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Mind Body Intervention for COVID-19 Long Haul Syndrome

Primary Purpose

COVID-19 Long Haul Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mind Body Syndrome Therapy for Long Covid

About this trial

This is an interventional treatment trial for COVID-19 Long Haul Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mind Body Syndrome Therapy for Long Covid

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

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.

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

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

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.

Brain Fog

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

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.

Full Information

NCT ID

NCT04854772

First Posted

April 20, 2021

Last Updated

August 18, 2022

Sponsor

Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04854772

Brief Title

Mind Body Intervention for COVID-19 Long Haul Syndrome

Official Title

Mind Body Intervention for COVID-19 Long Haul Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

May 15, 2021 (Actual)

Primary Completion Date

August 9, 2022 (Actual)

Study Completion Date

August 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Long Haul Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Feasibility/pilot Study

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mind Body Syndrome Therapy for Long Covid

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mind Body Syndrome Therapy for Long Covid

Intervention Description

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 Outcome Measure Information:

Title

Change in somatic symptom severity

Description

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)

Time Frame

Baseline, 4, 8, and 13 weeks

Secondary Outcome Measure Information:

Title

Average Pain

Description

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.

Time Frame

Baseline, 4, 8, and 13 weeks

Title

Pain intensity

Description

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.

Time Frame

Baseline 4, 8, and 13 weeks

Title

Pain-related Anxiety

Description

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

Time Frame

Baseline 4, 8, 13 weeks

Title

Fatigue

Description

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

Time Frame

Baseline 4, 8, 13 weeks

Title

Dyspnea

Description

Time Frame

Baseline 4, 8, and 13 weeks

Title

Brain Fog

Description

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

Time Frame

Baseline, 4, 8, and 13 weeks

Title

Physical Functioning

Description

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.

Time Frame

Baseline, 4, 8, and 13 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Donnino, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mind Body Intervention for COVID-19 Long Haul Syndrome

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