Mindfulness + tVNS for Chronic Kidney Disease

(MIND-CKD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jeanie Park

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Emory University

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

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

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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.

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Atlanta VA Medical Center Atlanta, GA

Who Is Running the Clinical Trial?

Emory University Lead Sponsor

National Center for Complementary and Integrative Health (NCCIH) Collaborator

References

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

Impacts of mindfulness-based interventions in people undergoing hemodialysis: a systematic review. [2022] Chronic kidney disease (CKD) is a serious public health problem worldwide, leading to a series of physical and psychological comorbidities, in addition to costly treatments, lifestyle and dietary restrictions. There is evidence that mindfulness-based interventions (MBIs) offer complementary treatment for people with chronic illnesses, including CKD, with the aim of improving overall health, reducing side effects and treatment costs. This review aims to investigate the MBIs impact on people with CKD undergoing hemodialysis, and to identify the methodological quality of the current literature in order to support future studies.

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] To determine whether a mindfulness-based stress reduction (MBSR) intervention is effective for reducing psychosocial distress (i.e., depression, psychosocial stress) and the progression of nephropathy (i.e., albuminuria) and for improving the subjective health status of patients with type 2 diabetes.

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] Mindfulness-based stress reduction (MBSR) is a well-known mindfulness meditation program for patients that also may benefit health care providers and clinic staff themselves. An abbreviated MBSR program adapted into 6 weekly 75-minute sessions held during staff lunch breaks provided a feasible and acceptable staff training approach within the workplace setting.

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

What do we really know about mindfulness-based stress reduction? [2022] Mindfulness-Based Stress Reduction (MBSR) is a clinical program, developed to facilitate adaptation to medical illness, which provides systematic training in mindfulness meditation as a self-regulatory approach to stress reduction and emotion management. There has been widespread and growing use of this approach within medical settings in the last 20 years, and many claims have been made regarding its efficacy. This article will provide a critical evaluation of the available state of knowledge regarding MBSR and suggestions for future research.

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] Graduate healthcare students experience significant stressors during professional training. Mindfulness-Based Stress Reduction (MBSR) is a behavioural intervention designed to teach self-regulatory skills for stress reduction and emotion management. This study examines the impact of MBSR training on students from five healthcare graduate programs in a quasi-experimental trial.

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] Mindfulness-based stress reduction (MBSR) has demonstrated benefits for stress-related symptoms; however, for patients with burdensome treatment regimens, multiple co-morbidities and mobility impairment, time and travel requirements pose barriers to MBSR training.

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] Part III of the study on mindfulness-based stress reduction (MBSR) describes qualitative data and discusses the implications of the findings. Study analysis revealed that nurses found MBSR helpful. Greater relaxation and self-care and improvement in work and family relationships were among reported benefits. Challenges included restlessness, physical pain, and dealing with difficult emotions.

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

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022] Mindfulness Based Stress Reduction (MBSR) therapy is a meditation therapy, though originally designed for stress management, it is being used for treating a variety of illnesses such as depression, anxiety, chronic pain, cancer, diabetes mellitus, hypertension, skin and immune disorders.

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

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019] Mindfulness-based stress reduction (MBSR) is a manualised group intervention using mindfulness training as a means of reducing the suffering associated with physical, psychosomatic and psychiatric illness. A review of the literature includes 31 randomised studies. Results indicate that MBSR may improve mental health and reduce symptoms of stress, anxiety and depression in both clinical and non-clinical populations. Implementation in the health-care system is recommended to take place over time to secure sufficient education of MBSR teachers in Denmark.