NCT07022184

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive/Anxiety Symptoms
• Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Personalized 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.

Timeline

• Start date: 2025-06-17
• Primary completion: 2026-11-01
• Completion: 2027-02-01
• First posted: 2025-06-15
• Last updated: 2025-12-22

Locations

3 sites across 1 country: Netherlands