Mindfulness-Based Stress Reduction Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia

NCT06789952 | Terminated DMC

• 1 other identifier: 202206182
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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)

Conditions

COVID-19

Keywords

Parosmia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Clinical Global Impression-Severity Scale for Parosmics (CGI-P)

  Measure will be taken at baseline and after 8-week intervention

• DysODOR

  Measure will be taken at baseline and after 8-week intervention

• The Smell Catastrophizing Scale - 13 Items (SCS)

  Measure will be taken at baseline and after 8-week intervention

• The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

  Measure will be taken at baseline and after 8-week intervention

• The Acceptability Questionnaire - 10 Items

  Measure will be taken at baseline

Study Arms (2)

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.

Behavioral: Mindfulness-Based Stress Reduction

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.

Behavioral: Lifestyle Intervention

Interventions

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: * 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

Mindfulness-Based Stress Reduction

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.

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (26)

• 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.

  PMID: 32253535 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.

  PMID: 34792577 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.

  PMID: 24395196 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.

  PMID: 32563019 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.

  PMID: 32167747 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.

  PMID: 20231262 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.

  PMID: 26624966 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.

  PMID: 33790036 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.

  PMID: 17006637 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.

  PMID: 481748 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.

  PMID: 11192906 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.

  PMID: 28556265 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.

  PMID: 29901865 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.

  PMID: 1609875 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.

  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.

  PMID: 20141305 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.

  PMID: 19733812 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.

  PMID: 21041554 BACKGROUND

• Gross CR, Kreitzer MJ, Reilly-Spong M, Wall M, Winbush NY, Patterson R, Mahowald M, Cramer-Bornemann M. Mindfulness-based stress reduction versus pharmacotherapy for chronic primary insomnia: a randomized controlled clinical trial. Explore (NY). 2011 Mar-Apr;7(2):76-87. doi: 10.1016/j.explore.2010.12.003.

  PMID: 21397868 BACKGROUND

• Fjorback LO, Arendt M, Ornbol E, Fink P, Walach H. Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Acta Psychiatr Scand. 2011 Aug;124(2):102-19. doi: 10.1111/j.1600-0447.2011.01704.x. Epub 2011 Apr 28.

  PMID: 21534932 BACKGROUND

• Sullivan M. PCS The Pain Catastrophizing Scale. In. Montreal, Quebec2009.

  BACKGROUND

• Sullivan MJLB, S.R.; Pivik, J. The Pain Catastrophizing Scale: Development and Validation. Pschol Asses. 1995;7(4):524-532.

  BACKGROUND

• Lovibond SHL, P.F. Manual for the Depression Anxiety & Stress Scales. 2nd ed. Sydney, Australia: Psychology Foundation.; 1995.

  BACKGROUND

• Santorelli SF. Mindfulness-Based Stress Reduction (MBSR): Standards of Practice. Worcester, MA: University of Massachusetts Medical School; 2014:24.

  BACKGROUND

• Stahl B, Goldstein E. Mindfulness-Based Stress Reduction Workbook. Oakland, CA: New Harbinger Publications, Inc; 2010.

  BACKGROUND

• Chatterjee, Rangan. Stress Solution: The 4 Steps to Reset Your Body, Mind, Relationships and Purpose. Penguin Books, Limited, 2019.

  BACKGROUND

MeSH Terms

Conditions

COVID-19; Olfaction Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jay Piccirillo, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Research, Department of Otolaryngology

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: January 23, 2025
• Study Start: September 6, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)