RecruitingNot ApplicableNCT07022184

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

A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial


Sponsor

Radboud University Medical Center

Enrollment

216 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (LISDIA) is testing a lifestyle intervention program supported by a smartphone app to help people in the Netherlands who are experiencing depression symptoms and being treated by their general practitioner (GP). **You may be eligible if...** - You are currently experiencing symptoms of depression and have been receiving treatment from your GP or GP mental health worker for less than 6 months - You have a smartphone - You are proficient in Dutch **You may NOT be eligible if...** - You have a severe mental illness such as psychosis or bipolar disorder - You have a severe addiction to alcohol or drugs requiring specialist care - You are at high risk of suicide - You have moderate-to-severe cognitive impairment as determined by your GP Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPersonalized Lifestyle Intervention

The personalized lifestyle intervention (PLI) consists of the combined use of the Patient Journey App (PJA) alongside care provided by the general practitioner or mental health nurse. The Patient Journey App integrates four digital health tools within a single smartphone application: 1. A brief lifestyle questionnaire covering six key areas: mental wellbeing, minimizing harmful substance use, social relationships, healthy eating, sleep, and physical activity. 2. A personalized summary of the questionnaire results, which supports the formulation of two personal lifestyle goals. 3. Tailored information and advice about lifestyle, including suggested interventions, based on the patient's personal goals. 4. Monitoring of depression symptoms over time to support measurement-based care. General practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes.


Locations(3)

Radboudumc

Nijmegen, Gelderland, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

UMC Groningen

Groningen, Provincie Groningen, Netherlands

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NCT07022184


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