Olfactory dysfunction (OD) is a defining symptom of COVID-19 infection. As the number oftotal, confirmed novel coronavirus SARS-CoV-2 (COVID-19) cases exceeds 45 million in theUnited States, it is estimated that up to 85% of infected patients will experience atleast some olfactory dysfunction.Therefore, we propose a Pilot single-site clinical trial to explore the efficacy of MBSRfor Covid-19-related smell distortion (parosmia)
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.
Behavioral: 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, it combines formal and informal practices of mindfulness.
The formal practices include body scanning, gentle hatha yoga - movements, sitting
meditation and walking, meditation. Informal practices include mindfulness of daily
activities, such as eating, driving, washing dishes, showering, etc. A variety of other
exercises will be used as a support for developing proficiency in the practice of
mindfulness. This class places strong emphasis on experiential learning. Each session
will include:
- guided instruction while engaging in practices of mindfulness
- opportunity to reflect on experiences and ask questions
- discussion of topics related to the practice of mindfulness as a strategy for
reducing stress
Behavioral: Lifestyle Intervention
The lifestyle sessions will include the following topics:
Movement -passive stretches and dynamic stretches, cardio HIIT exercise, flexibility and
strength, and core and balance.
Nutrition Body - Include healthy eating with whole, clean, and nutritionally balanced
meals; menu planning/prepping, snacking and noticing cravings and feelings of fullness or
satiety.
Sleep - Include routine for evening, and morning for optimal sleep, logging routines and
quality of sleep, tools to aid in falling asleep, and returning to sleep during the
night, eating and sleep patterns Nature/Culture/Arts (with Kemper Museum of Contemporary
Art - which will also take place during ½ day retreat) includes spending time in nature
and journal experiences, reconnecting with the sun, and surround self with nature.
Financial - Focus on financial wellbeing, budgets/adjustments to budgets, and
buying/spending patterns.
Cooking - Include healthy foods, smoothies, juices, kitchen appliances.
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
Washington University
St Louis 4407066, Missouri 4398678, United States
Jay Piccirillo, MD, Principal Investigator
Washington University School of Medicine