Personalized lifestyle support with an app for adults seeing their GP for depression symptoms
A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial
NA · Radboud University Medical Center · NCT07022184
This study tests whether a smartphone app that supports personalized lifestyle changes can help reduce depression symptoms for adults who visit their GP.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center (other) |
| Locations | 3 sites (Nijmegen, Gelderland and 2 other locations) |
| Trial ID | NCT07022184 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nijmegen, Gelderland and 2 other locations
- Radboudumc — Nijmegen, Gelderland, Netherlands (RECRUITING)
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (RECRUITING)
- UMC Groningen — Groningen, Provincie Groningen, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Eline Jagtenberg
- Email: eline.jagtenberg@radboudumc.nl
- Phone: 0652902132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depressive/Anxiety Symptoms, Depressive Disorder, Personalized lifestyle intervention, eHealth, Measurement-based care, Depression symptomatology, Cluster randomized trial, General practice