Recruiting

DNT & CC

Sponsor:

Mayo Clinic

Code:

NCT07745920

Conditions

Autosomal Dominant Polycystic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Mayo Clinic-Approved Education

Digital Neuropathy

Capacity Coaching

Study Details

Brief summary:

The purpose of this research is to evaluate the feasibility and effectiveness of Digital Neurotherapy (DNT) or Capacity Coaching (CC) for managing symptoms of depression and self reported pain in Autosomal Dominant Polycystic Kidney Disease (ADPKD) compared to education alone.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Study ID

NCT07745920

Start date

Jun 12, 2026

Status verified date

Aug, 2026

Completion date

Jul 12, 2027

Anticipated

Primary completion date

Jul 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Confirmed clinical diagnosis of ADPKD using Pei-Ravine criteria
  • Pre-End Stage Kidney Disease, with Stage 1-5 CKD (eGFR >10 ml/min/1.73m2, with no anticipated dialysis or transplant within 12 months)
  • Clinical or self-diagnosis of depression
  • English-language fluency

Exclusion criteria:

  • Suicidal ideation/unstable mental illness of any kind
  • Lack of access/ability to use internet-based programs
  • eGFR <10 ml/min/1.73m2
  • Anticipated dialysis or transplant within 6 months
  • Prior chronic dialysis
  • Prior organ (liver or kidney) transplant
  • Lack of English language fluency
  • Significant cognitive impairment (Mini Mental Status Exam (MMSE))

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Mayo Clinic-Approved Education

The control group will receive standard of care, Mayo Clinic approved education for a duration of 60 minutes, every 2 weeks for 6 sessions (12 weeks)

experimental: Digital Neuropathy

The Digital Neuropathy group will utilize the web-based system (REJUVENATE) for a duration of 20 minutes, 4 times per week (12 weeks)

experimental: Capacity Coaching

The Capacity Coaching group will participate in calls with a board certified health and wellness coach for a duration of 60 minutes, every 2 weeks, for 6 sessions (12 weeks)

Interventions

Mayo Clinic-Approved Education

Education attention control will be administered by board certified health and wellness coaches via virtual coaching sessions.

Digital Neuropathy

The web-based system (REJUVENATE) consists of a set of cognitive exercises continuously and automatically adjusted in difficulty based on each user's performance to maintain the balance of challenge and success optimal to promote neuroplastic enhancement of target neural systems.

Capacity Coaching

Board certified health and wellness coaches will create a plan with subjects to use capacity, defined as patients' abilities and resources, to do self-management work.

Primary outcome measure

  • Actual use of intervention [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Ryan Helland, CCRP

507-422-3998RSTTEMPORESGROUP@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Ryan Helland, CCRP

507-422-3998

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-07.