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

RecruitingNAAges 18 Years - anyAllRadboud University Medical Center
NCT07022184 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 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 \<5 at baseline are allowed to use the PLI, but will not be included in the primary analysis.
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What it tests

  • Personalized Lifestyle Intervention
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Where

3 sites
Radboudumc
Nijmegen, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
UMC Groningen
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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