Clinical trial NCT06045338: Mind Body Intervention for Long COVID-19
Official title: Mind Body Intervention for Long COVID
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long COVID
Post-Acute Sequelae of COVID-19
COVID Long-Haul
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Somatic Symptom Score-8 (SSS-8)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
Secondary outcomes:
measure: Short Form Brief Pain Inventory (BPI)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
measure: The Multidimensional Dyspnea Profile (MDP)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
measure: Generalized Anxiety Disorder form 7 (GAD-7)
timeFrame: Baseline and 13 weeks
measure: Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
measure: End of study measurements
timeFrame: 13 weeks
measure: Pain Anxiety Symptom Score-20 (Pass-20)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michael Donnino, MD
role: PRINCIPAL_INVESTIGATOR
References: