Clinical trial NCT07022184: Lifestyle Intervention for Symptoms of Depression wIth App Support in General Practice
Official title: A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive/Anxiety Symptoms
Depressive Disorder
Keywords: Personalized lifestyle intervention
eHealth
Measurement-based care
Depression symptomatology
Cluster randomized trial
General practice
Lifestyle changes
Mental health support
Primary care
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Ixta Noa
name: Hogeschool van Arnhem en Nijmegen (HAN)
name: Pro Persona Mental Health Care Foundation
name: Amsterdam UMC
name: Interactive Studios
name: University Medical Center Groningen
First posted: 2025-06-15
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cost-effectiveness of the Personalized Lifestyle Intervention at 6 months after baseline
timeFrame: Baseline to 6 months
measure: Change in quality of life using the EQ-5D-5L
timeFrame: Baseline to 6 months
measure: Change from baseline in the mean depression severity score measured by the PHQ-9 at 6 months after baseline
timeFrame: Baseline to 6 months.
Secondary outcomes:
measure: Change in the severity of anxiety symptoms: GAD-7 (Generalized Anxiety Disorder-7)
timeFrame: Baseline to 3 , 6 and 12 months
measure: Changes in quality of life according to the Recovering Quality of Life (ReQol)
timeFrame: Baseline to 3, 6 and 12 months
measure: Change in use of antidepressants
timeFrame: Baseline to 3 and 6 months
measure: Change in use of anxiolytics
timeFrame: Baseline to 3 and 6 months
measure: Change in lifestyle measures at month 6
timeFrame: Baseline to 6 months
measure: Change in BMI
timeFrame: Baseline to 6 months
measure: Change in lifestyle satisfaction measures at month 6 (intervention arm)
timeFrame: Baseline (intervention only) and 6 months (both groups)
measure: Patient satisfaction: CQi (Consumer Quality Index)
timeFrame: At 6 months
measure: Change in patient-doctor relationship: PDRQ-9
timeFrame: Baseline to 6 months
measure: Change in social support: SSL12 (Social Support List-12)
timeFrame: Baseline to 6 months
measure: PHQ-9 at 3 and 12 months
timeFrame: Baseline to 6 weeks, 3 months and 12 months
measure: Cost-effectiveness at 3 months and at 12 months
timeFrame: baseline to 3 and 12 months
Other outcomes:
measure: Socio-demographics at baseline
timeFrame: At baseline
measure: Threatening Experiences: LTE
timeFrame: At enrollment and at 6 months
measure: History of depression and previous psychological treatment
timeFrame: At baseline
measure: Chronic diseases: TIC-P
timeFrame: At baseline
measure: Psychiatric comorbidities: LIDAS items (LIfetime Depression Assessment Self-report), adjusted.
timeFrame: Baseline to month 6
measure: Meta-data Patient Journey App during study
timeFrame: At 6 and 12 months
measure: Acceptability and usability of the app: modified MAUQ (intervention arm)
timeFrame: At 6 months (intervention arm only).
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Groningen
country: Netherlands
facility: UMC Groningen
Study officials:
References: