COVID-19 Long Haul SyndromeNCT04854772
Mind Body Intervention for COVID-19 Long Haul Syndrome
A study testing Mind Body Syndrome Therapy for Long Covid in people with COVID-19 Long Haul Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19 Long Haul Syndrome
- What is being tested?
- Mind Body Syndrome Therapy for Long Covid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 9 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Conditions
- COVID-19 Long Haul Syndrome
- Being tested
- Mind Body Syndrome Therapy for Long Covid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind Body Syndrome Therapy for Long CovidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mind Body Syndrome Therapy for Long Covid | Experimental | 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 Receives: Behavioral: Mind Body Syndrome Therapy for Long Covid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 4, 8, and 13 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 4, 8, and 13 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start15 May 2021
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Long Haul SyndromeStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility/pilot Study
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Donnino, Beth Israel Deaconess Medical Center
- Investigators
- Michael Donnino, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854772
- Sponsor's protocol ID
- 2021P-000336
- Status last verified
- Aug 2022
- First submitted
- 20 Apr 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Donnino M, Howard P, Mehta S, Silverman J, Cabrera MJ, Yamin JB, Balaji L, Berg KM, Heydrick S, Edwards R, Grossestreuer AV. Psychophysiologic Symptom Relief Therapy (PSRT) for Post-acute Sequelae of COVID-19. Mayo Clin Proc Innov Qual Outcomes. 2023 May 19;7(4):337-48. doi: 10.1016/j.mayocpiqo.2023.05.002. Online ahead of print.
PubMed 37361483
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Body Intervention for COVID-19 Long Haul Syndrome
- ClinicalTrials.gov ID
- NCT04854772
- Acronym / sponsor ID
- 2021P-000336
- Conditions
- COVID-19 Long Haul Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility/pilot Study
| Arm | Type | Receives |
|---|---|---|
| Mind Body Syndrome Therapy for Long Covid | Experimental | Behavioral: Mind Body Syndrome Therapy for Long CovidThe 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind Body Syndrome Therapy for Long CovidThe 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. | Behavioural | Mind Body Syndrome Therapy for Long Covid |
Primary outcome
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)
7 secondary outcomes
Average Pain
Time frame: Baseline, 4, 8, and 13 weeks
Pain intensity
Time frame: Baseline 4, 8, and 13 weeks
Pain-related Anxiety
Time frame: Baseline 4, 8, 13 weeks
Fatigue
Time frame: Baseline 4, 8, 13 weeks
Dyspnea
Time frame: Baseline 4, 8, and 13 weeks
Brain Fog
Time frame: Baseline, 4, 8, and 13 weeks
Physical Functioning
Time frame: Baseline, 4, 8, and 13 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Derived from this study: PubMed 37361483Donnino M, Howard P, Mehta S, Silverman J, Cabrera MJ, Yamin JB, Balaji L, Berg KM, Heydrick S, Edwards R, Grossestreuer AV. Psychophysiologic Symptom Relief Therapy (PSRT) for Post-acute Sequelae of COVID-19. Mayo Clin Proc Innov Qual Outcomes. 2023 May 19;7(4):337-48. doi: 10.1016/j.mayocpiqo.2023.05.002. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for COVID-19 Long Haul Syndrome
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Post-Concussion Syndrome, COVID Long-Haul
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Long-Covid-19 Alleviation Through Learning Mindfulness Study
Long COVID, Long Covid19
Recruiting
Covid-19 Long Immunité IMagerie (CLIIM)
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Mind Body Intervention for Long COVID-19
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Donnino, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind Body Syndrome Therapy for Long Covid in people with COVID-19 Long Haul Syndrome, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in somatic symptom severity (time frame: Baseline, 4, 8, and 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.