Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized Lifestyle Intervention.
- Who it may be relevant to
- Registry conditions: Depressive/Anxiety Symptoms, Depressive Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial
Overview
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.
Interventions
- Device Personalized Lifestyle Intervention
The personalized lifestyle intervention (PLI) consists of the combined use of the Patient Journey App (PJA) alongside care provided by the general practitioner or mental health nurse. The Patient Journey App integrates four digital health tools within a single smartphone application: 1. A brief lifestyle questionnaire covering six key areas: mental wellbeing, minimizing harmful substance use, social relationships, healthy eating, sleep, and physical activity. 2. A personalized summary of the q
Primary outcome measures
- Cost-effectiveness of the Personalized Lifestyle Intervention at 6 months after baseline [Time frame: Baseline to 6 months]
- Change in quality of life using the EQ-5D-5L [Time frame: Baseline to 6 months]
- Change from baseline in the mean depression severity score measured by the PHQ-9 at 6 months after baseline [Time frame: Baseline to 6 months.]
Secondary outcome measures (12)
- Change in the severity of anxiety symptoms: GAD-7 (Generalized Anxiety Disorder-7) [Time frame: Baseline to 3 , 6 and 12 months]
- Changes in quality of life according to the Recovering Quality of Life (ReQol) [Time frame: Baseline to 3, 6 and 12 months]
- Change in use of antidepressants [Time frame: Baseline to 3 and 6 months]
- Change in use of anxiolytics [Time frame: Baseline to 3 and 6 months]
- Change in lifestyle measures at month 6 [Time frame: Baseline to 6 months]
- Change in BMI [Time frame: Baseline to 6 months]
- Change in lifestyle satisfaction measures at month 6 (intervention arm) [Time frame: Baseline (intervention only) and 6 months (both groups)]
- Patient satisfaction: CQi (Consumer Quality Index) [Time frame: At 6 months]
- Change in patient-doctor relationship: PDRQ-9 [Time frame: Baseline to 6 months]
- Change in social support: SSL12 (Social Support List-12) [Time frame: Baseline to 6 months]
- PHQ-9 at 3 and 12 months [Time frame: Baseline to 6 weeks, 3 months and 12 months]
- Cost-effectiveness at 3 months and at 12 months [Time frame: baseline to 3 and 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Netherlands · 3 centers
- Radboudumc — Nijmegen
- Amsterdam UMC — Amsterdam
- UMC Groningen — Groningen
Publications
- Jagtenberg EM, Ligthart SA, Muilwijk OG, Akkermans RP, Spoelder M, Burger H, Maarsingh OR, Assendelft WJJ, Hartman TCO. Cost-effectiveness of a smartphone-based personalized lifestyle intervention for symptoms of depression in primary care: protocol for a cluster-randomized controlled trial (LIDIAS). Trials. 2026 May 20;27(1):490. doi: 10.1186/s13063-026-09786-1. PMID 42157297
Identifiers
NCT: NCT07022184 · 2024-17656 · 10930012310037