Long COVIDNCT06045338
Mind Body Intervention for Long COVID-19
A study testing Mind Body Intervention #1 in people with Long COVID and Post-Acute Sequelae of COVID-19, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with Long COVID. The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants as compared to usual care and an… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID, Post-Acute Sequelae of COVID-19, COVID Long-Haul
- What is being tested?
- Mind Body Intervention #1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥ 18 years of age)
- Infection with Sars-COV2 (i. e., positive antibody, antigen, or PCR testing)
- Symptoms attributed only to COVID-19 and not to known comorbid disease (e.g., other infections, cancer, etc)
- A somatic symptom score ≥ 10 on the SSS-8 questionnaire with involvement of at least 3 domains
- Symptoms present at least 3 day a week for a minimum of 3 months
- Willingness to engage in a Mind-Body intervention
Who cannot join
- Clear diagnosis of physical disease (e.g. lung fibrosis, myocarditis) not inclusive of non-specific findings such as mild arthritis
- Hospitalization in an intensive care unit for acute COVID-19 infections
- Age greater than 65 years
- Diagnosis of dementia or similar cognitive impairment
- Active addiction disorder (e.g. cocaine) that would interfere with study participation
- Major psychiatric comorbidity (e.g., schizophrenia). Mild to moderate anxiety and depression are not considered in this category
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Ashley Scafetta, 617-754-2882, ascafett@bidmc.harvard.edu
About this study
Official title: Mind Body Intervention for Long COVID
The goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with Long COVID. The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates individual somatic complaints and improves daily functioning, relative to usual care and the active control
- Conditions
- Long COVID, Post-Acute Sequelae of COVID-19, COVID Long-Haul
- Being tested
- Mind Body Intervention #1
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind Body Intervention #1Behavioural
The mind-body intervention will include regular 1 to 2 hour educational sessions and lectures, as well as supplemental reading material. In addition, individualized sessions will be offered each week for students who have additional questions and/or need additional time with the material.
| Study group | Role | What they receive |
|---|---|---|
| Mind Body Intervention #1 | Experimental | Not described Receives: Behavioral: Mind Body Intervention #1 |
| Mind Body Intervention #2 | Active comparator | Not described Receives: Behavioral: Mind Body Intervention #1 |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatic Symptom Score-8 (SSS-8)
Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints. Range of 0-32, with higher scores indicating higher levels of discomfort.
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Secondary outcomes (8)
Short Form Brief Pain Inventory (BPI)
Used to gauge pain intensity, and pain interference with daily function over the duration of the study
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Fatigue Severity Scale (FSS)
Consists of statements relating to a patient's general level of fatigue and fatigue with specific activities. Range of 7-63, with higher scores indicating a higher degree of fatigue.
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
The Multidimensional Dyspnea Profile (MDP)
A survey that assesses perceived physical aspects of dyspnea and associated emotional effects. Each of the rating scales within the MDP is designed to measure a separate construct, though each can be grouped between the two above mentioned domains.
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Generalized Anxiety Disorder form 7 (GAD-7)
Self-report instrument assessing general anxiety over the last two weeks. Each of the 7 item is a statement concerning an anxiety trait, respondents then rate how often that statement is true. Responses range from 0 (not at all) to 3 (nearly every day).
Measured: Baseline and 13 weeks
Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)
a standardized assessment of health-related quality of life
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
End of study measurements
Participants' subjective experience of the program upon completion
Measured: 13 weeks
Pain Anxiety Symptom Score-20 (Pass-20)
Anxiety from pain determined from 20 item survey, with each item being scored from 1-5 in terms of frequency
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Patient Reported Outcomes Measurement Information System Survey for Cognitive Function (PROMIS SF v2.0 cognitive function 8a)
Cognition assessment
Measured: Baseline, 4 weeks, 8 weeks, 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start9 Nov 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
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
- NCT06045338
- Sponsor's protocol ID
- 2023P000529
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind Body Intervention for Long COVID
- ClinicalTrials.gov ID
- NCT06045338
- Acronym / sponsor ID
- 2023P000529
- Conditions
- Long COVID, Post-Acute Sequelae of COVID-19, COVID Long-Haul
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (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 goal of this study is to determine if a mind-body intervention can help people suffering from symptoms associated with Long COVID. The study is a randomized trial examining the effectiveness of a mind body intervention in reducing somatic symptoms from Long COVID in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates individual somatic complaints and improves daily functioning, relative to usual care and the active control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mind Body Intervention #1 | Experimental | Behavioral: Mind Body Intervention #1 |
| Mind Body Intervention #2 | Active comparator | Behavioral: Mind Body Intervention #1 |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (≥ 18 years of age)
- Infection with Sars-COV2 (i. e., positive antibody, antigen, or PCR testing)
- Symptoms attributed only to COVID-19 and not to known comorbid disease (e.g., other infections, cancer, etc)
- A somatic symptom score ≥ 10 on the SSS-8 questionnaire with involvement of at least 3 domains
- Symptoms present at least 3 day a week for a minimum of 3 months
Key exclusion criteria (6 listed)
- Clear diagnosis of physical disease (e.g. lung fibrosis, myocarditis) not inclusive of non-specific findings such as mild arthritis
- Hospitalization in an intensive care unit for acute COVID-19 infections
- Age greater than 65 years
- Diagnosis of dementia or similar cognitive impairment
- Active addiction disorder (e.g. cocaine) that would interfere with study participation
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 Intervention #1The mind-body intervention will include regular 1 to 2 hour educational sessions and lectures, as well as supplemental reading material. In addition, individualized sessions will be offered each week for students who have additional questions and/or need additional time with the material. | Behavioural | Mind Body Intervention #1, Mind Body Intervention #2 |
Primary outcome
Somatic Symptom Score-8 (SSS-8)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
Survey questions pertain to pain, the gastrointestinal system, fatigue, dizziness, and cardiovascular complaints. Range of 0-32, with higher scores indicating higher levels of discomfort.
8 secondary outcomes
Short Form Brief Pain Inventory (BPI)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
Fatigue Severity Scale (FSS)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
The Multidimensional Dyspnea Profile (MDP)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
Generalized Anxiety Disorder form 7 (GAD-7)
Time frame: Baseline and 13 weeks
Patient Reported Outcomes Measurement Information System survey for function disability (PROMIS)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
End of study measurements
Time frame: 13 weeks
Pain Anxiety Symptom Score-20 (Pass-20)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
Patient Reported Outcomes Measurement Information System Survey for Cognitive Function (PROMIS SF v2.0 cognitive function 8a)
Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Long COVID
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
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.
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 Intervention #1 in people with Long COVID and Post-Acute Sequelae of COVID-19, 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 6 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Scafetta (617-754-2882, ascafett@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatic Symptom Score-8 (SSS-8) (time frame: Baseline, 4 weeks, 8 weeks, 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2026.