Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice
Recruiting · NCT07022184 · Interventional (participants receive a specific treatment) · Lead sponsor: Radboud University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
3 locations listed.
- Radboudumc - Nijmegen, Gelderland, Netherlands
- Amsterdam UMC - Amsterdam, North Holland, Netherlands
- UMC Groningen - Groningen, Provincie Groningen, Netherlands