Mind Body Intervention for Long COVID

Long COVID Clinical Trial

Official title:

Mind Body Intervention for Long COVID

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06045338
• Other study ID #: 2023P000529
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: January 2026

Study information

• Verified date: September 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Samuel Kukler
• Phone: 617-754-2882
• Email: skukler[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with Long COVID. The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates individual somatic complaints and improves daily functioning, relative to usual care and the active control

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Adult (= 18 years of age)

2. Infection with Sars-COV2 (i. e., positive antibody, antigen, or PCR testing)

3. Symptoms attributed only to COVID-19 and not to known comorbid disease (e.g., other infections, cancer, etc)

4. A somatic symptom score = 10 on the SSS-8 questionnaire with involvement of at least 3 domains

5. Symptoms present at least 3 day a week for a minimum of 3 months

6. Willingness to engage in a Mind-Body intervention

Exclusion Criteria:

1. Clear diagnosis of physical disease (e.g. lung fibrosis, myocarditis) not inclusive of non-specific findings such as mild arthritis

2. Hospitalization in an intensive care unit for acute COVID-19 infections

3. Age greater than 65 years

4. Diagnosis of dementia or similar cognitive impairment

5. Active addiction disorder (e.g. cocaine) that would interfere with study participation

6. Major psychiatric comorbidity (e.g., schizophrenia). Mild to moderate anxiety and depression are not considered in this category

Related Conditions & MeSH terms

• Long COVID

Intervention

Behavioral:
• Mind Body Intervention #1
The mind-body intervention will include regular 1 to 2 hour educational sessions and lectures, as well as supplemental reading material. In addition, individualized sessions will be offered each week for students who have additional questions and/or need additional time with the material.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Somatic Symptom Score-8 (SSS-8)	Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints	Baseline, 4 weeks, 8 weeks, 13 weeks
Secondary	Short Form Brief Pain Inventory (BPI)	Used to gauge pain intensity, and pain interference with daily function over the duration of the study	Baseline, 4 weeks, 8 weeks, 13 weeks
Secondary	Fatigue Severity Scale (FSS)	Consists of statements relating to a patient's general level of fatigue and fatigue with specific activities	Baseline, 4 weeks, 8 weeks, 13 weeks
Secondary	The Multidimensional Dyspnea Profile (MDP)	A survey that assesses perceived physical aspects of dyspnea and associated emotional effects	Baseline, 4 weeks, 8 weeks, 13 weeks
Secondary	Generalized Anxiety Disorder form 7 (GAD-7)	Self-report instrument assessing general anxiety over the last two weeks	Baseline and 13 weeks
Secondary	Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)	a standardized assessment of health-related quality of life	Baseline, 4 weeks, 8 weeks, 13 weeks
Secondary	End of study measurements	Participants' subjective experience of the program upon completion	13 weeks
Secondary	Pain Anxiety Symptom Score-20 (Pass-20)	Anxiety from pain determined from 20 item survey	Baseline, 4 weeks, 8 weeks, 13 weeks