Evaluation of the Effectiveness and Efficiency of a Psychoeducational Group Sessions Intervention Program in the Depressive Episode Realized by Primary Health Care Center Nurses in Barcelona City.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 192
- 试验地点
- 4
- 主要终点
- To measure the symptomatology of the depression by Beck Depression Inventory (BDI) It's a self-administered questionnaire with 21 items (multiple-choice)to measure the intensity, severity and depth of depression.
研究概览
简要总结
The purpose of this study is to compare the effectiveness and efficiency of doing a psychoeducational group program and the conventional treatment versus individual conventional care in patients with a mild/moderate depression disorder,in urban primary healthcare centers in Barcelona city.
详细描述
Nowadays, the depression is one of the public health major issues, this is because of its prevalence and its economic and social repercussions. It is fundamental for the Primary Care to assume the management of these health problems.
Design:A randomised controlled trial of two groups (intervention and control), longitudinal and prospective.
Population of study: The subjects of the study are patients of 20 to 65 years old attended in 8 urban primary healthcare centers of Barcelona city, identified by the general practitioners and nurses with diagnosis of mild/moderate depression disorder according to the BDI scale.
The intervention group receive weekly a psychoeducational group program during 12 weeks run by 2 nurses. The program have a structured content where patient is educated about the illness, pharmacological treatment, the adherence to treatment, diet and physical exercise, problem solving, and cognitive-behavioral therapy.
In the control group the depression in treated as usual with the conventional care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Beck Depression Inventory(BDI)>10 and <
- •Diagnosis of mild/moderate depressive disorders.
- •Signed the Informed Consent.
排除标准
- •Patients diagnosed of severe mental psychiatric disorder,
- •Patients diagnosed of a major depressive disorders,
- •Patients with acute illness or near-terminal medical illness,
- •using secondary mental health services,
- •suicidal ideation or intentions,
- •don't speak and understand spanish or/and catalan language,
- •sensory or cognitive disabilities,
- •illiteracy,
- •does not know or not give consent to participate in the study,
- •temporary residents.
结局指标
主要结局
To measure the symptomatology of the depression by Beck Depression Inventory (BDI) It's a self-administered questionnaire with 21 items (multiple-choice)to measure the intensity, severity and depth of depression.
时间窗: First visit and 3, 6 and 9 months.
次要结局
- To measure the patient's quality of life by the EuroQoL questionnaire; number of visits to primary health care center( doctor and nurse); number of days of labour lost; pharmacological prescription; antidepressant and anxiolytics consumption.(First visit and 3,6 and 9 months)