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Completed

NCT Number: NCT04854772

Mind Body Intervention for COVID-19 Long Haul Syndrome

The present study is a feasibility study in which we will determine if a mind-body program that we have previously developed for chronic back pain can improve the multiple somatic complaints associated with the COVID Long Haul Syndrome.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

This study is a pilot and feasibility study to determine if a mind-body program that we have previously developed for chronic back pain can improve the multiple somatic complaints associated with the COVID Long Haul Syndrome in patients without evidence of ongoing tissue injury. We will perform a 12-week intervention consisting of a series of classes which will focus on knowledge therapy, desensitization, emotional expression, and stress reduction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient ≥ 18 years old
  • New symptoms attributed to the post-covid long-haul syndrome (extremity pain, dyspnea, headaches, chest pain, fatigue) occurring after an acute phase of COVID19
  • Minimum of at least 12 weeks after the end of the acute phase of COVID-19 infection
  • Persistence of symptoms for a least 1 month with no identified other organic etiology
  • Score ≥ 3 or more on the SSS-8 score
  • Symptoms present for a minimum of 4 days a week
  • Willingness to consider mind-body intervention

Exclusion criteria

  • Patients < 18 years of age
  • Patients > 60 years of age
  • Diagnosed (non-COVID-19) organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome (note that pain related to disc disease is not an exclusion unless there are neurological impairments).
  • Patients with previous severe COVID-19 disease, defined as those who had been admitted to the ICU or have objective evidence of ongoing organ injury (e.g., persistent chest radiographic abnormalities or myocarditis)
  • Identified lung or cardiac injury in subjects with chest pain or dyspnea (e.g., chest radiograph abnormalities, cardiac ultrasound showing myocarditis or depressed ejection fraction )
  • Patients with a diagnosis of significant psychiatric comorbidities such as schizophrenia or dementia

Treatment and study plan

Mind Body Syndrome Therapy for Long Covid

Behavioral

The intervention consists of a mind-body based intervention for the COVID long haul syndrome. The components of the intervention include knowledge therapy, desensitization, emotional expression, and stress reduction techniques.

Primary outcomes

  1. Change in somatic symptom severity

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

    Will be assessed using the Somatic Symptom Scale-8 (SSS-8). The minimum score is 0 and the maximum 32, with higher values indicating a worse outcome (more severe symptoms)

Secondary outcomes

  1. Average Pain

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

    Will be assessed using the Brief Pain Inventory (BPI). The minimum score is 0 and the maximum is 10, with higher values indicating higher pain.

  2. Pain intensity

    Time frame: Baseline 4, 8, and 13 weeks

    Will be assessed using the Brief Pain Inventory (BPI). The minimum score is 0 and the maximum is 10, with higher values indicating higher pain.

  3. Pain-related Anxiety

    Time frame: Baseline 4, 8, 13 weeks

    Will be assessed using the Pain Anxiety Symptom Scale (PASS). The minimum score is 0 and the maximum 100, with higher values indicating higher pain anxiety

  4. Fatigue

    Time frame: Baseline 4, 8, 13 weeks

    Will be assessed using the Fatigue Severity Scale (FSS). The minimum score is 9 and the maximum 63, with higher scores indicating greater fatigue severity

  5. Dyspnea

    Time frame: Baseline 4, 8, and 13 weeks

    Will be assessed using the Multidimensional Dyspnea Profile (MDP). A1, Scale: Scale about breathing sensations with a defined start- and endpoint (neutral - unbearable). Values reach from 0-10, and higher values represent a worse outcome.

    SQ1 (sensoric quality), Choice: 5 Phrases and terms about breathing sensations. Choose between yes and no and select one as "most accurately".

    SQ2 (sensoric quality), Scales: 5 subscales about intensity of breathing sensations. Values reach from 0 - 10, and higher values represent a worse outcome.

    A2 (emotional quality), Scales: 5 subscales about emotions. Values reach from 0 - 10, and higher values represent a worse outcome.

  6. Brain Fog

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

    Will be assessed using a numerical rating scale (0-5). Higher numbers represent more severe of brain fog

  7. Physical Functioning

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

    Will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) The minimum score is 0 and maximum is 16. Higher numbers represent less physical functioning capacity.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2021
Registry last updated
Aug 19, 2022

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.