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NCT Number: NCT07745920

Managing Depressive Symptoms in ADPKD

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.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Ryan Helland, CCRP

CONTACT

507-422-3998

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

Mayo Clinic-Approved Education

Behavioral

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

Digital Neuropathy

Behavioral

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.

Other names: REJUVENATE

Capacity Coaching

Behavioral

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 outcomes

  1. Actual use of intervention

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: Baseline, 12 weeks

    The Montgomery-Asberg Depression Rating Scale (MADRS-S) is a 9-item patient-administered questionnaire designed to measure the severity of depression. It evaluates symptoms like sadness, tension, sleep, appetite, concentration, and suicidal thoughts, with scores ranging from 0 to 54, where higher scores indicate greater severity

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan Helland, CCRP

CONTACT

[email protected]

507-422-3998

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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