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

Not Applicable

Terminated

• Conditions: COVID-19

• Registration Number: NCT06789952
• Lead Sponsor: Washington University School of Medicine

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)

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 Timeline

• Study First Submitted: 2023-01-26
• Study Start: 2023-09-06
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression of Improvement Scale (CGI-I)	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Severity Scale for Parosmics (CGI-P)	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.
DysODOR	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.
The Smell Catastrophizing Scale - 13 Items (SCS)	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.
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)	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.
The Acceptability Questionnaire - 10 Items	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,
The Credibility and Expectancy Questionnaire - Parosmia (CEQ-P) - 6 Items	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.

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States