Mindfulness-Based Stress Reduction Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia (MBSR-LCP)

January 22, 2025 updated by: Jay F. Piccirillo, MD, Washington University School of Medicine

Mindfulness-Based Stress Reduction (MBSR) Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia (LCP)

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression of Improvement Scale (CGI-I)
Time Frame: Measured after completing 8 weeks of assigned intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression-Severity Scale for Parosmics (CGI-P)
Time Frame: Measure will be taken at baseline and after 8-week intervention
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.
Measure will be taken at baseline and after 8-week intervention
DysODOR
Time Frame: Measure will be taken at baseline and after 8-week intervention
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)
Time Frame: Measure will be taken at baseline and after 8-week intervention
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)
Time Frame: Measure will be taken at baseline and after 8-week intervention
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
Time Frame: Measure will be taken at baseline
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
Time Frame: Measure will be taken at baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Jay Piccirillo, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202206182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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