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Recruiting NCT06045338

Mind Body Intervention for Long COVID-19

No phase Interventional Long COVID Post-Acute Sequelae of COVID-19 COVID Long-Haul

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mind Body Intervention #1.
Who it may be relevant to
Registry conditions: Long COVID, Post-Acute Sequelae of COVID-19, COVID Long-Haul. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Mind Body Intervention for Long COVID

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Somatic Symptom Score-8 (SSS-8) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
Secondary outcome measures (8)
  • Short Form Brief Pain Inventory (BPI) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
  • Fatigue Severity Scale (FSS) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
  • The Multidimensional Dyspnea Profile (MDP) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
  • Generalized Anxiety Disorder form 7 (GAD-7) [Time frame: Baseline and 13 weeks]
  • Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
  • End of study measurements [Time frame: 13 weeks]
  • Pain Anxiety Symptom Score-20 (Pass-20) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
  • Patient Reported Outcomes Measurement Information System Survey for Cognitive Function (PROMIS SF v2.0 cognitive function 8a) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT06045338 · 2023P000529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗