A Pilot Study for Managing Depressive Symptoms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
1 other identifier
interventional
105
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
1 active site
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 Start
First participant enrolled
June 12, 2026
CompletedFirst Submitted
Initial submission to the registry
July 30, 2026
CompletedFirst Posted
Study publicly available on registry
August 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 12, 2027
August 4, 2026
July 1, 2026
1.1 years
July 30, 2026
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 COMPARATORThe 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)
Digital Neuropathy
EXPERIMENTALThe Digital Neuropathy group will utilize the web-based system (REJUVENATE) for a duration of 20 minutes, 4 times per week (12 weeks)
Capacity Coaching
EXPERIMENTALThe 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
Education attention control will be administered by board certified health and wellness coaches via virtual coaching sessions.
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.
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.
Eligibility Criteria
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
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neera Dahl, MD, PhD
Mayo Clinic
Central Study Contacts
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