Mindfulness + tVNS for Chronic Kidney Disease

(MIND-CKD Trial)

Overseen By Dana DaCosta

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Central α-agonists, MAO inhibitors

Disqualifiers: Severe CKD, Diabetic neuropathy, Autonomic dysfunction, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take central α-agonists or monoamine oxidase (MAO) inhibitors. If you are on these medications, you would need to stop them to participate.

What data supports the effectiveness of the treatment Mindfulness + tVNS for Chronic Kidney Disease?

Research shows that mindfulness-based stress reduction (MBSR) can help reduce stress and improve overall health in people with chronic illnesses, including chronic kidney disease. Additionally, MBSR has been associated with reduced anxiety and improved emotional well-being in various populations. ^{1 2 3 4 5}

Is Mindfulness-based stress reduction (MBSR) safe for humans?

Mindfulness-based stress reduction (MBSR) is generally considered safe for humans and has been widely used in medical settings for over 20 years. Some participants may experience restlessness, physical pain, or difficult emotions during the process, but it is typically well-tolerated. ^{4 6 7 8 9}

How is the treatment Mindfulness-based stress reduction (MBSR) unique for chronic kidney disease?

Mindfulness-based stress reduction (MBSR) is unique because it is a non-drug therapy that uses meditation to help manage stress and emotions, which can be beneficial for people with chronic illnesses like chronic kidney disease. Unlike traditional treatments that may focus on medication, MBSR offers a holistic approach that can improve overall well-being and reduce stress-related symptoms. ^{2 3 4 6 8}

What is the purpose of this trial?

This trial tests if mindfulness meditation and a device that sends electrical pulses to a nerve can help people with chronic kidney disease. These treatments aim to reduce stress and balance the nervous system, potentially improving heart health.

Research Team

Jeanie Park

Principal Investigator

Emory University

Eligibility Criteria

This trial is for adults with stable chronic kidney disease stages III and IV, without recent heart attacks or strokes, severe CKD, certain nerve conditions, extreme blood pressure levels, heavy substance use, or major surgeries in the past 3 months. Pregnant individuals or those on specific medications like MAO inhibitors are excluded.

Inclusion Criteria

My kidney function is moderately to severely reduced.

My kidney function has been stable for the last 3 months.

Exclusion Criteria

You regularly drink more than two drinks a day if you're a man, or more than one drink a day if you're a woman.

Your hemoglobin level is less than 10 grams per deciliter, which means you have severe anemia.

Your heart beats too slowly, less than 55 times per minute.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to 8 weeks of Mindfulness-Based Stress Reduction (MBSR) or a Health Enhancement Program (HEP), with or without transcutaneous vagus nerve stimulation (tVNS).

8 weeks

8 weekly 2.5-hour group sessions and one day-long retreat

Follow-up

Participants are monitored for changes in sympathetic nerve activity, blood pressure, heart rate, baroreflex sensitivity, and inflammation.

4 weeks

Treatment Details

Interventions

• Health enhancement program (HEP)
• Mindfulness-based stress reduction (MBSR)
• Sham-transcutaneous Vagus Nerve Stimulation (tVNS)
• Transcutaneous Vagus Nerve Stimulation (tVNS)

Trial Overview The study examines if mindfulness meditation can improve nervous system function in CKD patients and whether adding non-invasive vagus nerve stimulation enhances these benefits compared to a sham (fake) treatment.

Participant Groups

Group I: Mindfulness-Based Stress Reduction (MBSR) Experimental Treatment 1 Intervention

Mindfulness-Based Stress Reduction (MBSR) tis designed to provide education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. MBSR is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session.

Group II: MBSR+tVNS Experimental Treatment 2 Interventions

Mindfulness-Based Stress Reduction (MBSR) tis designed to provide education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. MBSR is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session. Transcutaneous vagus nerve stimulation (tVNS) is a simple, noninvasive, self-administered adjunctive therapy, that may enhance the sympatho-inhibitory effects of mindfulness meditation (MM) in chronic kidney disease (CKD) .

Group III: HEP+tVNS Experimental Treatment 2 Interventions

Health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP participants will meet with a health educator (a registered dietician) in a group setting for 8 weekly 2.5-hour sessions. Transcutaneous vagus nerve stimulation (tVNS) is a simple, noninvasive, self-administered adjunctive therapy, that may enhance the sympatho-inhibitory effects of mindfulness meditation (MM) in chronic kidney disease (CKD).

Group IV: MBSR+sham-tVNS Active Control 2 Interventions

Mindfulness-Based Stress Reduction (MBSR) tis designed to provide education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. MBSR is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session. Sham stimulation will be delivered using a sham device that is identical in appearance and function to tVNS, but programmed to produce a lower frequency biphasic signal that can be felt by the participant without actually stimulating the vagus nerve.

Group V: Health enhancement program (HEP) Active Control 1 Intervention

Health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP participants will meet with a health educator in a group setting for 8 weekly 2.5-hour sessions with a day-long retreat.

Group VI: HEP+sham-tVNS Active Control 2 Interventions

Health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP participants will meet with a health educator in a group setting for 8 weekly 2.5-hour sessions. Sham stimulation is be delivered using a sham device that is identical in appearance and function to tVNS, but programmed to produce a lower frequency (0.1 Hz) biphasic signal that can be felt by the participant without actually stimulating the vagus nerve.

Mindfulness-based stress reduction (MBSR) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-based stress reduction for:

• Chronic pain
• Anxiety
• Depression
• Stress management

Approved in European Union as Mindfulness-based stress reduction for:

• Chronic pain
• Anxiety
• Depression
• Stress management
• Eating disorders
• Sleep disorders

Approved in Canada as Mindfulness-based stress reduction for:

• Chronic pain
• Anxiety
• Depression
• Stress management

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Mindfulness-based interventions (MBIs) have been shown to significantly improve symptoms of anxiety, depression, self-efficacy, sleep quality, and overall quality of life in patients with chronic kidney disease (CKD) undergoing hemodialysis, based on a review of 6 randomized controlled trials.

MBIs also positively impacted physical health measures such as blood pressure, heart rate, and respiratory rate, suggesting they are a safe and effective complementary therapy for managing CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of mindfulness-based interventions in people undergoing hemodialysis: a systematic review. Razzera, BN., Adamoli, AN., Ranheiri, MF., et al.[2022]

A mindfulness-based stress reduction (MBSR) intervention significantly reduced levels of depression and improved health status in patients with type 2 diabetes over the first year of a 5-year study, with effect sizes of 0.71 and 0.54, respectively.

While the MBSR group experienced notable reductions in psychosocial distress, there were no significant changes in albuminuria levels, indicating that the intervention may primarily benefit mental health rather than directly affecting kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients: design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-study). Hartmann, M., Kopf, S., Kircher, C., et al.[2022]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

Mindfulness-Based Stress Reduction (MBSR) is a program designed to help individuals manage stress and emotions through mindfulness meditation, but current research shows significant methodological issues and a lack of robust evidence regarding its effectiveness.

While there is some preliminary evidence suggesting MBSR may be beneficial, the overall findings do not strongly support its widespread endorsement, indicating a need for more rigorous research to better understand its efficacy and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about mindfulness-based stress reduction? Bishop, SR.[2022]

Mindfulness-Based Stress Reduction (MBSR) significantly decreased anxiety levels in healthcare graduate students after 8 weeks of training, with improvements maintained at 3 weeks post-course.

MBSR also increased empathy among students at the end of the program, although this effect did not persist at the 3-week follow-up, and no significant changes in burnout were observed between the intervention and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. Barbosa, P., Raymond, G., Zlotnick, C., et al.[2013]

The Journeys to Wellness trial successfully adapted the standard 8-week mindfulness-based stress reduction (MBSR) program into a workshop and teleconference format (tMBSR) for 63 kidney transplant candidates, showing high attendance and satisfaction rates among participants.

Participants in the tMBSR group reported significantly higher expectations of the intervention's usefulness for managing their health (83%) compared to the tSupport group (43%), indicating a positive reception and potential efficacy of the mindfulness training for improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. Reilly-Spong, M., Reibel, D., Pearson, T., et al.[2022]

Nurses participating in mindfulness-based stress reduction (MBSR) reported significant benefits, including increased relaxation, improved self-care, and better work and family relationships.

Despite these positive outcomes, participants also faced challenges such as restlessness, physical pain, and managing difficult emotions during the practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based stress reduction on nurse stress and burnout: a qualitative and quantitative study, part III. Cohen-Katz, J., Wiley, S., Capuano, T., et al.[2019]

A systematic review of 18 studies found that Mindfulness Based Stress Reduction (MBSR) therapy significantly improves the conditions of patients with chronic illnesses such as cancer, hypertension, and diabetes.

MBSR offers a promising alternative treatment method that helps patients manage their diseases more effectively, although more research is needed to fully understand its mechanisms and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. Niazi, AK., Niazi, SK.[2022]

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Impacts of mindfulness-based interventions in people undergoing hemodialysis: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients: design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-study). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

What do we really know about mindfulness-based stress reduction? [2022]

5. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based stress reduction on nurse stress and burnout: a qualitative and quantitative study, part III. [2019]

8. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]

9. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]