Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

Personalized lifestyle support with an app for adults seeing their GP for depression symptoms

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

Run by Radboud University Medical Center · NCT07022184 · Data updated 2026-11-12

This study tests whether a smartphone app that supports personalized lifestyle changes can help reduce depression symptoms for adults who visit their GP.

More Depressive Disorder trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment216 (estimated)
SponsorRadboud University Medical Center
Academic / other
Locations3 sites (Nijmegen, Gelderland and 2 other locations)
StatusRecruiting
StartedJune 17, 2025
Main results expectedNovember 2026
Study endsFebruary 2027
Registry record updatedDecember 22, 2025
Trial IDNCT07022184 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults who currently have symptoms of depression and have been receiving treatment for this episode from their GP for less than six months, who speak Dutch and own a smartphone, are the intended participants.

Probably not a fit

People with severe mental illness (e.g., psychosis or bipolar disorder), severe substance addiction requiring specialist care, high suicide risk, moderate-to-severe cognitive impairment, or those without a smartphone or sufficient Dutch are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults presenting to general practice with depressive symptoms are randomized by clinic to receive either usual care or usual care plus a personalized lifestyle intervention delivered via a smartphone app. App users complete a questionnaire covering six themes (mental wellbeing, substance use, social relationships, healthy eating, sleep, and physical activity), set personal goals, and receive tailored guidance and self-monitoring prompts. Outcomes include changes in depression symptoms over time and cost-effectiveness compared with usual care alone. The trial is conducted in multiple Dutch academic centers and embedded in routine primary-care settings.

Why it matters

Potential benefit: If successful, the app could reduce depressive symptoms by helping people make and sustain healthy lifestyle changes while increasing the reach and cost-effectiveness of primary care treatment.

How similar studies have gone: Previous research shows lifestyle changes and digital interventions can help mild-to-moderate depression, but few cluster-randomized trials have tested a personalized lifestyle app embedded in general practice.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Radboudumc
    Nijmegen, Gelderland, Netherlands
    Recruiting
  • Amsterdam UMC
    Amsterdam, North Holland, Netherlands
    Recruiting
  • UMC Groningen
    Groningen, Provincie Groningen, Netherlands
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.