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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | 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. |
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| Lifestyle Intervention | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction | Behavioral | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Improvement Scale (CGI-I) | The CGI-Improvement is a self-reported scale of improvement ranging from 1=Very Much Improved to, 7=Very Much Worsened in answer to the question "Compared to the start of the study, how would you rate how intrusive smell distortion (change) is in your life after 8 weeks of intervention". Participants reporting 3 as Minimally Improved, 2 as Much Improved, or 1 as Very Much Improved in the CGI-I will be defined responders to treatment. The response rate is defined as the number of participants self-reporting a score of 3 or less, devided by the total number of participants in the intervention group. | Measured after completing 8 weeks of assigned intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression-Severity Scale for Parosmics (CGI-P) | The CGI-P Scale is a global rating of the severity of parosmia assessed by the response to the question: "Overall, how would you rate your current distortion (change) of smell?" The single global rating ranges from 1-5, where 1 is No Distortion, 2 is Mild Distortion, 3 is Moderate Distortion, 4 is Mostly Distorted, and 5 is Complete Distortion. |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Piccirillo, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32253535 | Background | Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6. | |
| 34792577 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000857 | Olfaction Disorders |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Lifestyle Intervention | Behavioral | 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. |
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| Measure will be taken at baseline and after 8-week intervention |
| DysODOR | The DysODOR questionnaire is a disease-specific health status survey to assess the physical problems, functional impairments, and emotional consequences secondary to olfactory dysfunction. | Measure will be taken at baseline and after 8-week intervention |
| The Smell Catastrophizing Scale - 13 Items (SCS) | The CSC asks the participants to describe the degree to which they have specific thoughts and feelings as a result of their sense of smell problems. | Measure will be taken at baseline and after 8-week intervention |
| The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) | The DASS-21 is a set of three self-report scales designed to measure the emotional state of depression, anxiety, and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non- specific arousal and assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. | Measure will be taken at baseline and after 8-week intervention |
| The Acceptability Questionnaire - 10 Items | The Acceptability Questionnaire contains a total 10 items. The first seven assess participants' views of the treatment through a scale 1 - 9 (1 not at all to 9 very positive about treatment). The last three are short answer questions to assess confidence in treatment, | Measure will be taken at baseline |
| The Credibility and Expectancy Questionnaire - Parosmia (CEQ-P) - 6 Items | The CEQ-P is divided into two sets of questions. Set 1 contains four questions that focus on what the participant thinks while Set 2 contains two questions that focus on what the participant feels. CEQ-P explores a participant's belief towards treatment. | Measure will be taken at baseline |
| Background |
| Khan AM, Kallogjeri D, Piccirillo JF. Growing Public Health Concern of COVID-19 Chronic Olfactory Dysfunction. JAMA Otolaryngol Head Neck Surg. 2022 Jan 1;148(1):81-82. doi: 10.1001/jamaoto.2021.3379. |
| 24395196 | Background | Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018. |
| 32563019 | Background | Meng X, Deng Y, Dai Z, Meng Z. COVID-19 and anosmia: A review based on up-to-date knowledge. Am J Otolaryngol. 2020 Sep-Oct;41(5):102581. doi: 10.1016/j.amjoto.2020.102581. Epub 2020 Jun 2. |
| 32167747 | Background | Baig AM, Khaleeq A, Ali U, Syeda H. Evidence of the COVID-19 Virus Targeting the CNS: Tissue Distribution, Host-Virus Interaction, and Proposed Neurotropic Mechanisms. ACS Chem Neurosci. 2020 Apr 1;11(7):995-998. doi: 10.1021/acschemneuro.0c00122. Epub 2020 Mar 13. |
| 20231262 | Background | Bitter T, Gudziol H, Burmeister HP, Mentzel HJ, Guntinas-Lichius O, Gaser C. Anosmia leads to a loss of gray matter in cortical brain areas. Chem Senses. 2010 Jun;35(5):407-15. doi: 10.1093/chemse/bjq028. Epub 2010 Mar 15. |
| 26624966 | Background | Pekala K, Chandra RK, Turner JH. Efficacy of olfactory training in patients with olfactory loss: a systematic review and meta-analysis. Int Forum Allergy Rhinol. 2016 Mar;6(3):299-307. doi: 10.1002/alr.21669. Epub 2015 Dec 1. |
| 33790036 | Background | Saniasiaya J, Narayanan P. Parosmia post COVID-19: an unpleasant manifestation of long COVID syndrome. Postgrad Med J. 2021 Mar 31:postgradmedj-2021-139855. doi: 10.1136/postgradmedj-2021-139855. Online ahead of print. No abstract available. |
| 17006637 | Background | Reden J, Maroldt H, Fritz A, Zahnert T, Hummel T. A study on the prognostic significance of qualitative olfactory dysfunction. Eur Arch Otorhinolaryngol. 2007 Feb;264(2):139-44. doi: 10.1007/s00405-006-0157-0. Epub 2006 Sep 28. |
| 481748 | Background | Graziadei PP, Levine RR, Monti Graziadei GA. Plasticity of connections of the olfactory sensory neuron: regeneration into the forebrain following bulbectomy in the neonatal mouse. Neuroscience. 1979;4(6):713-27. doi: 10.1016/0306-4522(79)90002-2. No abstract available. |
| 11192906 | Background | Seiden AM, Duncan HJ. The diagnosis of a conductive olfactory loss. Laryngoscope. 2001 Jan;111(1):9-14. doi: 10.1097/00005537-200101000-00002. |
| 28556265 | Background | Cavazzana A, Larsson M, Munch M, Hahner A, Hummel T. Postinfectious olfactory loss: A retrospective study on 791 patients. Laryngoscope. 2018 Jan;128(1):10-15. doi: 10.1002/lary.26606. Epub 2017 May 29. |
| 29901865 | Background | Nguyen TP, Patel ZM. Budesonide irrigation with olfactory training improves outcomes compared with olfactory training alone in patients with olfactory loss. Int Forum Allergy Rhinol. 2018 Sep;8(9):977-981. doi: 10.1002/alr.22140. Epub 2018 Jun 14. |
| 1609875 | Background | Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936. |
| Background | Kabat-Zinn J. Mindfulness Meditation: What It Is, What It Isn't, And It's Role in Health Care and Medicine. In: Haruki YI, Y.; Suzuki, M., ed. Comparative and Psychological Study on Meditation. Netherlands: Eburon; 1996:161 - 169. |
| 20141305 | Background | Goldin PR, Gross JJ. Effects of mindfulness-based stress reduction (MBSR) on emotion regulation in social anxiety disorder. Emotion. 2010 Feb;10(1):83-91. doi: 10.1037/a0018441. |
| 19733812 | Background | Deyo M, Wilson KA, Ong J, Koopman C. Mindfulness and rumination: does mindfulness training lead to reductions in the ruminative thinking associated with depression? Explore (NY). 2009 Sep-Oct;5(5):265-71. doi: 10.1016/j.explore.2009.06.005. |
| 21041554 | Background | Lengacher CA, Johnson-Mallard V, Barta M, Fitzgerald S, Moscoso MS, Post-White J, Jacobsen PB, Molinari Shelton M, Le N, Budhrani P, Goodman M, Kip KE. Feasibility of a mindfulness-based stress reduction program for early-stage breast cancer survivors. J Holist Nurs. 2011 Jun;29(2):107-17. doi: 10.1177/0898010110385938. Epub 2010 Nov 1. |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 |
| Behavioral Disciplines and Activities |