Managing Depressive Symptoms in ADPKD

Mayo Clinic105 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Autosomal Dominant Polycystic Kidney Disease

Interventions

Mayo Clinic-Approved EducationBEHAVIORAL

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

Digital NeuropathyBEHAVIORAL

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 CoachingBEHAVIORAL

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

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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

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

Time frame: Baseline, 12 weeks

Central Contacts

Ryan Helland, CCRP

CONTACT

507-422-3998 RSTTEMPORESGROUP@mayo.edu

Data from ClinicalTrials.gov

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