Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Mental health - Depression
研究概览
简要总结
In Denmark the vast majority of patients with chronic ischemic heart disease and/or type 2 diabetes are managed in general practice. 20% of the patients suffer from poor mental health.
Problem-solving therapy (PST) is a psychotherapeutic method that is proven effective in adults with poor mental health. PST can be provided in general practice.
The main objective of this study is to test effectiveness of providing PST to this group patients.
详细描述
20% of patients with type 2 diabetes and/or chronic ischemic heart disease have poor mental health. Since these patients are managed in general practice interventions targeting poor mental health in these patients should be delivered in here.
Problem-solving therapy (PST) is a well-established psychotherapeutic method that can be delivered by health care providers in general practice.
The main objective of this study is to test the effectiveness of delivering PST for patients with T2D and/or IHS who suffer from poor mental health. We hypothesize that the patients' mental health will be improved after treatment with PST.
Health care providers from 12 general practices are trained in PST and subsequently provide PST for patients with T2D and/or IHS and poor mental health.
Patients are recruited at the annual control visit for the chronic disease. All patients are screened for impaired mental health with the WHO-5 questionnaire. Patients with a score below 50 are offered PST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •+18 years
- •Diagnosed with ischemic heart disease and/or type 2 diabetes
- •Poor mental health defined as WHO-5 well-being index <50 points
排除标准
- •severe mental illness including psychotic disease and suicidal behaviour
- •unable to read and understand Danish
研究组 & 干预措施
Control
Patients in the control group will have unrestricted access to care as usually provided. No restrictions are imposed on the general practitioners (GPs) regarding treatment of patients with mental health problems, as we are interested in assessing the added value of PST in routine clinical practice. In both groups, GPs are recommended to follow the current guidelines.
Intervention
Patients with type 2 diabetes and/or chronic ischemic heart disease are offered up to seven problem solving therapy sessions within a three-month period from inclusion. In both groups, GPs are recommended to follow the current guidelines.
干预措施: Problem Solving Therapy (Behavioral)
结局指标
主要结局
Mental health - Depression
时间窗: 12 months
Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up
次要结局
- Diabetes related stress(12 months)
- Mental health - Depression(6 months)
- Prescriptions of psychopharmacological medications(12 months)
- Health literacy(Baseline)
- Mental health - Anxiety(6 months)
- Use of health care services(Baseline and 12 months)
- Smoking status(Baseline and 12 months)
- Lipid profile(Baseline and 12 months)
- Blood pressure(Baseline and 12 months)
- Medication adherence(Baseline and 12 months)
- Mental health - Anxiety(12 months)