← Back to Search

Therapy Group for COVID-19 (STAR-C3 Trial)

Q: What are the eligibility requirements for participating in this clinical trial?

<p>This medical trial seeks 100 individuals with <a href="https://www.withpower.com/clinical-trials/covid">COVID</a>-19 aged between 18 and 100. Eligible participants must fulfill the following criteria: be a community dwelling adult, demonstrate fluency in English, have experienced cognitive deficits for at least 12 weeks after contracting <a href="https://www.withpower.com/clinical-trials/coronavirus">coronavirus</a>, lack any prior diagnosis of neurological disorder impacting cognition, commit to attending 3 1 hour sessions per week over 4-6 weeks, not currently receive behavioural treatment or rehabilitation from a registered health professional, possess an electronic device capable of video conferencing via Zoom as well as internet access.</p>

N/A

Recruiting

Led By Jackie Bosch, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 no previous history of a diagnosis of a neurological disorder affecting thinking (e.g., dementia)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

STAR-C3 Trial Summary

This trial compares two methods to help adults with Long COVID manage everyday cognitive challenges: education materials vs. individual therapy. Can it help treat day-to-day thinking challenges in Long COVID?

Who is the study for?

This trial is for adults over 18 who've had COVID-19 and are experiencing lasting cognitive issues for at least 12 weeks. Participants must speak English fluently, have no history of neurological disorders like dementia, not be in active treatment for substance-use or mental-health disorders, and can attend virtual sessions.Check my eligibility

What is being tested?

The study compares two approaches to help with thinking challenges due to Long COVID: one group receives educational materials only, while the other gets individual therapy from a Speech Language Pathologist or Occupational Therapist over a period of 3-6 weeks.See study design

What are the potential side effects?

Since this trial involves education and cognitive rehabilitation rather than medication, traditional side effects are not expected. However, participants may experience fatigue or emotional distress during therapy.

STAR-C3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had COVID symptoms or a positive COVID test.

Select...

I have never been diagnosed with a brain disorder affecting my thinking.

Select...

I am 18 years old or older.

STAR-C3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recruitment Rate

Secondary outcome measures

Acceptability of the Appropriateness

Acceptability of the Feasibility

Acceptability of the Intervention

STAR-C3 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Therapy GroupExperimental Treatment1 Intervention

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)

Group II: Educational GroupActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Rehabilitation

2009

N/A

~700

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,453,467 Total Patients Enrolled

33 Trials studying COVID-19

362,224 Patients Enrolled for COVID-19

McMaster UniversityLead Sponsor

884 Previous Clinical Trials

2,598,216 Total Patients Enrolled

20 Trials studying COVID-19

148,807 Patients Enrolled for COVID-19

Jackie Bosch, PhDPrincipal InvestigatorMcMaster University School of Rehabilitation Science

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings in this medical trial for enrolled participants?

"Affirmative. Clinicaltrials.gov's records confirm that this clinical trial is in the process of recruiting candidates, having been posted on May 1st 2023 and updated on December 12th 2023. One hundred patients are currently being accepted at a single medical site."

Answered by AI

Are individuals aged 20 and over being recruited for this experiment?

"Individuals who meet the cut-off age of 18 to 100 may qualify for this trial. Currently, there are 11 studies in progress specifically directed towards minors and 127 targeting adults over 65 years old."

Answered by AI

What is the limit for participant enrollment in this research study?

"Affirmative. Clinicaltrials.gov data validates that recruitment is still open for this investigation, which was originally posted on May 1st 2023 and updated as recently as December 12th 2023. The target number of enrollees is 100 at a single location."

Answered by AI

What are the eligibility requirements for participating in this clinical trial?

"This medical trial seeks 100 individuals with COVID-19 aged between 18 and 100. Eligible participants must fulfill the following criteria: be a community dwelling adult, demonstrate fluency in English, have experienced cognitive deficits for at least 12 weeks after contracting coronavirus, lack any prior diagnosis of neurological disorder impacting cognition, commit to attending 3 1 hour sessions per week over 4-6 weeks, not currently receive behavioural treatment or rehabilitation from a registered health professional, possess an electronic device capable of video conferencing via Zoom as well as internet access."

Answered by AI

Recent research and studies

eClinicalMedicineJournal

Characterizing Long COVID in an International Cohort: 7 Months of Symptoms and Their Impact

Davis, Hannah E., Gina S. Assaf, Lisa McCorkell, Hannah Wei, Ryan J. Low, Yochai Re'em, Signe Redfield, Jared P. Austin, and Athena Akrami. 2021. “Characterizing Long COVID in an International Cohort: 7 Months of Symptoms and Their Impact”. Eclinicalmedicine. Elsevier BV. doi:10.1016/j.eclinm.2021.101019.

The Clinical NeuropsychologistJournal

Normative Data for the Neurobehavioral Symptom Inventory (NSI) and Post-concussion Symptom Profiles Among TBI, PTSD, and Nonclinical Samples

Soble, Jason R., Marc A. Silva, Rodney D. Vanderploeg, Glenn Curtiss, Heather G. Belanger, Alison J. Donnell, and Steven G. Scott. 2014. “Normative Data for the Neurobehavioral Symptom Inventory (NSI) and Post-concussion Symptom Profiles Among TBI, PTSD, and Nonclinical Samples”. The Clinical Neuropsychologist. Informa UK Limited. doi:10.1080/13854046.2014.894576.

BmjJournal

CONSORT 2010 Statement: Extension to Randomised Pilot and Feasibility Trials

Eldridge, Sandra M, Claire L Chan, Michael J Campbell, Christine M Bond, Sally Hopewell, Lehana Thabane, and Gillian A Lancaster. 2016. “CONSORT 2010 Statement: Extension to Randomised Pilot and Feasibility Trials”. Bmj. BMJ. doi:10.1136/bmj.i5239.

Journal of Biomedical InformaticsJournal