Mindfulness in Chronic Kidney Disease (MIND-CKD)
Chronic Kidney Diseases
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Mindfulness, Transcutaneous Vagus Nerve Stimulation, tVNS, Sympatho-inhibitory effects
Eligibility Criteria
Inclusion Criteria:
- stages III and IV CKD as defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
- stable renal function (no greater than a decline of eGFR of 1 cc/min/1.73 m2 per month over the prior 3 months)
Exclusion Criteria:
- severe CKD (eGFR<15 cc/min)
- diabetic neuropathy
- autonomic dysfunction
- any serious disease that might influence survival
- anemia with hemoglobin <10 g/dL
- treatment with central α-agonists or monoamine oxidase (MAO) inhibitors
- myocardial infarction or cerebrovascular accident within the past 6 months
- uncontrolled hypertension (BP≥170/100 mm Hg)
- low BP (BP<100/50 mm Hg)
- bradycardia (HR<55 beats/min)
- ongoing drug or alcohol abuse (defined as >2 drinks/day in men, and >1 drink/day in women)
- surgery within the past 3 months
- adjustment of antihypertensive medications within the past month
- pregnancy or plans to become pregnant
- psychosis
- suicidal ideation
- implanted electronic or metallic device such as a pacemaker
- implanted hearing aid, bone plate, carotid stent, bone screw at or near the neck
- carotid atherosclerosis
- concurrent use of another stimulating device such as a transcutaneous electrical nerve stimulation (TENS) unit.
Sites / Locations
- Atlanta VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Mindfulness-Based Stress Reduction (MBSR)
Health enhancement program (HEP)
MBSR+tVNS
MBSR+sham-tVNS
HEP+tVNS
HEP+sham-tVNS
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.
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.
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) .
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.
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).
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.