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Recruiting NCT07745920

Managing Depressive Symptoms in ADPKD

No phase Interventional Autosomal Dominant Polycystic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mayo Clinic-Approved Education, Digital Neuropathy, Capacity Coaching.
Who it may be relevant to
Registry conditions: Autosomal Dominant Polycystic Kidney Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study for Managing Depressive Symptoms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Overview

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.

Interventions

  • Behavioral Mayo Clinic-Approved Education
    Education attention control will be administered by board certified health and wellness coaches via virtual coaching sessions.
  • Behavioral 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.
  • Behavioral 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 measures

  • Actual use of intervention [Time frame: 12 weeks]
Secondary outcome measures (1)
  • Change in the Montgomery-Asberg Depression Rating Scale (MADRS-S) score [Time frame: Baseline, 12 weeks]

Eligibility criteria

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))

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT07745920 · 25-006463

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗