Mindfulness-Based Stress Reduction Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia (MBSR-LCP)

The Washington University

Status: Terminated

Conditions: COVID-19

Treatments: Behavioral: Lifestyle Intervention; Behavioral: Mindfulness-Based Stress Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT06789952

202206182

Details and patient eligibility

About

Olfactory dysfunction (OD) is a defining symptom of COVID-19 infection. As the number of total, confirmed novel coronavirus SARS-CoV-2 (COVID-19) cases exceeds 45 million in the United States, it is estimated that up to 85% of infected patients will experience at least some olfactory dysfunction.

Therefore, we propose a Pilot single-site clinical trial to explore the efficacy of MBSR for Covid-19-related smell distortion (parosmia)

Full description

The perception of distorted smell in the presence of a familiar odor is referred to as parosmia. Parosmia can severely impair appetite and quality of life as familiar smells can trigger a foul smell. Parosmia is increasingly recognized as a long COVID symptom. Intranasal and oral corticosteroids, theophylline, Vitamin A, and omega-3 have all been proposed as treatment options for post-viral OD. Budesonide steroid irrigation paired with olfactory training, another avenure for treating olfactory loss, has shown some benefit compared with olfactory training alone. However, these treatments have demonstrated limited efficacy for patients with parosmia.

Mindfulness-based stress reduction (MBSR) is a psychological therapeutic intervention that emphasizes the focused, non-judgmental awareness of present-moment experiences without efforts being made to alter or avoid them. It is a practice that is embedded in mind/body and integrative medicine to cultivate psychological and emotional resilience. MBSR improves anxiety, depression, insomnia, and other psychological outcomes in clinical trials. Although MBSR is one of the most widely practiced and extensively studied meditation programs in the world, its mechanism of benefit for patients with parosmia has not yet been assessed.

In this phase II trial, patients will be allocated 1:1 to receive either a mindfulness-based stress reduction course or a lifestyle management course. The courses will meet virtually once per week for 8 consecutive weeks as well as a one-time 4 hour virtual retreat.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults between the ages of 18 to 65 years
• Reside within the continental United States
• Ability to engage in virtual group sessions for 2 hours either Tuesday or Wednesday evenings for 8 consecutive weeks and the 1/2 day Weekend Retreat.
• Clinically diagnosed or subjective parosmia of at least 3 months duration after COVID- 19 infection

Exclusion criteria

• Clinically diagnosed olfactory dysfunction secondary to non-COVID-19 viral infection, genetic abnormalities, congenital dysfunction, trauma, nasal polyps, or neurodegenerative disorders.
• Availability less than 4 months from time of enrollment
• Residency outside the continental United States
• History of substance abuse, PTSD, thoughts of self-harm, or other active poorly controlled psychiatric or psychological conditions
• Sinus surgery in the 6 weeks prior to enrollment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Mindfulness-Based Stress Reduction

Experimental group

Description:

Participants randomized to the MBSR arm will complete eight weekly 2.0 to 2.5 hour classes. There will be a 30-minute Introduction session immediately prior to the first MBSR session. There will also be a 4-hour retreat the weekend prior to the Week 7 session. The subjects will be asked to practice formal mindfulness practices for 30 minutes per day.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Lifestyle Intervention

Active Comparator group

Description:

Participants randomized to the Lifestyle arm will complete eight weekly 2.0 to 2.5 hour classes. There will be a 30-minute Introduction session immediately prior to the first Lifestyle session. There will also be a 4-hour retreat the weekend prior to the Week 8 session. The subjects will be asked to practice formal lifestyle practices for 30 minutes per day.

Treatment:

Behavioral: Lifestyle Intervention