Mind Body Intervention for Long COVID-19

NCT06045338 | Recruiting

• 1 other identifier: 2023P000529
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Long COVID; Post-Acute Sequelae of COVID-19; COVID Long-Haul

Outcome Measures

Primary Outcomes (1)

• Somatic Symptom Score-8 (SSS-8)

  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.

  Baseline, 4 weeks, 8 weeks, 13 weeks

Secondary Outcomes (8)

• Short Form Brief Pain Inventory (BPI)

  Baseline, 4 weeks, 8 weeks, 13 weeks

• Fatigue Severity Scale (FSS)

  Baseline, 4 weeks, 8 weeks, 13 weeks

• The Multidimensional Dyspnea Profile (MDP)

  Baseline, 4 weeks, 8 weeks, 13 weeks

• Generalized Anxiety Disorder form 7 (GAD-7)

  Baseline and 13 weeks

• Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)

  Baseline, 4 weeks, 8 weeks, 13 weeks

Study Arms (3)

Mind Body Intervention #1

EXPERIMENTAL

Behavioral: Mind Body Intervention #1

Mind Body Intervention #2

ACTIVE COMPARATOR

Behavioral: Mind Body Intervention #1

Usual Care

NO INTERVENTION

Interventions

Mind Body Intervention #1 BEHAVIORAL

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.

Mind Body Intervention #1; Mind Body Intervention #2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥ 18 years of age)
• Infection with Sars-COV2 (i. e., positive antibody, antigen, or PCR testing)
• Symptoms attributed only to COVID-19 and not to known comorbid disease (e.g., other infections, cancer, etc)
• A somatic symptom score ≥ 10 on the SSS-8 questionnaire with involvement of at least 3 domains
• Symptoms present at least 3 day a week for a minimum of 3 months
• Willingness to engage in a Mind-Body intervention

You may not qualify if:

• Clear diagnosis of physical disease (e.g. lung fibrosis, myocarditis) not inclusive of non-specific findings such as mild arthritis
• Hospitalization in an intensive care unit for acute COVID-19 infections
• Age greater than 65 years
• Diagnosis of dementia or similar cognitive impairment
• Active addiction disorder (e.g. cocaine) that would interfere with study participation
• Major psychiatric comorbidity (e.g., schizophrenia). Mild to moderate anxiety and depression are not considered in this category

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Donnino, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Scafetta

CONTACT

617-754-2882; ascafett@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 21, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)