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Background: Major depression is a prevalent mental disorder with a high risk of relapse or recurrence. Only few studies have focused on the cost-effectiveness of interventions aimed at the prevention of relapse or recurrence of depression in primary care. Aim: To evaluate the cost-effectiveness of a supported Self-help Preventive Cognitive Therapy (S-PCT) added to treatment-as-usual (TAU) compared with TAU alone for patients with a history of depression, currently in remission. Methods: An economic evaluation alongside a multi-center randomised controlled trial was performed (n = 248) over a 12-month follow-up. Outcomes included relapse or recurrence of depression and quality-adjusted-life-years (QALYs) based on the EuroQol-5D. Analyses were performed from both a societal and healthcare perspective. Missing data were imputed using multiple imputations. Uncertainty was estimated using bootstrapping and presented using the cost-effectiveness plane and the Cost-Effectiveness Acceptability Curve (CEAC). Cost estimates were adjusted for baseline costs. Results: S-PCT statistically significantly decreased relapse or recurrence by 15% (95%CI 3;28) compared to TAU. Mean total societal costs were €2,114 higher (95%CI -112;4261). From a societal perspective, the ICER for relapse or recurrence was 13,515. At a Willingness To Pay (WTP) of 22,000 €/recurrence prevented, the probability that S-PCT is cost-effective, in comparison with TAU, is 80%. The ICER for QALYs was 63,051. The CEA curve indicated that at a WTP of 30,000 €/QALY gained, the probability that S-PCT is cost-effective compared to TAU is 21%. Conclusions: Though ultimately depending on the WTP of decision makers, we expect that for both relapse or recurrence and QALYs, S-PCT cannot be considered cost-effective compared to TAU. [ABSTRACT FROM AUTHOR]

Objective: Evidence exists for the efficacy of collaborative care (CC) for major depressive disorder (MDD), for the efficacy of the consequent use of pain medication against pain, and for the efficacy of duloxetine against both MDD and neuropathic pain. Their relative effectiveness in comorbid MDD and pain has never been established so far. This study explores the effectiveness of CC with pain medication and duloxetine, and CC with pain medication and placebo, compared with duloxetine alone, on depressive and pain symptoms. This study was prematurely terminated because of massive reorganizations and reimbursement changes in mental health care in the Netherlands during the study period and is therefore of exploratory nature. Methods: Three-armed, randomized, multicenter, placebo-controlled trial at three specialized mental health outpatient clinics with patients who screened positive for MDD. Interventions lasted 12 weeks. Pain medication was administered according to an algorithm that avoids opiate prescription as much as possible, where paracetamol, COX inhibitors, and pregabalin are offered as steps before opiates are considered. Patients who did not show up for three or more sessions were registered as non-compliant. Explorative, intention-to-treat and per protocol, multilevel regression analyses were performed. The trial is listed in the trial registration (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1089; NTR number: NTR1089). Results: Sixty patients completed the study. Patients in all treatment groups reported significantly less depressive and pain symptoms after 12 weeks. CC with placebo condition showed the fastest decrease in depressive symptoms compared with the duloxetine alone group (b = -0.78; p = 0.01). Non-compliant patients (n = 31) did not improve over the 12-week period, in contrast to compliant patients (n = 29). Pain outcomes did not differ between the three groups. Conclusion: In MDD and pain, patient's compliance and placebo effects are more important in attaining effect than choice of one of the treatments. Active pain management with COX inhibitors and pregabalin as alternatives to tramadol or other opiates might provide an attractive alternative to the current WHO pain ladder as it avoids opiate prescription as much as possible. The generalizability is limited due to the small sample size. Larger studies are needed. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The Four-Dimensional Symptom Questionnaire (4DSQ) is originally a Dutch 50 item questionnaire developed in primary care to assess distress, depression, anxiety and somatization. We aimed to develop and validate a Turkish translation of the 4DSQ. Methods: The questionnaire was translated using forward and backward translation, and pilot testing. Turkish 4DSQ-data were collected in 352 consecutive adult primary care patients. For comparison, gender and age matched Dutch reference data were drawn from a larger existing dataset. We used differential item and test functioning (DIF and DTF) analysis to validate the Turkish translation to the original Dutch questionnaire. Through additional inquiry we tried to obtain more insight in the background of DIF in some items. Results: Twenty-one items displayed DIF but this impacted only the distress and depression scores. Inquiry among Turkish people revealed that the reason for DTF in the distress scale was probably related to unfavourable socio-economic circumstances. On the other hand, the likely explanation for DTF in the depression scale appeared to be grounded in culturally and religiously determined optimistic beliefs. Raising the distress cut-offs by 2 points and lowering the depression cut-offs by 1 point ensures that individual Turkish 4DSQ scores be correctly interpreted. Conclusions: The Turkish translation of the 4DSQ (named: "Dört-Boyutlu Yakınma Listesi", 4BYL) measures the same constructs as the original Dutch questionnaire. Turkish anxiety and somatization scores can be interpreted in the same way as Dutch scores. However, when interpreting Turkish distress and depression scores, DTF should be taken into account. [ABSTRACT FROM AUTHOR]

Chronic pain is commonly co-morbid with a depressive or anxiety disorder. Objective of this study is to examine the influence of depression, along with anxiety, on pain-related disability, pain intensity, and pain location in a large sample of adults with and without a depressive and/or anxiety disorder. The study population consisted of 2981 participants with a depressive, anxiety, co-morbid depressive and anxiety disorder, remitted disorder or no current disorder (controls). Severity of depressive and anxiety symptoms was also assessed. In separate multinomial regression analyses, the association of presence of depressive or anxiety disorders and symptom severity with the Chronic Pain Grade and location of pain was explored. Presence of a depressive (OR = 6.67; P<.001), anxiety (OR = 4.84; P<.001), or co-morbid depressive and anxiety disorder (OR = 30.26; P<.001) was associated with the Chronic Pain Grade. Moreover, symptom severity was associated with more disabling and severely limiting pain. Also, a remitted depressive or anxiety disorder showed more disabling and severely limiting pain (OR = 3.53; P<.001) as compared to controls. A current anxiety disorder (OR = 2.96; p<.001) and a co-morbid depressive and anxiety disorder (OR = 5.15; P<.001) were more strongly associated with cardio-respiratory pain, than gastro-intestinal or musculoskeletal pain. These findings remain after adjustment for chronic cardio respiratory illness. Patients with a current and remitted depressive and/or anxiety disorder and those with more severe symptoms have more disabling pain and pain of cardio-respiratory nature, than persons without a depressive or anxiety disorder. This warrants further research. [ABSTRACT FROM AUTHOR]

Background Depressive symptoms are highly prevalent in old age, but they remain mostly untreated. Several clinical trials have shown promising results in preventing or reducing depressive symptoms. However, it is not clear how robust these effects are in the real world of day-today care. Therefore, we have implemented the 'Lust for Life' programme, which significantly reduced depressive symptoms in community-dwelling older adults in the first three months after implementation. This mixed-methods study was conducted alongside the trial to develop a contextualised understanding of factors affecting the implementation. Methods A total of 263 persons of 65 years and older with depressive symptoms were recruited from 18 general practices and home care organizations in the Netherlands. We used qualitative data (in-depth interviews and focus group discussions with participants with depressive symptoms and healthcare professionals) as well as quantitative data (longitudinal data on the severity of depressive symptoms) to explore hindering and facilitating factors to the implementation of the 'Lust for Life' programme. Results The uptake of the routine screening was poor and imposed significant burdens on participants and healthcare professionals, and drop-out rates were high. Participants' perceived mental problems and need for care played a key role in their decision to participate in the programme and to step up to consequent interventions. Older people preferred interventions that focused on interpersonal contact. The programme was only effective when delivered by mental healthcare nurses, compared to home care nurses with limited experience in providing mental healthcare. Conclusions The intervention programme was effective in reducing depressive symptoms, and valuable lessons can be learned from this implementation trial. Given the low uptake and high investment, we advise against routine screening for depressive symptoms in general healthcare. Further, agreement between the participant and healthcare professional on perceived need for care and intervention is vital. Rather than providing a stepped care intervention programme, we showed that offering only one single preference-led intervention is effective. Lastly, since the provision of the interventions seems to ask for specific skills and experiences, it might require mental healthcare nurses to offer the programme. [ABSTRACT FROM AUTHOR]

Background: The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied. This article describes the aims and design of a study to evaluate effects and costs of collaborative care with the antidepressant duloxetine for patients with pain symptoms and a depressive disorder, compared to collaborative care with placebo and compared to duloxetine alone. Methods/Design: This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. In the collaborative care conditions a) and b), a care-manager provides Problem Solving Treatment and integrated symptom management guidance with a self-help manual, monitors depressive and pain symptoms, and refers patients to a physiotherapist for treatment according to a 'Graded Activity' protocol. A psychiatrist provides duloxetine or placebo and pain medication according to algorithms, and also monitors pain and depressive symptoms. In condition c), the psychiatrist prescribes duloxetine without collaborative care. After 12 weeks, the patient is referred back to the general practitioner with a consultation letter, with information for further treatment of the patient. Discussion: This study enables us to show the value of a closely monitored integrated treatment model above usual pharmacological treatment. Furthermore, a comparison with a placebo arm enables us to evaluate effectiveness of duloxetine in this population in a real life setting. Also, this study will provide evidence-based treatments and tools for their implementation in practice. This will facilitate generalization and implementation of results of this study. Moreover, patients included in this study are screened for pain symptoms, differentiating between nociceptive and neuropathic pain. Therefore, pain relief can be thoroughly evaluated. [ABSTRACT FROM AUTHOR]

Background: Mental health problems are common and are associated with increased disability and health care costs. Problem-Solving Treatment (PST) delivered to these patients by nurses in primary care might be efficient. The aim of this study was to evaluate the cost-effectiveness of PST by mental health nurses compared with usual care (UC) by the general practitioner for primary care patients with mental health problems. Methods: An economic evaluation from a societal perspective was performed alongside a randomized clinical trial. Patients with a positive General Health Questionnaire score (score ≥ 4) and who visited their general practitioner at least three times during the past 6 months were eligible. Outcome measures were improvement on the Hospital Anxiety and Depression Scale and QALYs based on the EQ-5D. Resource use was measured using a validated questionnaire. Missing cost and effect data were imputed using multiple imputation techniques. Bootstrapping was used to analyze costs and cost-effectiveness of PST compared with UC. Results: There were no statistically significant differences in clinical outcomes at 9 months. Mean total costs were €4795 in the PST group and €6857 in the UC group. Costs were not statistically significantly different between the two groups (95% CI -4698;359). The cost-effectiveness analysis showed that PST was cost-effective in comparison with UC. Sensitivity analyses confirmed these findings. Conclusions: PST delivered by nurses seems cost-effective in comparison with UC. However, these results should be interpreted with caution, since the difference in total costs was mainly caused by 3 outliers with extremely high indirect costs in the UC group. Trial registration: Nederlands Trial Register ISRCTN51021015 [ABSTRACT FROM AUTHOR]