Self-Management Interventions for Long COVID-19

Toronto Rehabilitation Institute

Status: Enrolling

Conditions: COVID-19

Treatments: Behavioral: Mindfulness Skills Intervention; Behavioral: Education and Strategies Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05268523

21-5038

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 3 patient groups

Education and Strategies Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Education and Strategies Intervention

Mindfulness Skills Intervention Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mindfulness Skills Intervention

No-Treatment Control Group

No Intervention group

Description:

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