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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Long Haul Syndrome
• Intervention / Treatment: Behavioral: Mind Body Syndrome Therapy for Long Covid

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mind Body Syndrome Therapy for Long Covid; The participants will receive an initial one-on-one interview, followed by 1 to 2 hour biweekly group interactive, educational sessions for 12 weeks. This program also includes a day-long "retreat" at the end of the required course period. Participants will also be provided reading materials to study during the intervention period	Behavioral: Mind Body Syndrome Therapy for Long Covid; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in somatic symptom severity	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)	Baseline, 4, 8, and 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain	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.	Baseline, 4, 8, and 13 weeks
Pain intensity	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.	Baseline 4, 8, and 13 weeks
Pain-related Anxiety	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	Baseline 4, 8, 13 weeks
Fatigue	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	Baseline 4, 8, 13 weeks
Dyspnea	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.	Baseline 4, 8, and 13 weeks
Brain Fog	Will be assessed using a numerical rating scale (0-5). Higher numbers represent more severe of brain fog	Baseline, 4, 8, and 13 weeks
Physical Functioning	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.	Baseline, 4, 8, and 13 weeks.

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Michael Donnino, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): August 9, 2022
• Study Completion (Actual): August 9, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome
• Other Study ID Numbers: 2021P-000336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No