitive rehabilitation is a type of therapy that helps people who have challenges with everyday thinking because of a brain injury. One of the investigators on this project along with colleagues in the United States (US) have developed a streamlined version of cognitive rehabilitation therapy for mild traumatic brain injury (mTBI) that can be completed in person or virtually and takes place over a 3-week period. The therapy was originally designed for adults with mTBI. The investigators want to know if it can also be used to treat people with cognitive complaints from Long COVID. The investigators will provide education materials only to one group and individual cognitive rehabilitation delivered by a trained Speech Language Pathologist (SLP) or Occupational Therapist (OT) to the other group. The investigators want to find out whether the individual therapy is as feasible and accessible than the usual educational material. What the investigators learn in this study may help treat day-to-day thinking challenges in Long COVID.

Conditions

Long COVID

Keywords

Cognitive Rehabilitation; Cognitive Functioning

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

  The primary outcome is the rate of recruitment, average 5 per month. The primary outcome is the rate of recruitment and retention rate reported as the total number of participants recruited and retained.

  9 months

Secondary Outcomes (3)

• Acceptability of the Intervention

  Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

• Acceptability of the Appropriateness

  Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

• Acceptability of the Feasibility

  Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment

Study Arms (2)

Therapy Group

EXPERIMENTAL

The Therapy Group will receive 6-10 individual sessions of 30-60 minutes each, delivered by a trained Occupational Therapist or Speech-Language Pathologist. The therapy will be delivered over a 4-week timeframe, with the total number of sessions per participant depending on the number of sessions needed to achieve their treatment targets. Each participant in the Therapy Group will identify three cognitive targets for treatment. Progress in reaching those targets will be documented using Goal Attainment Scaling (GAS)

Behavioral: Cognitive Rehabilitation

Educational Group

ACTIVE COMPARATOR

The Education group will receive information about self-management of cognitive symptoms at the time of randomization, a common alternative for adults with Long COVID cognitive symptoms who do not receive Individual Therapy.

Other: Education

Interventions

Cognitive Rehabilitation BEHAVIORAL

A strategy-focused intervention aimed at improving everyday cognitive function, structured to maximize treatment dose over a short time period. The shorter time period of the treatment therapy is relative to the one and only current randomized controlled trial of cognitive rehabilitation for military mTBI, the Study of Cognitive Rehabilitation Effectiveness (SCORE).

Therapy Group

Education OTHER

The Education group will receive information about self-management of cognitive symptoms at the time of randomization, a common alternative for adults with Long COVID cognitive symptoms who do not receive Individual Therapy.

Educational Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a community-dwelling adults
• Is age 18 years or older
• Self-identifies as a fluent English speaker
• Have a history of COVID symptoms as listed on the Government of Canada COVID information website, a positive antigen or polymerase chain reaction (PCR) test, or both
• Have cognitive symptoms that have persisted a minimum of 12 weeks after contracting COVID
• Have cognitive symptoms attributable to COVID and not to other intervening diagnoses associated with cognitive dysfunction (e.g., psychosis, concussion), or medications with negative effects on cognitive function
• Have no previous history of a diagnosis of a neurological disorder affecting thinking (e.g., dementia)
• Are able to participate in 3 one-hour sessions per week for 4-6 weeks
• Are not in active behavioural treatment for a substance-use or mental-health disorder, or in cognitive rehabilitation provided by a registered health professional (e.g., speech-language pathologist or occupational therapist)
• Can access an electronic device with internet access and capability for Zoom videoconferencing

You may not qualify if:

• A score of less than 20 on the Montreal Cognitive Assessment (MoCA), which indicates a risk for dementia.
• Cannot identify at least 3 problems on the Common Cognitive Complaints after Concussion Questionnaire (C4), as there would be insufficient areas for intervention.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, Canada

Location

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Related Links

• Viral Neuro Exploration (VINEx), COVID Long Haulers Support Group Canada, Neurological Health Charities Canada. Report on Long COVID Impact Survey. 2021
• Office for National Statistics. Prevalence of ongoing symptoms following coronavirus (COVID-19) infection in the United Kingdom
• How does COVID-19 affect the brain? A troubling picture emerges.

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Cognitive Training; Educational Status

Condition Hierarchy (Ancestors)

COVID-19; 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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Jackie Bosch, PhD

  McMaster University School of Rehabilitation Science

  PRINCIPAL INVESTIGATOR

• Lyn Turkstra, PhD

  McMaster University School of Rehabilitation Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will be blinded to randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either the Therapy (n=50) or Education Group (n=50). At the conclusion of therapy (for the Therapy Group) or after three weeks (for the Education Group), participants will be re-administered the outcome measures. The outcome measures using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) will then be compared during data analysis between the two groups.

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 9, 2023
• Study Start: May 1, 2023
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)