Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Cost-effectiveness of the Personalized Lifestyle Intervention at 6 months after baseline — Baseline to 6 months
  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.
• Change in quality of life using the EQ-5D-5L — Baseline to 6 months
  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.
• Change from baseline in the mean depression severity score measured by the PHQ-9 at 6 months after baseline — Baseline to 6 months.
  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.

Trial sites (3)

More Radboud University Medical Center trials in the Netherlands

Other trials for the same condition