Mindfulness-Based Stress Reduction (MBSR) Versus Lifestyle Intervention for Long-Haul Covid-19 Parosmia (LCP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Clinical Global Impression of Improvement Scale (CGI-I)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Clinical Global Impression of Improvement Scale (CGI-I)
时间窗: 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.
次要结局
- 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)
- The Credibility and Expectancy Questionnaire - Parosmia (CEQ-P) - 6 Items(Measure will be taken at baseline)
研究者
Jay F. Piccirillo, MD
Vice Chair for Research, Department of Otolaryngology
Washington University School of Medicine