Patients with severe mental illness have higher prevalences of cardiovascular risk factors (CRF). The objective is to determine whether interventions to modify lifestyles in these patients reduce anthropometric and analytical parameters related to CRF in comparison to routine clinical practice. Systematic review of controlled clinical trials with lifestyle intervention in Medline, Cochrane Library, Embase, PsycINFO and CINALH. Change in body mass index, waist circumference, cholesterol, triglycerides and blood sugar. Meta-analyses were performed using random effects models to estimate the weighted mean difference. Heterogeneity was determined using i(2) statistical and subgroups analyses. 26 studies were selected. Lifestyle interventions decrease anthropometric and analytical parameters at 3 months follow up. At 6 and 12 months, the differences between the intervention and control groups were maintained, although with less precision. More studies with larger samples and long-term follow-up are needed.
Background
Depressive disorders are the third leading cause of consultation in primary care, mainly in patients with chronic physical illnesses. Studies have shown the effectiveness of group psychoeducation in reducing symptoms in depressive individuals. Our primary aim is to evaluate the effectiveness of an intervention based on a psychoeducational program, carried out by primary care nurses, to improve the remission/response rate of depression in patients with chronic physical illness. Secondarily, to assess the cost-effectiveness of the intervention, its impact on improving control of the physical pathology and quality of life, and intervention feasibility.
Methods/design
A multicenter, randomized, clinical trial, with two groups and one-year follow-up evaluation. Economic evaluation study.
Subjects
We will assess 504 patients (252 in each group) aged > 50 years assigned to 25 primary healthcare centers (PHC) from Catalonia (urban, semi-urban, and rural). Participants suffer from major depression (Beck depression inventory: BDI-II 13–28) and at least one of the following: type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, and/or ischemic cardiopathy. Patients with moderate/severe suicide risk or severe mental disorders are excluded. Participants will be distributed randomly into the intervention group (IG) and control (CG).
Intervention
The IG will participate in the psychoeducational intervention: 12 sessions of 90 min, once a week led by two Primary Care (PC) nurses. The sessions will consist of health education regarding chronic physical illness and depressive symptoms.
Main measurements
Clinical remission of depression and/or response to intervention (BDI-II).
Secondary measurements
Improvement in control of chronic diseases (blood test and physical parameters), drug compliance (Morinsky-Green test and number of containers returned), 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 blinded, and conducted at baseline, post-intervention, and 12 months follow-up.
Discussion
Results could be informative for efforts to prevent depression in patients with a chronic physical illness.
Trial registration
NCT03243799
(registration date August 9, 2017)
The association between physical illness and depression implies a poorer management of chronic disease and a lower response to antidepressant treatments. Our study evaluates the effectiveness of a psychoeducational group intervention led by Primary Care (PC) nurses, aimed at patients of this kind. It is a randomized, multicenter clinical trial with intervention (IG) and control groups (CG), blind response variables, and a one year follow-up. The study included 380 patients ≥50 years of age from 18 PC teams. The participants presented depression (BDI-II > 12) and a physical comorbidity: diabetes mellitus type 2, ischemic heart disease, chronic obstructive pulmonary disease, and/or asthma. The IG (n = 204) received the psychoeducational intervention (12 weekly sessions of 90 min), and the CG (n = 176) had standard care. The patients were evaluated at baseline, and at 4 and 12 months. The main outcome measures were clinical remission of depressive symptoms (BDI-II ≤ 13) and therapeutic response (reduction of depressive symptoms by 50%). Remission was not significant at four months. At 12 months it was 53.9% in the IG and 41.5% in the CG. (OR = 0.61, 95% CI, 0.49–0.76). At 4 months the response in the IG (OR = 0.59, 95% CI, 0.44–0.78) was significant, but not at 12 months. The psychoeducational group intervention led by PC nurses for individuals with depression and physical comorbidity has been shown to be effective for remission at long-term and for therapeutic response at short-term.
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