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

Официальное название

A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial

Обзор

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.

Вмешательства

• Устройство 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 q

Первичные конечные точки

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

Вторичные конечные точки (12)

• Change in the severity of anxiety symptoms: GAD-7 (Generalized Anxiety Disorder-7) [Срок оценки: Baseline to 3 , 6 and 12 months]
• Changes in quality of life according to the Recovering Quality of Life (ReQol) [Срок оценки: Baseline to 3, 6 and 12 months]
• Change in use of antidepressants [Срок оценки: Baseline to 3 and 6 months]
• Change in use of anxiolytics [Срок оценки: Baseline to 3 and 6 months]
• Change in lifestyle measures at month 6 [Срок оценки: Baseline to 6 months]
• Change in BMI [Срок оценки: Baseline to 6 months]
• Change in lifestyle satisfaction measures at month 6 (intervention arm) [Срок оценки: Baseline (intervention only) and 6 months (both groups)]
• Patient satisfaction: CQi (Consumer Quality Index) [Срок оценки: At 6 months]
• Change in patient-doctor relationship: PDRQ-9 [Срок оценки: Baseline to 6 months]
• Change in social support: SSL12 (Social Support List-12) [Срок оценки: Baseline to 6 months]
• PHQ-9 at 3 and 12 months [Срок оценки: Baseline to 6 weeks, 3 months and 12 months]
• Cost-effectiveness at 3 months and at 12 months [Срок оценки: baseline to 3 and 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Нидерланды · 3 центра

• Radboudumc — Nijmegen
• Amsterdam UMC — Amsterdam
• UMC Groningen — Groningen

Публикации

• Jagtenberg EM, Ligthart SA, Muilwijk OG, Akkermans RP, Spoelder M, Burger H, Maarsingh OR, Assendelft WJJ, Hartman TCO. Cost-effectiveness of a smartphone-based personalized lifestyle intervention for symptoms of depression in primary care: protocol for a cluster-randomized controlled trial (LIDIAS). Trials. 2026 May 20;27(1):490. doi: 10.1186/s13063-026-09786-1. PMID 42157297

Идентификаторы

NCT: NCT07022184 · 2024-17656 · 10930012310037

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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