Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice
NCT ID: NCT07022184
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
216 participants
INTERVENTIONAL
2025-06-17
2027-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Care As Usual (CAU)
The control group, receiving care as usual, will use a version of the Patient Journey App that only displays study questionnaires and sends reminders to complete them at the start of the study, and again at 3 and 6 months. Every 6 weeks, depression symptoms are measured. Patients can view their depression questionnaire results (PHQ-9; Patient Health Questionnaire-9) in a graph within the app. General practitioners and mental health nurses will not have access to the app. At 12 months, all participants will be invited to complete an optional final questionnaire about (cost-)effectiveness to assess the long-term impact of the intervention.
No interventions assigned to this group
Personalized Lifestyle Intervention
The intervention group will receive the personalized lifestyle intervention (PLI) in addition to care as usual. The PLI consists of the combined use of the Patient Journey App and regular treatment provided by the general practitioner or mental health nurse in general practice. Patients, general practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes (symptoms of depression and anxiety). Study questionnaires will be completed at the start of the study (baseline), and again at 3, 6, and optionally 12 months after enrollment. Every 6 weeks, depression symptoms are measured.
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 questionnaire results, which supports the formulation of two personal lifestyle goals.
3. Tailored information and advice about lifestyle, including suggested interventions, based on the patient's personal goals.
4. Monitoring of depression symptoms over time to support measurement-based care.
General practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes.
Interventions
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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 questionnaire results, which supports the formulation of two personal lifestyle goals.
3. Tailored information and advice about lifestyle, including suggested interventions, based on the patient's personal goals.
4. Monitoring of depression symptoms over time to support measurement-based care.
General practitioners and mental health nurses will have access to the app to monitor patient progress and outcomes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a smartphone
* Be proficient in Dutch
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Ixta Noa
UNKNOWN
Hogeschool van Arnhem en Nijmegen (HAN)
UNKNOWN
Pro Persona Mental Health Care Foundation
OTHER
Amsterdam UMC
OTHER
Interactive Studios
UNKNOWN
University Medical Center Groningen
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands
UMC Groningen
Groningen, Provincie Groningen, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Eline Jagtenberg
Role: primary
Otto Maarsingh
Role: primary
Huib Burger
Role: primary
Related Links
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Study website LIDIAS
Other Identifiers
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10930012310037
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-17656
Identifier Type: -
Identifier Source: org_study_id