NCT07022184 Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice
| NCT ID | NCT07022184 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Depressive/Anxiety Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2025-06-17 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2025-06-17 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07022184 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depressive/Anxiety Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07022184 currently recruiting?
Yes, NCT07022184 is actively recruiting participants. Contact the research team at eline.jagtenberg@radboudumc.nl for enrollment information.
Where is the NCT07022184 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Amsterdam, Netherlands, Groningen, Netherlands.
Who is sponsoring the NCT07022184 clinical trial?
NCT07022184 is sponsored by Radboud University Medical Center. The trial plans to enroll 216 participants.
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