Clinical trial NCT04854772: Mind Body Intervention for COVID-19 Long Haul Syndrome
Official title: Mind Body Intervention for COVID-19 Long Haul Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Long Haul Syndrome
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility/pilot Study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in somatic symptom severity
timeFrame: Baseline, 4, 8, and 13 weeks
Secondary outcomes:
measure: Average Pain
timeFrame: Baseline, 4, 8, and 13 weeks
measure: Pain intensity
timeFrame: Baseline 4, 8, and 13 weeks
measure: Pain-related Anxiety
timeFrame: Baseline 4, 8, 13 weeks
measure: Fatigue
timeFrame: Baseline 4, 8, 13 weeks
measure: Dyspnea
timeFrame: Baseline 4, 8, and 13 weeks
measure: Brain Fog
timeFrame: Baseline, 4, 8, and 13 weeks
measure: Physical Functioning
timeFrame: Baseline, 4, 8, and 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: