NCT07745920

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jun 2026Jul 2027

Study Start

First participant enrolled

June 12, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2027

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Actual use of intervention

    Actual use of each intervention will be reported as the percentage of eligible subjects participating in the assigned interventions at least twice a week for at least 20 minutes per session.

    12 weeks

Secondary Outcomes (1)

  • Change in the Montgomery-Asberg Depression Rating Scale (MADRS-S) score

    Baseline, 12 weeks

Study Arms (3)

Mayo Clinic-Approved Education

ACTIVE COMPARATOR

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)

Behavioral: Mayo Clinic-Approved Education

Digital Neuropathy

EXPERIMENTAL

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

Behavioral: Digital Neuropathy

Capacity Coaching

EXPERIMENTAL

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)

Behavioral: Capacity Coaching

Interventions

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

Mayo Clinic-Approved Education

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.

Also known as: REJUVENATE
Digital Neuropathy

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.

Capacity Coaching

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Study Officials

  • Neera Dahl, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Helland, CCRP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

June 12, 2026

Primary Completion (Estimated)

July 12, 2027

Study Completion (Estimated)

July 12, 2027

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations