Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07022184

Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice

Led by Radboud University Medical Center · Updated on 2025-12-22

216

Participants Needed

3

Research Sites

84 weeks

Total Duration

On this page

Sponsors

R

Radboud University Medical Center

Lead Sponsor

I

Ixta Noa

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to find out whether a smartphone app can help reduce symptoms of depression by supporting healthy lifestyle changes and encouraging self-monitoring in adults who visit their general practitioner with symptoms of depression. The main questions this study aims to answer are: Does a personalized lifestyle intervention delivered through the app, in addition to regular care, reduce depression symptoms more effectively than regular care alone? Is this approach more cost-effective than regular care alone? Researchers will compare patients who use the app alongside their regular care to patients who receive regular care without the app, to see whether the app leads to better outcomes. Participants who use the app will: Complete a lifestyle questionnaire focused on six themes: mental wellbeing, use of harmful substances, social relationships, healthy eating, sleep, and physical activity. Set personal goals based on their results and receive tailored lifestyle advice. Track their depression symptoms regularly within the app to support ongoing care. Have follow-up conversations with their general practitioner or mental health nurse to discuss their progress. Fill out questionnaires about their symptoms and experiences during the study.

CONDITIONS

Official Title

Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently experiencing an episode of symptoms of depression and receiving treatment for this episode from their GP or GP-MHW for less than six months
  • Have a smartphone
  • Be proficient in Dutch
Not Eligible

You will not qualify if you...

  • Severe mental illness (such as psychosis or bipolar disorder)
  • Severe alcohol or drug addiction requiring specialized secondary care
  • High suicide risk
  • moderate to severe cognitive impairment (as determined by the GP)

Patients who visit their GP for depressive symptoms but with a PHQ-9 of <5 at baseline are allowed to use the PLI, but will not be included in the primary analysis.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Radboudumc

Nijmegen, Gelderland, Netherlands, 6525GA

Actively Recruiting

2

Amsterdam UMC

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

3

UMC Groningen

Groningen, Provincie Groningen, Netherlands, 9713 GZ

Actively Recruiting

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Research Team

E

Eline Jagtenberg

CONTACT

S

Suzanne Ligthart

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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