Mind Body Intervention for Post-COVID Syndrome

Overseen By Samuel Kukler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Lung fibrosis, Myocarditis, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 13 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mind-body intervention can help people with Long COVID feel better. It compares two different mind-body techniques against usual care to determine which best reduces physical symptoms and improves daily life. The trial seeks participants who have had COVID-19, experience ongoing symptoms at least three days a week for three months, and are open to trying mind-body practices. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that mind-body interventions are generally safe. For Mind Body Intervention #1, studies have examined similar therapies that relieve physical symptoms from mental stress. Past research found these therapies well-tolerated, with few serious side effects reported. Participants often experience minor issues like tiredness or headaches, common in many treatments.

For Mind Body Intervention #2, previous studies on mind-body programs for Long COVID have shown that participants can complete these programs without major problems. Like Mind Body Intervention #1, these programs have not been linked to serious side effects.

Although detailed safety data for both interventions is limited, available research suggests they are safe and well-tolerated. The "Not Applicable" phase of this study indicates that earlier research has established some level of safety. Always consult a doctor about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for post-COVID syndrome primarily focus on managing symptoms with medications such as anti-inflammatory drugs, antidepressants, or physical therapy. However, Mind Body Intervention #1 stands out because it integrates mental and physical practices to potentially address both the physical and psychological symptoms of post-COVID syndrome holistically. Researchers are excited about these interventions because they aim to enhance overall well-being and could offer a non-pharmaceutical approach, reducing reliance on medication and its potential side effects. Additionally, these interventions may provide a more personalized approach, catering to the individual needs of patients, unlike the one-size-fits-all nature of many current treatments.

What evidence suggests that this trial's mind-body interventions could be effective for Long COVID?

Research has shown that Mind Body Intervention #1, which participants in this trial may receive, includes therapy to relieve physical symptoms and can help reduce symptoms in people with post-acute COVID conditions. Studies have found that this method may lessen the overall symptom load for those with Long COVID. Meanwhile, Mind Body Intervention #2, another treatment option in this trial, also shows promise. In a small study, participants reported improved emotional well-being during the COVID-19 pandemic. This suggests it might also help with the emotional and mental challenges of Long COVID. Both treatments in this trial address different aspects of the syndrome, offering a well-rounded approach to managing symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Michael W Donnino, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had COVID-19, as confirmed by a test, and are now experiencing Long COVID symptoms. They should have these symptoms on most days for at least three months and be willing to try a mind-body intervention. People with other serious diseases causing similar symptoms can't join.

Inclusion Criteria

My symptoms are only due to COVID-19, not any other illness.

I experience significant physical symptoms affecting at least three areas of my body.

You have been infected with the Sars-COV2 virus, as evidenced by a positive antibody, antigen, or PCR test result.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mind-body intervention to reduce somatic symptoms from Long COVID

13 weeks

Regular visits at baseline, 4 weeks, 8 weeks, and 13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mind Body Intervention #1

Trial Overview The study tests if a specific mind-body intervention can reduce the physical symptoms of Long COVID compared to usual care or another mind-body technique. It also looks at whether it helps improve daily functioning.

How Is the Trial Designed?

Group I: Mind Body Intervention #1 Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Group III: Mind Body Intervention #2 Active Control 1 Intervention

Mind Body Intervention #1 is already approved in United States for the following indications:

Approved in United States as Mind Body Intervention #1 for:

• Long COVID symptoms
• Somatic symptoms reduction
• Improvement in daily functioning

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

A neuropsychological rehabilitation program for post-COVID-19 syndrome significantly improved cognitive functions such as working memory and verbal fluency in 123 patients, with 74% experiencing cognitive impairment before treatment.

Despite these improvements, many patients (44.9%) were still unable to return to their pre-COVID-19 work activities six months after treatment, indicating that full recovery of functional levels may not be achieved for all.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neuropsychological rehabilitation for post-COVID-19 syndrome: Results of a clinical program and six-month follow up.] García-Molina, A., García-Carmona, S., Espiña-Bou, M., et al.[2023]

Post-COVID patients experience less psychological distress compared to psychosomatic and psychocardiological patients, with lower average scores on the Beck Depression Inventory (BDI-II) during rehabilitation.

Rehabilitation significantly improved symptoms and physical function in post-COVID patients, with notable increases in self-efficacy and walking distance, and no patients experienced post-exercise malaise, indicating a safe and effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First results from post-COVID inpatient rehabilitation. Kupferschmitt, A., Langheim, E., Tüter, H., et al.[2023]

A multimodal treatment approach combining psychotherapy and exercise therapy shows promise for managing post-COVID syndrome, which affects 5-10% of those infected with SARS-CoV-2 in Germany.

The dual internal psychosomatic rehabilitation concept, which includes behavioral therapy, respiratory training, and cognitive support, has been well accepted by patients and appears effective in helping them cope with illness and improve their performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Only Multimodal, but also Interdisciplinary: A Concept for Interdisciplinary Cooperation in the Rehabilitation of Post-COVID Syndrome]. Kupferschmitt, A., Etzrodt, F., Kleinschmidt, J., et al.[2023]

A community-based Long Covid support service combining psycho-educational and mind-body approaches showed positive outcomes, with participants reporting improvements in mental, physical, emotional, and spiritual wellbeing as measured by the Warwick Holistic Health Questionnaire.

Out of 25 participants, 16 showed significant improvement in their wellbeing scores after engaging with the service, indicating that this complementary approach is beneficial for individuals experiencing health challenges from Long Covid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A service evaluation of a community project combining psychoeducation and mind-body complementary approaches to support those with long covid in the UK. Brough, DN., Abel, S., Priddle, L.[2023]

A neuropsychological rehabilitation program for post-COVID-19 syndrome significantly improved cognitive functions such as working memory and verbal fluency in 91 patients with cognitive impairment, highlighting its efficacy in addressing cognitive-emotional deficits.

Despite these improvements, a follow-up six months later revealed that nearly 45% of patients were still unable to return to their pre-COVID-19 work activities, indicating that full recovery of functional levels may not be achieved for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological rehabilitation for post-COVID-19 syndrome: results of a clinical programme and six-month follow up. García-Molina, A., García-Carmona, S., Espiña-Bou, M., et al.[2023]

Psychophysiologic symptom relief therapy (PSRT) significantly reduced somatic symptoms in patients with post-acute sequelae of COVID-19 (PASC), with improvements measured at 4, 8, and 13 weeks after treatment, showing a mean decrease of 10.9 points on the Somatic Symptom Scale-8 by week 13.

The study, involving 23 adults who had PASC for at least 12 weeks, also reported significant improvements in secondary symptoms like dyspnea, fatigue, and pain, indicating that PSRT may be an effective intervention for managing PASC symptoms without evidence of organ injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychophysiologic Symptom Relief Therapy (PSRT) for Post-acute Sequelae of COVID-19. Donnino, M., Howard, P., Mehta, S., et al.[2023]

This study will evaluate the effectiveness of a cognitive-behavioral therapy called the Unified Protocol for treating anxiety and depression in 60 patients with post COVID-19 syndrome and comorbid emotional disorders, using a unique n-of-1 trial design that allows each participant to serve as their own control.

The intervention consists of 8 online sessions, and outcomes will be assessed for anxiety, depression, and quality of life, with follow-ups extending up to 12 months, aiming to provide insights into the acceptability and clinical utility of psychological treatments for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unified Protocol for the transdiagnostic treatment of emotional disorders in people with post COVID-19 condition: study protocol for a multiple baseline n-of-1 trial. Martínez-Borba, V., Martínez-García, L., Peris-Baquero, Ó., et al.[2023]

This pilot randomized clinical trial aims to evaluate the feasibility and participant satisfaction of a 10-week cognitive behavioral therapy combined with acceptance and commitment therapy (CBT-ACT) for COVID-19 survivors experiencing anxiety and depression symptoms one year after hospitalization.

The study will assess whether this intervention can improve mental health outcomes, including anxiety, depression, post-traumatic stress, and health-related quality of life, in a population that currently lacks effective treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy and Acceptance and Commitment Therapy (CBT-ACT) vs. Standard Care After Critical Illness Due to COVID-19: Protocol for a Pilot Randomized Controlled Trial. Håkansson, A., Cronhjort, M., Lidin-Darlington, P., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06045338

NCT06045338 | Mind Body Intervention for Long COVID-19 ... results submission deadline (generally one year after the primary completion date). ... Mind Body Intervention #1, Intervention/Treatment, Behavioral : Mind Body ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11172229/

A Pilot Pre-Post Interventional Study - PMC In the post-observation period, data were analyzed, and participants were followed-up one-week post-intervention. The scales were repeated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10196153/

Psychophysiologic Symptom Relief Therapy for Post-Acute ... To determine if psychophysiologic symptom relief therapy (PSRT) will reduce symptom burden in patients suffering from post-acute sequelae of coronavirus ...

4. medrxiv.org medrxiv.org/content/10.1101/2022.10.07.22280732v1.full-text

Psychophysiologic symptom relief therapy (PSRT) for post- ... One explanation that incorporates both a physical and psychological conceptual model is a psychophysiologic response or syndrome.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022399925000121

Psychotherapy in patients with long/post-COVID These data included 1) population characteristics including age, sex, sample size, and long/post-COVID criterion, 2) inclusion and exclusion criteria 3) somatic ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828267

Brief Outpatient Rehabilitation Program for Post–COVID-19 ... Participants were randomized in a 1:1 ratio to either the intervention or CAU group. ... Psychophysiologic symptom relief therapy (PSRT) for post-acute sequelae ...

7. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/mind_body_longcovid

Virtual Mind Body Intervention for COVID-19 Long Haul ... Participants must have persistence of symptoms for a least 1 month with no identified organic etiology, and symptoms present at least 4 days a week.