Self-Management Interventions for Long COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-23

Study Completion Date

2025-12-01

Brief Summary

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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.

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Detailed Description

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After a COVID-19 infection, more than 75% of patients report ongoing somatic, cognitive, and psychiatric symptoms. At this time, research is needed to help develop treatments that limit the impact of these symptoms on people who have had COVID-19. The present study investigates the feasibility and efficacy of two group-based interventions in a single-centre, 3-arm, pragmatic RCT comprising (i) an Education Intervention Group arm, (ii) a Mindfulness Skills Intervention Group arm, and (iii) a No-Treatment Control Group arm. Phase 1 is a pilot RCT and will employ a mixed methods design with qualitative post-treatment interviews in a subset of participants in the Education Intervention Group arm only. Phase 2 is a full-scale, quantitative-only RCT, with refinements and power analysis based on the results of Phase 1. Sessions of both groups are delivered by licensed therapists and clinicians. Sessions last 1.5 hours per week for 8 weeks, with 10-15 patients/group in an online format. The Education group participants will learn about the nature of Long-COVID symptoms and discuss strategies for self-care/self-management of symptoms in recovery. The Mindfulness Skills Intervention group participants will receive an introduction to some basic mindfulness skills and practice strategies such as Mindfulness of Breath, Body, Sounds, Thoughts, and Choiceless Awareness.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-Centre, multi-arm, pragmatic RCT

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Education and Strategies Intervention

Intervention Type BEHAVIORAL

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 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.

Group Type ACTIVE_COMPARATOR

Mindfulness Skills Intervention

Intervention Type BEHAVIORAL

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.

No-Treatment Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No