A Personalized Lifestyle Intervention for Depression Symptomatology in General Practice - a Cluster Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 6
- 主要终点
- Cost-effectiveness of the Personalized Lifestyle Intervention at 6 months after baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Cost-effectiveness of the Personalized Lifestyle Intervention at 6 months after baseline
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Change in BMI(Baseline to 6 months)
- Change in lifestyle satisfaction measures at month 6 (intervention arm)(Baseline (intervention only) and 6 months (both groups))
- Patient satisfaction: CQi (Consumer Quality Index)(At 6 months)
- Change in patient-doctor relationship: PDRQ-9(Baseline to 6 months)
- Change in social support: SSL12 (Social Support List-12)(Baseline to 6 months)
- PHQ-9 at 3 and 12 months(Baseline to 6 weeks, 3 months and 12 months)
- Cost-effectiveness at 3 months and at 12 months(baseline to 3 and 12 months)