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: A pragmatic cluster randomized controlled trial

Purpose Given the public health significance of poorly treatable co-morbid major depressive disorders (MDD) among patients with type 2 diabetes mellitus (DM2) and coronary heart disease (CHD), we need to investigate whether strategies to prevent the development of major depression could reduce its burden of disease. We therefore evaluated the effectiveness of a stepped-care program for subthreshold depression in comparison with usual care in patients with DM2 and/or CHD. Methods A cluster randomized controlled trial, with 27 primary care centers serving as clusters. A total of 236 DM2 and/or CHD patients with subthreshold depression (nine item Patient Health Questionnaire (PHQ-9) score ≥ 6, no current MDD according to DSM-IV criteria) were allocated to the intervention group (N = 96) or usual care group (n = 140). The stepped-care program was delivered by trained practice nurses during one year and consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to the general practitioner. The primary outcome was the 12-month cumulative incidence of MDD as measured with the Mini International Neuropsychiatric Interview (MINI). Secondary outcomes included severity of depression (measured by PHQ-9) at 3, 6, 9 and 12 months. Results Of 236 patients (mean age, 67,5 (SD 10) years; 54.7% men), 210 (89%) completed the MINI at 12 months. The cumulative incidence of MDD was 9 of 89 (10.1%) participants in the intervention group and 12 of 121 (9.9%) participants in the usual care group. We found no statistically significant overall effect of the intervention (OR = 1.21; 95% confidence interval (0.12 to 12.41)) and there were no statistically significant differences in the course or severity of depressive symptoms between the two groups. Conclusions This study suggest that Step-Dep was not more effective in preventing MDD than usual care in a primary care population with DM2 and/or CHD and subthreshold depression

Patients’ and practice nurses’ perceptions of depression in patients with type 2 diabetes and/or coronary heart disease screened for subthreshold depression

Background Comorbid depression is common in patients with type 2 diabetes (DM2) and/or coronary heart disease (CHD) and is associated with poor quality of life and adverse health outcomes. However, little is known about patients’ and practice nurses’ (PNs) perceptions of depression. Tailoring care to these perceptions may affect depression detection and patient engagement with treatment and prevention programs. This study aimed to explore patients’ and PNs’ perceptions of depression in patients with DM2/CHD screened for subthreshold depression. Methods A qualitative study was conducted as part of a Dutch stepped-care prevention project. Using a purposive sampling strategy, data were collected through semi-structured interviews with 15 patients and 9 PNs. After consent, all interviews were recorded, transcribed verbatim and analyzed independently by two researchers with Atlas.ti.5.7.1 software. The patient and PN datasets were inspected for commonalities using a constant comparative method, from which a final thematic framework was generated. Results Main themes were: illness perception, need for care and causes of depression. Patients generally considered themselves at least mildly depressed, but perceived severity levels were not always congruent with Patient Health Questionnaire 9 scores at inclusion. Initially recognizing or naming their mental state as a (subthreshold) depression was difficult for some. Having trouble sleeping was frequently experienced as the most burdensome symptom. Most experienced a need for care; psycho-educational advice and talking therapy were preferred. Perceived symptom severity corresponded with perceived need for care, but did not necessarily match help-seeking behaviour. Main named barriers to help-seeking were experienced stigma and lack of awareness of depression and mental health care possibilities. PNs frequently perceived patients as not depressed and with minimal need for specific care except for attention. Participants pointed to a mix of causes of depression, most related to negative life events and circumstances and perceived indirect links with DM2/CHD. Conclusion Data of the interviewed patients and PNs suggest that they have different perceptions about (subthreshold) depressive illness and the need for care, although views on its causes seem to overlap more

Prescribing ANtiDepressants Appropriately (PANDA):a cluster randomized controlled trial in primary care

<p>Background: Inappropriate use of antidepressants (AD), defined as either continuation in the absence of a proper indication or continuation despite the lack of therapeutic efficacy, applies to approximately half of all long term AD users.</p><p>Methods/design: We have designed a cluster randomized controlled clinical trial to assess the (cost-) effectiveness of an antidepressant cessation advice in the absence of a proper indication for maintenance treatment with antidepressants in primary care. We will select all patients using antidepressants for over 9 months from 45 general practices. Patients will be diagnosed using the Composite International Diagnostic Interview (CIDI) version 3.0, extended with questions about the psychiatric history and previous treatment strategies. General practices will be randomized to either the intervention or the control group. In case of overtreatment, defined as the absence of a proper indication according to current guidelines, a cessation advice is given to the general practitioner. In the control groups no specific information is given. The primary outcome measure will be the proportion of patients that successfully discontinue their antidepressants at one-year follow-up. Secondary outcomes are dimensional measures of psychopathology and costs.</p><p>Discussion: This study protocol provides a detailed overview of the design of the trial. Study results will be of importance for refining current guidelines. If the intervention is effective it can be used in managed care programs.</p>