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?

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

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 Mind Body Intervention for Post-COVID Syndrome safe for humans?

The available research suggests that mind-body interventions, including those with psychotherapeutic elements, are generally well accepted by patients and do not report significant safety concerns. These interventions are used in rehabilitation settings and are designed to be adapted to individual capacities, indicating a focus on patient safety. ^{1 2 3 4 5}

How is Mind Body Intervention #1 different from other treatments for post-COVID syndrome?

Mind Body Intervention #1, also known as Psychophysiologic Symptom Relief Therapy, is unique because it focuses on reducing the symptom burden in post-COVID patients without evidence of organ injury, using a mind-body approach that addresses both physical and emotional symptoms, unlike many treatments that primarily target physical symptoms. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Mind Body Intervention #1, Psychophysiologic Symptom Relief Therapy, Mind Body Intervention #1 for Post-COVID Syndrome?

Research suggests that mind-body approaches, like Psychophysiologic Symptom Relief Therapy, may help reduce symptoms in people with post-COVID syndrome by addressing both physical and emotional aspects of their condition. Similar therapies have been used to manage emotional disorders and improve quality of life in post-COVID patients. ^{1 2 4 5 6}

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: Mind Body Intervention #2 Active Control 1 Intervention

Group III: Usual Care 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

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]

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 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]

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]

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 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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Psychophysiologic Symptom Relief Therapy (PSRT) for Post-acute Sequelae of COVID-19. [2023]

2. Switzerland 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

First results from post-COVID inpatient rehabilitation. [2023]

4. Netherlands 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. [2023]

5. Switzerland 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. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

[Not Only Multimodal, but also Interdisciplinary: A Concept for Interdisciplinary Cooperation in the Rehabilitation of Post-COVID Syndrome]. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

[Neuropsychological rehabilitation for post-COVID-19 syndrome: Results of a clinical program and six-month follow up.] [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

Neuropsychological rehabilitation for post-COVID-19 syndrome: results of a clinical programme and six-month follow up. [2023]