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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness meditation can improve nerve function in people with chronic kidney disease (CKD). It also examines whether adding a simple, non-invasive technique called transcutaneous vagus nerve stimulation (tVNS) can enhance the benefits of mindfulness. Participants will be divided into groups to try either mindfulness with fake tVNS, mindfulness with real tVNS, or a health program with or without tVNS. Those with stage III or IV CKD who have stable kidney function may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing CKD symptoms.

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.

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

Research has shown that mindfulness-based stress reduction (MBSR) is generally safe for people with chronic kidney disease (CKD). It can enhance mental health and quality of life for those with CKD without causing major side effects. Studies also suggest it may help lower blood pressure and improve the body's response to stress.

For transcutaneous vagus nerve stimulation (tVNS), less safety information is available. However, it is a non-invasive method, meaning it doesn't involve surgery or needles. Some studies indicate it might improve brain function and reduce inflammation, suggesting it could be safe, though there is less data specifically for people with heart conditions or CKD.

Both treatments appear to be generally well-tolerated. Participating in a study can provide more information on how these therapies might benefit people with CKD. Always consult a healthcare provider before joining a trial to ensure it is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support individuals with chronic kidney disease (CKD) through mindfulness and nerve stimulation. Unlike standard treatments that often focus on medication and dialysis, this trial combines Mindfulness-Based Stress Reduction (MBSR) with Transcutaneous Vagus Nerve Stimulation (tVNS) to potentially enhance stress management and improve overall health. MBSR introduces participants to mindfulness practices that can reduce stress, while tVNS is a noninvasive technique that could amplify the calming effects of mindfulness by stimulating the vagus nerve. This approach not only targets mental well-being but also explores how these techniques might positively impact kidney health, offering a holistic complement to traditional CKD treatments.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Studies have shown that mindfulness-based stress reduction (MBSR) can benefit people with chronic kidney disease (CKD) by reducing stress and enhancing quality of life. It also helps control blood pressure, crucial for managing CKD. In this trial, some participants will receive MBSR combined with transcutaneous vagus nerve stimulation (tVNS), which research suggests might reduce inflammation and improve symptoms in CKD patients. tVNS has been linked to better mental and physical health in people on dialysis. Together, MBSR and tVNS may enhance the body's ability to manage stress, potentially benefiting those with CKD. Other participants will receive MBSR with sham-tVNS, HEP with tVNS, or HEP with sham-tVNS, allowing for a comprehensive evaluation of these interventions. ^{1 3 5 6 7}

Who Is on the Research Team?

Jeanie Park

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04099992

NCT04099992 | Mindfulness in Chronic Kidney Disease This study tests whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8943880/

Mindfulness Interventions in Hemodialysis: A Review MBIs can offer a promising and safe complementary therapy for people with CKD undergoing hemodialysis, acting on quality of life and physical aspects of the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352013222000138

Mindfulness Meditation on Hemodialysis Patients Mindfulness meditation decreased perceived stress and increased trait mindfulness, emotion regulation, and quality of life in ESRD patients receiving ...

4. medrxiv.org medrxiv.org/content/10.1101/2024.04.17.24306000v1.full-text

Autonomic Modulation with Mindfulness-Based Stress ... Conclusions In this randomized controlled trial, patients with CKD had an amelioration of sympathetic reactivity during mental stress following ...

5. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.16160

Mindfulness for High Blood Pressure: Meta-analysis of RCTs The mindfulness-based stress reduction program (MBSR) may reduce blood pressure (BP) in patients with hypertension or elevated BP.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11015819/

Mental Health and Quality of Life in Chronic Kidney Disease ... MBSR can improve the mental health, sleep quality, and quality of life of CKD patients with mild-to-moderate depression, and improve psychological resilience ...

7. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/10.1113/JP287321

Autonomic modulation with mindfulness‐based stress ... Meaning: These finding suggest that mindfulness training may have clinically beneficial effects on autonomic function in CKD. Introduction.