An interventional study of Mindfulness-Based Stress Reduction and Lifestyle Intervention in COVID-19, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 41 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Exclusion Criteria:
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
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
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
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.
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.
Time frame: Measured after completing 8 weeks of assigned intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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,
Time frame: 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.
Time frame: Measure will be taken at baseline
Plan to share: No
Ran from Sep 2023 to primary completion in Nov 2023, 2 months.
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This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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