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Search / Trial NCT07022184

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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jun 6, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Personalized Lifestyle Intervention E Health Measurement Based Care Depression Symptomatology Cluster Randomized Trial General Practice Lifestyle Changes Mental Health Support Primary Care

ClinConnect Summary

This clinical trial is exploring whether a smartphone app can help people manage their depression by encouraging healthy lifestyle changes and helping them keep track of their symptoms. The researchers want to find out if using the app along with regular care from a doctor can reduce symptoms of depression more effectively than just receiving regular care alone. They will compare two groups of patients: one group will use the app while continuing their regular treatment, and the other group will receive only standard care without the app.

To be eligible for this trial, participants should be adults aged 65 to 74, have a score over 5 on a depression questionnaire called the PHQ-9, own a smartphone, and be comfortable using Dutch. Participants will complete a questionnaire about their lifestyle, set personal health goals, and track their depression symptoms through the app. They will also have follow-up discussions with their doctor or a mental health nurse to review their progress. This study is not yet recruiting participants, but it aims to understand how effective and cost-efficient this app-based approach can be for managing depression.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • A score of \> 5 on the PHQ-9
  • Have a smartphone
  • Be proficient in Dutch
  • Exclusion Criteria:
  • 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 \< 6 at baseline are allowed to use the PLI, but will not be included in the primary analysis.

About Radboud University Medical Center

Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.

Locations

Groningen, , Netherlands

Amsterdam, , Netherlands

Nijmegen, Gelderland, Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported