Recruiting

Self-Management

Sponsor:

Toronto Rehabilitation Institute

Code:

NCT05268523

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Education and Strategies Intervention

Mindfulness Skills Intervention

Study Details

Brief summary:

The purpose of this study is to investigate and compare the feasibility and efficacy of two group-based interventions (education vs. mindfulness) to help self-manage Long-COVID symptoms.

Conditions

COVID-19

Study ID

NCT05268523

Start date

Nov 23, 2021

Status verified date

Nov, 2024

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Clinically diagnosed Long-COVID plus PCR positivity with and without hospitalization
  • 3-12 months post-diagnosis of COVID-19
  • >2 self-reported persisting symptoms in >1 mood, cognitive and/or somatic symptom domain
  • Age >18
  • English speaking
  • Private access to computer/internet

Exclusion Criteria:

  • Acute ventilator support
  • Diagnosed dementia
  • Past/present history of psychotic illness or mania and, because of potential overlap in symptoms, diagnosis of chronic fatigue syndrome, fibromyalgia, chronic lyme disease or traumatic brain injury
  • Long-COVID symptom severity (i.e., physical, cognitive, emotional symptoms) at a level that would significantly interfere with attendance/adherence to the intervention protocol

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Education and Strategies Intervention Group

Participants will use a videoconferencing system to participate in the Education and Strategies Intervention composed of 1 session per week (1.5 hrs/session) over the course of 8 weeks.

active comparator: Mindfulness Skills Intervention Group

Participants will use a videoconferencing system to participate in the Mindfulness Skills Intervention composed of 1 session per week (1.5 hrs/session) over the course of 8 weeks.

no intervention: No-Treatment Control Group

Participants adhere to the standard of care (no study treatment) for 8 weeks.

Interventions

Education and Strategies Intervention

Sessions will be led by registered therapists and clinicians in the fields of psychology, rheumatology, cardiology and neurology. The sessions will be comprised of educational presentations on the nature of persisting symptoms after COVID-19 and associated recommendations for self-management.

Mindfulness Skills Intervention

The Mindfulness Skills Intervention is an 8-week program designed to provide an introduction to some basic mindfulness skills. Each session begins with a brief breath focus practice followed by discussion of the experience and sharing/discussion of the previous week including participants' experiences. Each session also includes some didactics, and a new, related mindfulness skill is introduced and practiced, followed by another discussion.

Primary outcome measure

  • Change in Brief-COPE [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in LOT [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Kessler Psychological Distress Scale (K10) [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in SSS-8 [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Perceived Medical Condition Self-Management Scale [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in the Depression, Anxiety and Stress Scale [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Quality of Life Enjoyment and Satisfaction Questionnaire [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Adapted Illness Intrusiveness Rating [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in self-reported physician visits [ Time Frame: Baseline and 1-week post-intervention. ]
  • Change in Self-efficacy [ Time Frame: Baseline and 1-week post-intervention. ]

Central Contacts and Locations

Central contacts

Julia Rybkina, MSc

416-597-3422julia.rybkina@uhn.ca

Nithin Jacob, MSc

416-597-3422helpscovid@uhn.ca

Locations

Toronto Rehabilitation Institute

Recruiting

Toronto, Ontario, Canada, M5G 2A2

More Information

Sponsor

Toronto Rehabilitation Institute

Last update posted

Nov 25, 2024

Last verified

Nov, 2024

Keywords

  • Long-term effects
  • Self-management
  • Group therapy
  • Telerehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Toronto Rehabilitation Institute on 2024-11-25.