Effectiveness of a Psychoeducational Group Intervention Conducted by Primary Health Care Nurses in Patients With Depression and Physical Comorbidity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 504
- 试验地点
- 2
- 主要终点
- Changes in rate of remission of depression
研究概览
简要总结
The primary aim is to evaluate the effectiveness of an intervention based on a psychoeducational program carried out by primary care nurses, to improve the rate of remission and response of depression in patients with physical chronic illness (diabetes, COPD, asthma and / or ischemic heart disease). Secondarily, to assess the cost-effectiveness of the intervention, the effectiveness to improve the control of physical pathology, the impact on quality of life and the feasibility of the intervention.
Methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up evaluation. Economic evaluation study. We will study 504 patients (252 in each group), over 50 years assigned to 25 primary care teams (PC) from Catalonia (urban, semi-urban and rural) with major depression and with at least one of the diseases: diabetes mellitus type 2, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. They will be distributed randomly into two groups. The intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from PC, consisting of health education on chronic physical illness and depressive symptoms.
Main measurements: clinical remission of depression and / or response to intervention (Beck depression inventory: BDI-II). Secondary measures: improvement in control of chronic disease (blood test and physical parameters), drug compliance (test Morinsky-Green and number of packaging), quality of life (EQ-5D), medical service utilization (appointments and hospital admissions due to complications) and feasibility of the intervention (satisfaction and compliance). Evaluations will be masked and conducted at 0, 3 and 12 months. At 6 months, patients will receive a call from nurses.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least one of the following diseases: type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease.
- •Meet major depression criteria at the time of the study: Score above 13 on the BDI-II scale.
- •Possibility of follow-up of one year by the same primary care team.
- •At least read and write Spanish or Catalan.
排除标准
- •Diagnosis of dementia or moderate or high cognitive impairment (5 or more errors according to the pfeiffer scale).
- •Major depression with psychotic symptoms or with other serious psychiatric comorbidities.
- •Moderate or high risk of suicide (6 or more points on the MINI suicide scale).
- •Dependency disorders due to alcohol or other drug abuse.
- •Advanced stage physical disease.
- •Inability to travel to the center.
- •Be receiving some psychological therapy by the Center of mental health (CSM) of reference
研究组 & 干预措施
Control Group
Usual clinical care
Intervention Group
The intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from Primary Care, consisting of health education on chronic physical illness and depressive symptoms.
Group psychoeducation.
干预措施: Group psychoeducation (Behavioral)
结局指标
主要结局
Changes in rate of remission of depression
时间窗: At 12 months of follow-up
Changes in the score of the BDI-II scale
次要结局
- Quantification of the use of services(At 12 months of follow-up)
- Changes in rate of remission of depression(At 3 months of follow-up)
- Changes in the control of asthma(At 12 months of follow-up)
- Changes in the control of Ischemic heart disease(At 12 months of follow-up)
- Satisfaction with the intervention(At 3 months of follow-up)
- Adherence to the intervention(At 3 months of follow-up)
- Changes in the control of COPD(At 12 months of follow-up)
- Qualitative changes of the state of health at the end of the intervention(At 3 and 12 months of follow-up)
- Changes in the control of DM2(At 12 months of follow-up)
- Record of therapeutic compliance(At 12 months of follow-up)
- Referrals to mental health(At 12 months of follow-up)
- Changes in the quality of life(At 12 months of follow-up)
- Qualitative changes of the state of mind at the end of the intervention(At 3 and 12 months of follow-up)