Clinical trial NCT06789952: Mindfulness-Based Stress Reduction Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia
Official title: Mindfulness-Based Stress Reduction (MBSR) Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia (LCP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19
Keywords: Parosmia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Global Impression of Improvement Scale (CGI-I)
timeFrame: Measured after completing 8 weeks of assigned intervention
Secondary outcomes:
measure: Clinical Global Impression-Severity Scale for Parosmics (CGI-P)
timeFrame: Measure will be taken at baseline and after 8-week intervention
measure: DysODOR
timeFrame: Measure will be taken at baseline and after 8-week intervention
measure: The Smell Catastrophizing Scale - 13 Items (SCS)
timeFrame: Measure will be taken at baseline and after 8-week intervention
measure: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
timeFrame: Measure will be taken at baseline and after 8-week intervention
measure: The Acceptability Questionnaire - 10 Items
timeFrame: Measure will be taken at baseline
measure: The Credibility and Expectancy Questionnaire - Parosmia (CEQ-P) - 6 Items
timeFrame: Measure will be taken at baseline
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jay Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
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