Cost-effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: Design of a cluster-randomized controlled trial

BMC Psychiatry (Impact Factor: 2.21). 05/2013; 13(1):128. DOI: 10.1186/1471-244X-13-128
Source: PubMed


Co-morbid major depression is a significant problem among patients with type 2 diabetes mellitus and/or coronary heart disease and this negatively impacts quality of life. Subthreshold depression is the most important risk factor for the development of major depression. Given the highly significant association between depression and adverse health outcomes and the limited capacity for depression treatment in primary care, there is an urgent need for interventions that successfully prevent the transition from subthreshold depression into a major depressive disorder. Nurse led stepped-care is a promising way to accomplish this. The aim of this study is to evaluate the cost-effectiveness of a nurse-led indicated stepped-care program to prevent major depression among patients with type 2 diabetes mellitus and/or coronary heart disease in primary care who also have subthreshold depressive symptoms.

An economic evaluation will be conducted alongside a cluster-randomized controlled trial in approximately thirty general practices in the Netherlands. Randomization takes place at the level of participating practice nurses. We aim to include 236 participants who will either receive a nurse-led indicated stepped-care program for depressive symptoms or care as usual. The stepped-care program consists of four sequential but flexible treatment steps: 1) watchful waiting, 2) guided self-help treatment, 3) problem solving treatment and 4) referral to the general practitioner. The primary clinical outcome measure is the cumulative incidence of major depressive disorder as measured with the Mini International Neuropsychiatric Interview. Secondary outcomes include severity of depressive symptoms, quality of life, anxiety and physical outcomes. Costs will be measured from a societal perspective and include health care utilization, medication and lost productivity costs. Measurements will be performed at baseline and 3, 6, 9 and 12 months.

The intervention being investigated is expected to prevent new cases of depression among people with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression, with subsequent beneficial effects on quality of life, clinical outcomes and health care costs. When proven cost-effective, the program provides a viable treatment option in the Dutch primary care system.

Trial registration
Dutch Trial Register NTR3715

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Available from: Judith E Bosmans
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    • "Concealed depression among type-2 diabetes patients needs to be assessed in every diabetes care setting. Stepped and collaborative care models for treatment [66,67] of diabetes and depression should be explored for treatment options in Nepal and other low-income countries [23]. Moreover, education about the connection between physical health and mental health, which has been used in high-income settings [68], should be considered for psycho-education programs within this population. "
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    ABSTRACT: Diabetes is a growing health problem in South Asia. Despite an increasing number of studies exploring causal pathways between diabetes and depression in high-income countries (HIC), the pathway between the two disorders has received limited attention in low and middle-income countries (LMIC). The aim of this study is to investigate the potential pathway of diabetes contributing to depression, to assess the prevalence of depression, and to evaluate the association of depression severity with diabetes severity. This study uses a clinical sample of persons living with diabetes sequelae without a prior psychiatric history in urban Nepal. A cross-sectional study was conducted among 385 persons living with type-2 diabetes attending tertiary centers in Kathmandu, Nepal. Patients with at least three months of diagnosed diabetes and no prior depression diagnosis or family history of depression were recruited randomly using serial selection from outpatient medicine and endocrine departments. Blood pressure, anthropometrics (height, weight, waist and hip circumference) and glycated hemoglobin (HbA1c) were measured at the time of interview. Depression was measured using the validated Nepali version of the Beck Depression Inventory (BDI-Ia). The proportion of respondents with depression was 40.3%. Using multivariable analyses, a 1-unit (%) increase in HbA1c was associated with a 2-point increase in BDI score. Erectile dysfunction was associated with a 5-point increase in BDI-Ia. A 10mmHg increase in blood pressure (both systolic and diastolic) was associated with a 1.4-point increase in BDI-Ia. Other associated variables included waist-hip-ratio (9-point BDI-Ia increase), at least one diabetic complication (1-point BDI-Ia increase), treatment non-adherence (1-point BDI-Ia increase), insulin use (2-point BDI-Ia increase), living in a nuclear family (2-point BDI-Ia increase), and lack of family history of diabetes (1-point BDI-Ia increase). Higher monthly income was associated with increased depression severity (3-point BDI-Ia increase per 100,000 rupees, equivalent US$1000). Depression is associated with indicators of more severe diabetes disease status in Nepal. The association of depression with diabetes severity and sequelae provide initial support for a causal pathway from diabetes to depression. Integration of mental health services in primary care will be important to combat development of depression among persons living with diabetes.
    Full-text · Article · Nov 2013 · BMC Psychiatry
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    ABSTRACT: Background Depression is associated with a variety of diabetes complications, including diabetic retinopathy, nephropathy, neuropathy, and macrovascular complications. The prevalence of the symptoms of anxiety (32%) and depression (22.4%) in patients with diabetes is considerably higher than in general population samples (10%). The aim of this study was to evaluate the prevalence and determinants of anxiety and depression symptoms in patients with type 2 diabetes (T2DM). Material/Methods This survey was conducted during 2007–2010. In total, 1500 patients were invited to participate in the study. The Hospital Anxiety and Depression Scale (HADS) was used to measure depression and anxiety for the evaluation of the depressive state and anxiety. Statistical analysis was carried out using SPSS 17.0. Results More than 70% of all respondents who participated in the study had diabetes mellitus complications (72.2%). The prevalence of mild to severe depression score was 28.5% (95% CI 25.7–31.4). The prevalence of anxiety was 42.4% (95% CI 39.3–45.5). Anxiety was more frequent among females (46.8%) than among males (34.7%) (p<0.001). A significant negative trend was observed between prevalence of anxiety and depression, and age and education (p for trend <0.001). Conclusions A significant association between depression and diabetic complications was identified (p<0.05). Duration of diabetes was a risk factor significantly associated with higher scores of anxiety among the patients with T2DM.
    Full-text · Article · Feb 2014 · Medical science monitor: international medical journal of experimental and clinical research
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    ABSTRACT: Background: In stepped care models patients typically start with a low-intensity evidence-based treatment. Progress is monitored systematically and those patients who do not respond adequately step up to a subsequent treatment of higher intensity. Despite the fact that many guidelines have endorsed this stepped care principle it is not clear if stepped care really delivers similar or better patient outcomes against lower costs compared with other systems. We performed a systematic review and meta-analysis of all randomized trials on stepped care for depression. Method: We carried out a comprehensive literature search. Selection of studies, evaluation of study quality and extraction of data were performed independently by two authors. Results: A total of 14 studies were included and 10 were used in the meta-analyses (4580 patients). All studies used screening to identify possible patients and care as usual as a comparator. Study quality was relatively high. Stepped care had a moderate effect on depression (pooled 6-month between-group effect size Cohen's d was 0.34; 95% confidence interval 0.20-0.48). The stepped care interventions varied greatly in number and duration of treatment steps, treatments offered, professionals involved, and criteria to step up. Conclusions: There is currently only limited evidence to suggest that stepped care should be the dominant model of treatment organization. Evidence on (cost-) effectiveness compared with high-intensity psychological therapy alone, as well as with matched care, is required.
    Full-text · Article · Mar 2014 · Psychological Medicine
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