Mindfulness-Based Stress Reduction Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia (NCT06789952) | Clinical Trial Compass
TerminatedNot Applicable
Mindfulness-Based Stress Reduction Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia
Stopped: Difficulties in recruitment
United States41 participantsStarted 2023-09-06
Plain-language 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)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Global Impression of Improvement Scale (CGI-I)
Timeframe: Measured after completing 8 weeks of assigned intervention