Managing Depressive Symptoms in ADPKD

ConditionAutosomal Dominant Polycystic Kidney Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

105 Participants

are divided into 3 treatment groups

Group A: Mayo Clinic-Approved EducationActive comparator 1 intervention

Group B: Digital NeuropathyExperimental treatment 1 intervention

Group C: Capacity CoachingExperimental treatment 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

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