Autosomal Dominant Polycystic Kidney DiseaseNCT07745920
Managing Depressive Symptoms in ADPKD
A study testing Mayo Clinic-Approved Education, Digital Neuropathy and Capacity Coaching in people with Autosomal Dominant Polycystic Kidney Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- What is being tested?
- Mayo Clinic-Approved Education, Digital Neuropathy and Capacity Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2026to 12 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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))
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Ryan Helland, CCRP, 507-422-3998
About this study
Official title: A Pilot Study for Managing Depressive Symptoms in Autosomal Dominant Polycystic Kidney Disease (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.
- Being tested
- Mayo Clinic-Approved Education, Digital Neuropathy, Capacity Coaching
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mayo Clinic-Approved EducationBehavioural
Education attention control will be administered by board certified health and wellness coaches via virtual coaching sessions.
Digital NeuropathyBehavioural
Also called 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 CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mayo Clinic-Approved Education | Active comparator | 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) Receives: Behavioral: Mayo Clinic-Approved Education |
| Digital Neuropathy | Experimental | The Digital Neuropathy group will utilize the web-based system (REJUVENATE) for a duration of 20 minutes, 4 times per week (12 weeks) Receives: Behavioral: Digital Neuropathy |
| Capacity Coaching | Experimental | 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) Receives: Behavioral: Capacity Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start12 Jun 2026
- Primary completion12 Jul 2027 (estimated)
- Study completion12 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neera Dahl, Mayo Clinic
- Investigators
- Neera Dahl, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745920
- Sponsor's protocol ID
- 25-006463
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Managing Depressive Symptoms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- ClinicalTrials.gov ID
- NCT07745920
- Acronym / sponsor ID
- 25-006463
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 12 Jul 2027 (estimated)
- Study completion
- 12 Jul 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mayo Clinic-Approved Education | Active comparator | Behavioral: Mayo Clinic-Approved EducationThe 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 NeuropathyThe 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 CoachingThe 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mayo Clinic-Approved EducationEducation attention control will be administered by board certified health and wellness coaches via virtual coaching sessions. | Behavioural | Mayo Clinic-Approved Education |
| Digital NeuropathyAlso: REJUVENATEThe 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. | Behavioural | Digital Neuropathy |
| Capacity CoachingBoard 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. | Behavioural | Capacity Coaching |
Primary outcome
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.
1 secondary outcome
Change in the Montgomery-Asberg Depression Rating Scale (MADRS-S) score
Time frame: Baseline, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neera Dahl, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mayo Clinic-Approved Education, Digital Neuropathy and Capacity Coaching in people with Autosomal Dominant Polycystic Kidney Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Helland, CCRP (507-422-3998, RSTTEMPORESGROUP@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual use of intervention (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.