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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Education and Strategies Intervention, Educational Support, Strategic Learning Intervention, Mindfulness Skills Intervention, Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Cognitive Therapy (MBCT), Dialectical Behavior Therapy (DBT), Acceptance and Commitment Therapy (ACT) for Long COVID?

Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR) have shown effectiveness in reducing psychological distress and stress, which may be beneficial for managing Long COVID symptoms. MBCT is effective in reducing depression relapse, and MBSR helps in stress reduction and emotion management, which could support Long COVID patients in coping with their condition. ^{1 2 3 4 5}

Is mindfulness-based stress reduction (MBSR) safe for humans?

Mindfulness-based stress reduction (MBSR) is considered safe for humans and has been used effectively as a self-management strategy for conditions like depression and post-traumatic stress disorder. It is a non-invasive approach that focuses on mind and body practices to help manage stress and emotions. ^{3 5 6 7 8}

How is the Self-Management Interventions for Long COVID treatment different from other treatments?

This treatment is unique because it combines education and mindfulness-based interventions, like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), which focus on self-management and stress reduction rather than medication. These approaches have been shown to help with stress and psychological distress, and can be delivered online, making them more accessible to people with mobility issues or those who prefer remote options. ^{1 2 9 10 11}

What is the purpose of this trial?

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.

Research Team

Robin Green, PhD

Principal Investigator

KITE- Toronto Rehabilitation Institute, University Health Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Preventing Depression Relapse: A Qualitative Study on the Need for Additional Structured Support Following Mindfulness-Based Cognitive Therapy. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Cognitive Therapy for Preventing Suicide in Military Veterans: A Randomized Clinical Trial. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for veterans exposed to military sexual trauma: rationale and implementation considerations. [2017]

7. England 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. [2018]

8. England 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. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction Live Online During the COVID-19 Pandemic: A Mixed Methods Feasibility Study. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. [2022]