Mind Body Intervention for COVID-19 Long Haul Syndrome

Not Applicable

Completed

• Conditions: COVID-19 Long Haul Syndrome
• Interventions: Behavioral: Mind Body Syndrome Therapy for Long Covid

• Registration Number: NCT04854772
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Study Start: 2021-05-15
• Status Verified: 2022-08
• Primary Completion: 2022-08-09
• Study Completion: 2022-08-09
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mind Body Syndrome Therapy for Long Covid	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

Primary Outcome Measures

Name	Time	Method
Change in somatic symptom severity	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 Outcome Measures

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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States