Mindfulness-Based Stress Reduction Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia
NCT ID: NCT06789952
Last Updated: 2025-01-23
Study Results
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Basic Information
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TERMINATED
NA
41 participants
INTERVENTIONAL
2023-09-06
2023-11-30
Brief Summary
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Therefore, we propose a Pilot single-site clinical trial to explore the efficacy of MBSR for Covid-19-related smell distortion (parosmia)
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Mindfulness-Based Stress Reduction
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.
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
Lifestyle Intervention
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.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Jay F. Piccirillo, MD
Vice Chair for Research, Department of Otolaryngology
Principal Investigators
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Jay Piccirillo, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University
St Louis, Missouri, United States
Countries
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References
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Other Identifiers
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202206182
Identifier Type: -
Identifier Source: org_study_id
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