Mind Body Intervention for Long COVID-19

Not Applicable

Recruiting

• Conditions: Long COVID; Post-Acute Sequelae of COVID-19; COVID Long-Haul
• Interventions: Behavioral: Mind Body Intervention #1

• Registration Number: NCT06045338
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-21
• Study Start: 2023-11-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-10
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind Body Intervention #1	Mind Body Intervention #1	-
Mind Body Intervention #2	Mind Body Intervention #1	-

Primary Outcome Measures

Name	Time	Method
Somatic Symptom Score-8 (SSS-8)	Baseline, 4 weeks, 8 weeks, 13 weeks	Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints. Range of 0-32, with higher scores indicating higher levels of discomfort.

Secondary Outcome Measures

Name	Time	Method
Short Form Brief Pain Inventory (BPI)	Baseline, 4 weeks, 8 weeks, 13 weeks	Used to gauge pain intensity, and pain interference with daily function over the duration of the study
Generalized Anxiety Disorder form 7 (GAD-7)	Baseline and 13 weeks	Self-report instrument assessing general anxiety over the last two weeks. Each of the 7 item is a statement concerning an anxiety trait, respondents then rate how often that statement is true. Responses range from 0 (not at all) to 3 (nearly every day).
Fatigue Severity Scale (FSS)	Baseline, 4 weeks, 8 weeks, 13 weeks	Consists of statements relating to a patient's general level of fatigue and fatigue with specific activities. Range of 7-63, with higher scores indicating a higher degree of fatigue.
Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)	Baseline, 4 weeks, 8 weeks, 13 weeks	a standardized assessment of health-related quality of life
The Multidimensional Dyspnea Profile (MDP)	Baseline, 4 weeks, 8 weeks, 13 weeks	A survey that assesses perceived physical aspects of dyspnea and associated emotional effects. Each of the rating scales within the MDP is designed to measure a separate construct, though each can be grouped between the two above mentioned domains.
End of study measurements	13 weeks	Participants' subjective experience of the program upon completion
Pain Anxiety Symptom Score-20 (Pass-20)	Baseline, 4 weeks, 8 weeks, 13 weeks	Anxiety from pain determined from 20 item survey, with each item being scored from 1-5 in terms of frequency

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States