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May 22, 2026Open Access

Cost-effectiveness of a smartphone-based personalized lifestyle intervention for symptoms of depression in primary care: protocol for a cluster-randomized controlled trial (LIDIAS)

Key Points

This study aims to evaluate the cost-effectiveness of a smartphone-based personalized lifestyle intervention for managing depression symptoms in primary care.
Conducting a multicenter, cluster-randomized controlled trial in Dutch general practices.
Randomizing 105 patients per arm into intervention with a personalized eHealth lifestyle app or control using a symptom tracking app.
Assessing primary outcomes using the Patient Health Questionnaire-9 (PHQ-9) and evaluating secondary outcomes related to lifestyle and mental health.
Anticipated improvement in PHQ-9 scores for the intervention group compared to the control group.
Exploration of enhanced patient engagement and satisfaction with treatment in the intervention group.
Evaluation of cost-effectiveness in providing personalized care through a smartphone app.

Abstract

BACKGROUND: Depression is common and mostly managed in primary care. In the Netherlands, general practitioners (GPs) and mental health nurses (GP-MHNs) generally start with education and lifestyle advice, yet the latter remains underused despite evidence of its effectiveness. Smartphone-based eHealth tools may help integrate lifestyle interventions into routine care by offering personalized support and monitoring. This study evaluates the (cost-)effectiveness of a Personalized eHealth Lifestyle Intervention (PLI) delivered via a smartphone app for patients with symptoms of depression in primary care. METHODS: This multicenter, cluster-randomized controlled trial will be conducted in Dutch general practices. Practices will be randomized (1:1), stratified by region and area-level socioeconomic status, into two groups: (1) intervention group including care as usual plus the PLI, or (2) control group including care as usual plus a monitoring app. Within the PLI, patients will use an app for 6 months to set lifestyle goals, monitor progress in lifestyle behavior, and track symptoms of depression and anxiety. GPs and GP-MHNs will have access to patient progress through a web-based version. Control group patients will use a similar app for symptom tracking only. The primary outcome is the change in severity of symptoms of depression assessed with the Patient Health Questionnaire-9 (PHQ-9). Secondary outcomes include lifestyle behaviors, satisfaction with lifestyle, anxiety symptoms, patient satisfaction with treatment by GP and GP-MHNs, mental health-related quality of life, social support, use of antidepressants, use of anxiolytics, and utilization of medical and mental health services. Cost-effectiveness will also be evaluated. A total of 105 patients per arm (PHQ-9 ≥ 5) will be recruited. DISCUSSION: The results of this study will provide valuable insights into the clinical and economic impact of a digital lifestyle support tool. This trial aims to contribute to more accessible, personalized, sustainable, and cost-effective care for people with symptoms of depression in primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT07022184. Registered on June 22, 2025.

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Cite This Study

Jagtenberg et al. (Wed,) studied this question.

synapsesocial.com/papers/6a0ff2f5d674f7c03778b5a7 https://doi.org/https://doi.org/10.1186/s13063-026-09786-1

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