Lifestyle InterVEntion Study in General Practice: LIVES - GP
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Lifestyle coach adoption of GLI-LEEF
研究概览
简要总结
Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease. This may be attributed primarily to an unhealthy lifestyle related to their disorder. Interestingly, the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms, thus creating a hazardous vicious circle. Consequently, there is a great potential for 'Lifestyle Medicine' for depression. Yet, it is known that patients with depression often have motivational and self-management problems. Therefore an 18 session multimodal lifestyle intervention (MLI) specifically tailored to the needs of depressed patients was developed and piloted in mental health care, with promising results. This research aims to investigate using a process evaluation the feasibility of this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply.
详细描述
Rationale: Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease. This may be attributed primarily to an unhealthy lifestyle related to their disorder. Interestingly, the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms, thus creating a hazardous vicious circle. Consequently, there is a great potential for 'Lifestyle Medicine' for depression. Yet, it is known that patients with depression often have motivational and self-management problems. Therefore a multimodal lifestyle intervention (MLI) specifically tailored to the needs of depressed patients was developed and piloted in mental health care, with promising results. This research aims to investigate this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply.
Objective: to estimate in general practice the feasibility of conducting a large-scale study on the effectiveness of a MLI for depression, and identify key factors that can influence its successful conduct. In addition, this study aims to obtain an estimate of the variance of outcome measures (mental health, lifestyle factors, functioning, recovery, wellbeing, sleeping quality, self-esteem, quality of life, health care costs, anthropometry and blood pressure).
Study design: An observational single-group prospective cohort study (n = 50) using mixed methods with baseline measurement and two follow-up measurements: after the intervention at 18 weeks and after a follow-up at 42 weeks.
Study population: Patients (18 years or over) with depression and overweight who are being treated in general practice.
Intervention (if applicable): A MLI named (in Dutch) "Gecombineerde Leefstijl Interventie Leef" (GLI-LEEF), developed for patients with depression consisting of several modules (e.g. on physical activity, healthy diet) comprising both individual and group sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosis of depressive symptoms or depressive disorder in the past year as registered in the general practice electronic health record and coded according to the International Classification of Primary Care (ICPC) as P03 and P76, respectively, or currently treated for depressive symptoms or depressive disorder in general practice.
- •At least mild depressive symptom level according to the Quick Inventory Depressive Symptomatology-Self-Report (QIDS-SR) (score ≥6)
- •Body mass index ≥ 25 kg/m2 or increased waist circumference (>88 cm (women) of >102 cm (men)).
排除标准
- •Current treatment in mental health care (GGZ in Dutch)
- •Severe somatic / neurological disease at the discretion of the GP
- •Currently participating in another lifestyle intervention
- •Insufficient proficiency in Dutch
- •Inability to read and write
结局指标
主要结局
Lifestyle coach adoption of GLI-LEEF
时间窗: 12 months
Lifestyle coach adoption of GLI-LEEF as defined by the number of lifestyle coaches that are willing to implement GLI-LEEF in this study
Barriers and facilitators of the GLI-LEEF implementation
时间窗: 18 weeks
Potential barriers and facilitators of the GLI-LEEF implementation will be identified using a qualitative approach by interviewing approximately 10 participants who dropped out and 10 who completed GLI-LEEF, if opportune
General practice adoption of GLI-LEEF
时间窗: 12 months
General practice adoption of GLI-LEEF as defined by the number of general practices that are willing to implement GLI-LEEF in this study
Adherence to GLI-LEEF
时间窗: 18 weeks
First aspect of implementation is adherence to GLI-LEEF which is defined by the number of sessions attended by the participant out of the total of 18 sessions
General practitioner adoption of GLI-LEEF
时间窗: 12 months
General practice adoption of GLI-LEEF as defined by the number of general practitioners that are willing to implement GLI-LEEF in this study
Reach of GLI-LEEF
时间窗: 12 months
Reach of GLI-LEEF as defined as the number of individuals who are willing to participate in this study
Drop-out from GLI-LEEF
时间窗: 18 weeks
Second aspect of implementation is drop-out from GLI-LEEF which is defined by the proportion of participants who decide to prematurely stop taking part in the intervention
次要结局
- Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Body weight of the participant as assessed by a medical weight scale(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Body height of the participant as assessed by a stadiometer(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Insomnia according to the Insomnia Severity Index (ISI)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Waist circumference of the participant as assessed using a tape meter line(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Self esteem according to the Rosenberg Self-Esteem Scale (RSES)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Diastolic and systolic blood pressure as assessed using a sphygmomanometer(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))
- Quality of life according to the Recovering Quality of Life (ReQol)(Baseline, at the end of the intervention (18 weeks), and at the 6 months follow up (42 weeks after baseline))