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NCT Number: NCT06045338

Mind Body Intervention for Long COVID-19

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

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Key information

Conditions

Long COVID COVID Long-Haul COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders Post-acute Sequelae of COVID-19 RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Ashley Scafetta

CONTACT

[email protected]

617-754-2882

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Somatic Symptom Score-8 (SSS-8)

    Time frame: 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 outcomes

  1. Short Form Brief Pain Inventory (BPI)

    Time frame: 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)

    Time frame: 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.

  3. The Multidimensional Dyspnea Profile (MDP)

    Time frame: 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.

  4. Generalized Anxiety Disorder form 7 (GAD-7)

    Time frame: 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).

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

    Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks

    a standardized assessment of health-related quality of life

  6. End of study measurements

    Time frame: 13 weeks

    Participants' subjective experience of the program upon completion

  7. Pain Anxiety Symptom Score-20 (Pass-20)

    Time frame: 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

  8. 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

    Cognition assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Scafetta

CONTACT

[email protected]

617-754-2882

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Mind Body Intervention for Long COVID

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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