Managing Depressive Symptoms in ADPKD

NCT07745920 — Not applicable, Recruiting, 105 participants, Mayo Clinic

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

Registry	NCT07745920
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	105 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Autosomal Dominant Polycystic Kidney Disease
Interventions	Mayo Clinic-Approved Education, Digital Neuropathy, Capacity Coaching (Behavioral)
Dates	start 2026-06-12, primary completion 2027-07-12 (estimated), completion 2027-07-12 (estimated), first posted 2026-08-04, last updated 2026-08-07
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Mayo Clinic-Approved Education	Active comparator	Behavioral: 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)
Digital Neuropathy	Experimental	Behavioral: 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)
Capacity Coaching	Experimental	Behavioral: 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)

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), also known as REJUVENATE: 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 (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.

+Outcome measures

Primary outcomes

Actual use of intervention [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

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

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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))

+Locations (1)

Facility	City	Country	Status
Mayo Clinic	Rochester, Minnesota	United States	Recruiting

+Investigators

Neera Dahl, MD, PhD, Principal investigator, Mayo Clinic