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

Radboud University Medical Center

Status: Not yet enrolling

Conditions: Depressive/Anxiety Symptoms; Depressive Disorder

Treatments: Device: Personalized Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07022184

2024-17656

10930012310037 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A score of > 5 on the PHQ-9
• 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 < 6 at baseline are allowed to use the PLI, but will not be included in the primary analysis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Care As Usual (CAU)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Personalized Lifestyle Intervention