Self-Management Interventions for Long COVID

Overseen By Nithin Jacob, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Toronto Rehabilitation Institute

Disqualifiers: Dementia, Psychotic illness, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how two different group-based programs can help people manage symptoms of Long COVID. One group will learn through educational sessions (Education and Strategies Intervention), while another will practice mindfulness techniques (Mindfulness Skills Intervention). Participants will meet online once a week for eight weeks. The trial seeks individuals who have experienced Long COVID for 3 to 12 months and are dealing with at least two ongoing symptoms affecting mood, thinking, or body functions.

As an unphased trial, this study offers a unique opportunity to contribute to understanding effective management strategies for Long COVID symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Education and Strategies Intervention and the Mindfulness Skills Intervention are safe for people with Long COVID. Studies have found that these methods help manage symptoms without any known side effects. The Education and Strategies Intervention teaches individuals to handle their symptoms through learning and self-care techniques. Similarly, mindfulness-based methods reduce anxiety and depression in Long COVID patients. No major negative effects have been reported for either approach, making them well-tolerated options for managing symptoms effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they offer new ways to manage Long COVID symptoms through self-management techniques. Traditional treatments often focus on symptom relief with medications, but these interventions emphasize active participation by patients. The Education and Strategies Intervention provides structured guidance via weekly videoconferencing sessions, helping participants develop personalized strategies to cope with their symptoms. Meanwhile, the Mindfulness Skills Intervention incorporates mindfulness practices to improve mental well-being, potentially reducing stress and enhancing overall quality of life. Both approaches empower patients to take control of their health, offering promising alternatives to conventional treatments.

What evidence suggests that this trial's treatments could be effective for Long COVID?

Research has shown that both education and mindfulness activities can help manage Long COVID symptoms. In this trial, participants in the Education and Strategies Intervention Group will learn about the condition and use specific strategies. Studies indicate these strategies can boost confidence in handling symptoms, improve quality of life, and reduce doctor visits. Meanwhile, participants in the Mindfulness Skills Intervention Group will engage in mindfulness activities, which have been found to lower anxiety and depression in people with Long COVID. These activities also help reduce tiredness and improve sleep. Both methods aim to equip individuals with tools to better manage their symptoms, enhancing overall well-being. ^{1 2 3 4 6}

Who Is on the Research Team?

Robin Green, PhD

Principal Investigator

KITE- Toronto Rehabilitation Institute, University Health Network

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been clinically diagnosed with Long COVID-19, confirmed by a PCR test, and are experiencing persistent symptoms in mood, cognitive or somatic areas. Participants must speak English and have private internet access to join.

Inclusion Criteria

Clinically diagnosed Long-COVID plus PCR positivity with and without hospitalization

3-12 months post-diagnosis of COVID-19

English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an Education Intervention or a Mindfulness Skills Intervention for Long-COVID symptoms

8 weeks

8 sessions (online, 1.5 hours each)

Follow-up

Participants are monitored for changes in coping, self-efficacy, psychological distress, and other outcomes post-intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Education and Strategies Intervention
• Mindfulness Skills Intervention

Trial Overview

The study compares two group-based self-management interventions for Long COVID: one focuses on mindfulness skills while the other provides education and strategies to manage symptoms.

How Is the Trial Designed?

Group I: Education and Strategies Intervention Group Experimental Treatment 1 Intervention

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 II: No-Treatment Control Group Active Control 1 Intervention

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

Group III: Mindfulness Skills Intervention Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Toronto Rehabilitation Institute

Lead Sponsor

Trials

55

Recruited

6,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

Mindfulness-based cognitive therapy (MBCT) is highly valued by participants, with many describing it as 'life changing,' but about one-third of graduates still experience depression relapse within a year after completing the course.

Participants expressed a strong desire for additional support after MBCT, suggesting that a maintenance program could help them sustain mindfulness practices and reduce the risk of relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. Siwik, CJ., Adler, SR., Moran, PJ., et al.[2023]

A review of 20 studies identified key barriers to adherence to Mindfulness-Based Cognitive Therapy (MBCT) for patients with chronic conditions, including practical factors like time commitments and motivation levels.

Facilitators for adherence included strong connections with group members and the credibility of the intervention, suggesting that addressing these factors could improve patient engagement and outcomes in MBCT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the barriers and facilitators to adherence to mindfulness-based cognitive therapy for those with chronic conditions. Marks, E., Moghaddam, N., De Boos, D., et al.[2023]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

Mindfulness-based cognitive therapy (MBCT) is as effective as maintenance antidepressant medication in preventing relapse in patients with major depressive disorder who have achieved remission, based on a study of 160 patients followed for 18 months.

For patients with unstable remission, both MBCT and maintenance treatment significantly reduced the risk of relapse by 73% compared to placebo, emphasizing the need for ongoing treatment in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Segal, ZV., Bieling, P., Young, T., et al.[2021]

Mindfulness-Based Stress Reduction (MBSR) significantly decreased anxiety levels in healthcare graduate students after 8 weeks of training, with improvements maintained at 3 weeks post-course.

MBSR also increased empathy among students at the end of the program, although this effect did not persist at the 3-week follow-up, and no significant changes in burnout were observed between the intervention and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. Barbosa, P., Raymond, G., Zlotnick, C., et al.[2013]

The mindfulness-based stress reduction (MBSR) training program significantly decreased staff stress and increased mindfulness in a high-acuity psychiatric inpatient unit over a 2-month period after an 8-day training.

There was a positive trend in patient and staff safety, evidenced by fewer staff call-ins, reduced need for one-on-one staffing, and decreased use of restraints following the MBSR training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the culture of safety on a high-acuity inpatient child/adolescent psychiatric unit by mindfulness-based stress reduction training of staff. Hallman, IS., O'Connor, N., Hasenau, S., et al.[2014]

Mindfulness Based Stress Reduction (MBSR) courses delivered online during the COVID-19 pandemic were found to be feasible and acceptable, with course completion rates similar to in-person sessions (84.1% vs 67.6%).

Participants reported significant benefits from the online MBSR, including improved stress coping, quality of life, and morale, suggesting that online formats can effectively expand access to mental health resources during challenging times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction Live Online During the COVID-19 Pandemic: A Mixed Methods Feasibility Study. Riley, TD., Roy, S., Parascando, JA., et al.[2022]

The Journeys to Wellness trial successfully adapted the standard 8-week mindfulness-based stress reduction (MBSR) program into a workshop and teleconference format (tMBSR) for 63 kidney transplant candidates, showing high attendance and satisfaction rates among participants.

Participants in the tMBSR group reported significantly higher expectations of the intervention's usefulness for managing their health (83%) compared to the tSupport group (43%), indicating a positive reception and potential efficacy of the mindfulness training for improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. Reilly-Spong, M., Reibel, D., Pearson, T., et al.[2022]

Mindfulness-Based Cognitive Therapy for Preventing Suicide Behavior (MBCT-S) did not significantly delay the time to a suicide event compared to treatment-as-usual (eTAU), but it did reduce the total number of suicide events from 92 in eTAU to 56 in MBCT-S, indicating a potential benefit in preventing suicide occurrences.

MBCT-S also showed promising results by significantly reducing the proportion of participants attempting suicide and decreasing the number of psychiatric hospitalizations, suggesting it may enhance overall safety and efficacy in suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans: A Randomized Clinical Trial. Interian, A., Chesin, MS., Stanley, B., et al.[2022]

Military sexual trauma (MST) significantly impacts the mental health of Veterans, with 22% of women and 1% of men reporting experiences of sexual assault or harassment during service, leading to increased risks of emotional dysregulation and suicide.

Mindfulness-based stress reduction (MBSR) is proposed as an effective intervention for Veterans affected by MST, as it can help improve emotion regulation and is supported by evidence for treating conditions like depression and PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for veterans exposed to military sexual trauma: rationale and implementation considerations. Gallegos, AM., Cross, W., Pigeon, WR.[2017]

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