Mind Body Intervention for Long COVID

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06045338
• Collaborator: (none)
• Enrollment: 180
• Arms: 3
• Anticipated Duration (Months): 27

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Long COVID; Post-Acute Sequelae of COVID-19; COVID Long-Haul	Behavioral: Mind Body Intervention #1	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mind Body Intervention for Long COVID
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2025
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mind Body Intervention #1	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.
Active Comparator: Mind Body Intervention #2	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.
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

1. 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

Secondary Outcome Measures

1. 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

2. 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

3. 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

4. Generalized Anxiety Disorder form 7 (GAD-7) [Baseline and 13 weeks]

   Self-report instrument assessing general anxiety over the last two weeks

5. 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

6. End of study measurements [13 weeks]

   Participants' subjective experience of the program upon completion

7. Pain Anxiety Symptom Score-20 (Pass-20) [Baseline, 4 weeks, 8 weeks, 13 weeks]

   Anxiety from pain determined from 20 item survey

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Michael Donnino, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Donnino, Physician, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT06045338
• Other Study ID Numbers: 2023P000529
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Post-Acute COVID-19 Syndrome

Study Results

No Results Posted as of Sep 21, 2023