NCT07022184

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jun 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jun 2025Feb 2027

First Submitted

Initial submission to the registry

May 22, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 17, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

December 22, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

May 22, 2025

Last Update Submit

December 19, 2025

Conditions

Depressive/Anxiety SymptomsDepressive Disorder

Keywords

Personalized lifestyle interventioneHealthMeasurement-based careDepression symptomatologyCluster randomized trialGeneral practiceLifestyle changesMental health supportPrimary care

Outcome Measures

Primary Outcomes (3)

  • Cost-effectiveness of the Personalized Lifestyle Intervention at 6 months after baseline

    To assess the PLI's cost-effectiveness from a societal perspective, the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) will be used. The main outcome in the cost-effectiveness analysis is Quality-Adjusted Life-Years (QALYs) based on the EQ-5D-5L, measuring general quality of life. Also, additional treatments are measured within the TIC-P, for secondary analysis on additional care.

    Baseline to 6 months

  • Change in quality of life using the EQ-5D-5L

    Change in quality of life will be assessed using the EQ-5D-5L. This tool consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each rated on a 5-level scale. The EQ-5D-5L also includes a visual analog scale (VAS) to assess overall health. Higher scores indicate better quality of life, while lower scores reflect greater limitations or discomfort. This measure helps track changes in health status and overall quality of life over time.

    Baseline to 6 months

  • Change from baseline in the mean depression severity score measured by the PHQ-9 at 6 months after baseline

    To evaluate the effectiveness of the PLI on depression symptomatology, general symptoms of depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-reported questionnaire assessing the severity of depression symptomatology. The PHQ-9 is brief, easy to complete, and takes only a few minutes to fill out. The total score ranges from 0 to 27. Scores are interpreted as follows: 0-4 indicates minimal or no depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Higher scores suggest more severe symptoms, and professional treatment is recommended as the score increases.

    Baseline to 6 months.

Secondary Outcomes (12)

  • Change in the severity of anxiety symptoms: GAD-7 (Generalized Anxiety Disorder-7)

    Baseline to 3 , 6 and 12 months

  • Changes in quality of life according to the Recovering Quality of Life (ReQol)

    Baseline to 3, 6 and 12 months

  • Change in use of antidepressants

    Baseline to 3 and 6 months

  • Change in use of anxiolytics

    Baseline to 3 and 6 months

  • Change in lifestyle measures at month 6

    Baseline to 6 months

  • +7 more secondary outcomes

Other Outcomes (7)

  • Socio-demographics at baseline

    At baseline

  • Threatening Experiences: LTE

    At enrollment and at 6 months

  • History of depression and previous psychological treatment

    At baseline

  • +4 more other outcomes

Study Arms (2)

Care As Usual (CAU)

NO INTERVENTION

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.

Personalized Lifestyle Intervention

EXPERIMENTAL

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.

Device: Personalized Lifestyle Intervention

Interventions

Personalized Lifestyle InterventionDEVICE

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.

Also known as: Patient Journey App, Lifestyle App, PLI
Personalized Lifestyle Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

UMC Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepressive Disorder

Condition Hierarchy (Ancestors)

Mental DisordersMood Disorders

Central Study Contacts

Eline Jagtenberg

CONTACT

0652902132eline.jagtenberg@radboudumc.nl

Suzanne Ligthart

CONTACT

suzanne.ligthart@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 15, 2025

Study Start

June 17, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

December 22, 2025

Record last verified: 2025-06

Locations

NL(3)