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Background: Selection of the optimal initial treatment in patients with major depressive disorder (MDD) in need of highly specialized care has the potential to benefit treatment outcomes and cost-effectiveness of treatment strategies. However, to date, there is a paucity of measures that could guide the selection of the initial treatment, in particular to indicate which patients with MDD are in need of highly specialized care. Recognizing this gap, this paper reports on the development and psychometric evaluation of the Decision Tool Unipolar Depression (DTUD), aimed to facilitate the early identification of patients with MDD in need of highly specialized care., Methods: The DTUD was developed using a mixed-methods approach, consisting of a systematic review and a concept mapping study. To evaluate the psychometric features of the DTUD, a cross-sectional multicenter study was conducted. A total of 243 patients with MDD were evaluated with the DTUD. Feasibility was operationalized as the time required to complete the DTUD and the content clarity of the DTUD. Inter-rater reliability was evaluated using Krippendorf's alpha. The Maudsley Staging Method (MSM) and the Dutch Measure for quantification of Treatment Resistance in Depression (DM-TRD) were administered to assess the convergent validity. A receiver operator characteristic curve was generated to evaluate the criterion validity and establish the optimal cut-off value., Results: The mean administration time was 4.49 min (SD = 2.71), and the content of the total DTUD was judged as clear in 94.7% of the evaluations. Inter-rater reliability values ranged from 0.69 to 0.91. Higher scores on the DTUD were associated with higher scores on the MSM (r s  = 0.47) and DM-TRD (r s  = 0.53). Based on the maximum Youden index (0.494), maximum discrimination was reached at a cut-off score of ≥5 (sensitivity 67%, specificity 83%)., Conclusion: The DTUD demonstrated to be a tool with solid psychometric properties and, therefore, is a promising measure for the early identification of patients with MDD in need of highly specialized care. Use of the DTUD has the potential to facilitate the selection and initiation of the optimal initial treatment in patients with MDD, which in turn may improve the clinical effectiveness and cost-effectiveness of treatment strategies.

Background: The Treatment Inventory Cost in Psychiatric patients (TIC-P) instrument is designed to measure societal costs in patients with psychiatric disorders and to be applied in economic evaluations. Efforts have been made to minimize respondents' burden by reducing the number of questions and meanwhile retaining the comprehensiveness of the instrument. Previously, a TIC-P Mini version and a TIC-P Midi version were developed and tested in a predominantly inpatient patient population., Aims of the Study: The aims of this study are to examine the comprehensiveness of the abridged questionnaires in estimating the societal costs for patients with anxiety or depressive disorders and to assess the impact of productivity costs on the total costs., Methods: The comprehensiveness of the abridged versions of the TIC-P was assessed in four populations: a group of primary care patients with anxiety disorders (n=175) and three groups of patients with major depressive disorders in various outpatient settings (n=140; n=125; and n=79). Comprehensiveness was measured using the proportion of total health care costs and productivity costs covered by the abridged versions compared to the full-length TIC-P. Costs were calculated according to the guidelines for costing studies using the Dutch costing manual., Results: Our results showed that the TIC-P Mini covered 26%-64% of health care costs and the TIC-P Midi captured 54%-79% of health care costs. Health care costs in these populations were predominantly dispersed over primary care, outpatient hospital care, outpatient specialist care and inpatient hospital care. The TIC-P Midi and TIC-P Mini captured 22% and 0% of primary care costs respectively. In contrast, inpatient hospital care costs and outpatient specialist mental health care costs were almost fully included in the abridged versions. Costs due to lost productivity as measured by the full-length TIC-P were substantial, representing 38% to 92% of total costs., Discussion: A reduction of the number of items resulted in a substantial loss in the ability to measure health care costs compared to the full-length TIC-P, because these outpatient populations consumed health care from a variety of health care providers. Two limitations of the study need to be stressed. Firstly, the number of patients in each of the four studies was relatively small. However, results were consistent over the four studies despite the small number of patients. Secondly, we did not take costs of medication into account., Implications for Health Policies: In developing mental health policy, it is important to include considerations on cost-effectiveness. Increasing the evidence on instruments to measure costs from a societal perspective may support policymakers to adopt a broader perspective., Implications for Further Research: The TIC-P Mini is not suitable to capture health care costs in outpatients with anxiety or depressive disorders. The comprehensiveness of TIC-P Midi compared to the full-length TIC-P varied. The TIC-P Midi should therefore be revised in order to better capture costs in all patient groups.

Objectives: Early identification of patients with major depressive disorder (MDD) that cannot be managed by secondary mental health services and who require highly specialized mental healthcare could enhance need-based patient stratification. This, in turn, may reduce the number of treatment steps needed to achieve and sustain an adequate treatment response. The development of a valid tool to identify patients with MDD in need of highly specialized care is hampered by the lack of a comprehensive understanding of indicators that distinguish patients with and without a need for highly specialized MDD care. The aim of this study, therefore, was to systematically review studies on indicators of patients with MDD likely in need of highly specialized care., Methods: A structured literature search was performed on the PubMed and PsycINFO databases following PRISMA guidelines. Two reviewers independently assessed study eligibility and determined the quality of the identified studies. Three reviewers independently executed data extraction by using a pre-piloted, standardized extraction form. The resulting indicators were grouped by topical similarity, creating a concise summary of the findings., Results: The systematic search of all databases yielded a total of 7,360 references, of which sixteen were eligible for inclusion. The sixteen papers yielded a total of 48 unique indicators. Overall, a more pronounced depression severity, a younger age of onset, a history of prior poor treatment response, psychiatric comorbidity, somatic comorbidity, childhood trauma, psychosocial impairment, older age, and a socioeconomically disadvantaged status were found to be associated with proxies of need for highly specialized MDD care., Conclusions: Several indicators are associated with the need for highly specialized MDD care. These indicators provide easily measurable factors that may serve as a starting point for the development of a valid tool to identify patients with MDD in need of highly specialized care., Competing Interests: The authors have declared that no competing interests exist.

Objective: Major depression is a great burden on society, as it is associated with high disability/costs. The aim of this study was to evaluate the cost-utility of Collaborative Care (CC) for major depressive disorder compared to Care As Usual (CAU) in a primary health care setting from a societal perspective., Methods: A cluster randomized controlled trial was conducted, including 93 patients that were identified by screening (45-CC, 48-CAU). Another 57 patients were identified by the GP (56-CC, 1-CAU). The outcome measures were TiC-P, SF-HQL and EQ-5D, respectively measuring health care utilization, production losses and general health related quality of life at baseline three, six, nine and twelve months. A cost-utility analysis was performed for patients included by screening and a sensitivity analysis was done by also including patients identified by the GP., Results: The average annual total costs was €1131 (95% C.I., €-3158 to €750) lower for CC compared to CAU. The average quality of life years (QALYs) gained was 0.02 (95% C.I., -0.004 to 0.04) higher for CC, so CC was dominant from a societal perspective. Taking a health care perspective, CC was less cost-effective due to higher costs, €1173 (95% C.I., €-216 to €2726), of CC compared to CAU which led to an ICER of 53,717 Euro/QALY. The sensitivity analysis showed dominance of CC., Conclusion: The cost-utility analysis from a societal perspective showed that CC was dominant to CAU. CC may be a promising treatment for depression in the primary care setting. Further research should explore the cost-effectiveness of long-term CC., Trial Registration: Netherlands Trial Register ISRCTN15266438., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: Major depression is associated with high levels of absence and reduced productivity. Therefore the costs to society are high. The aim of this study was to evaluate the cost-utility of collaborative care for major depressive disorder (MDD) compared to care as usual in an occupational healthcare setting. A societal perspective was taken., Methods: In this randomised controlled trial, 126 sick-listed workers with MDD were included (65 collaborative care, 61 care as usual). Baseline measurements and follow up measures (3, 6, 9 and 12 months) were assessed by questionnaire. We applied the Trimbos/iMTA questionnaire for costs associated with psychiatric illness, the SF-HQL and the EQ-5D respectively measuring the health care utilization, production losses and general health related quality of life., Results: The average annual healthcare costs in the collaborative care group were €3,874 (95 % CI €2,778-€ 5,718) compared to €4,583 (95 % CI €3,108-€6,794) in the care as usual group. The average quality of life years (QALY's) gained were lower in the collaborative care group, 0.05 QALY. The majority of the ICERS (69 %) indicate that collaborative care is less costly but also less effective than care as usual. Including the productivity costs did not change this result., Conclusions: The cost-utility analysis showed that collaborative care generated reduced costs and a reduction in effects compared to care as usual and was therefore not a cost-effective intervention.

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., 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., 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., Trial Registration: NTR1089.

Background: Practice variation in the primary care treatment of depression may be considerable in the Netherlands, due to relatively small and unregulated practices. We adapted the collaborative care model for the treatment of Major Depressive Disorder (MDD) to accommodate existing practice variation and tested whether this had added value over Care as Usual (CAU)., Methods: A cluster randomized controlled trial was conducted to compare an adapted target driven collaborative care model with Care as Usual (CAU). Randomization was at the level of 18 (sub)urban primary care centers. The care manager and GP were supported by a web-based tracking and decision aid system that advised targeted treatment actions to achieve rapid response and if possible remission, and that warned the consultant psychiatrist if such treatment advice was not followed up. Eligible patients had a score of 10 or higher on the PHQ9, and met diagnostic criteria for major depression at the subsequent MINI Neuropsychiatric interview. A total of 93 patients were identified by screening. They received either collaborative care (CC) or CAU. Another 56 patients received collaborative care after identification by the GP. The outcome measures were response to treatment (50% or greater reduction of the PHQ9-total score from baseline) at three, six, nine and twelve months, and remission (a score of 0-4 on the PHQ9 at follow-up)., Results: Treatment response and remission in CAU were low. Collaborative care was more effective on achieving treatment response than CAU at three months for the total group of patients who received collaborative care [OR 5.2 ((1.41-16.09), NNT 2] and at nine months [OR 5.6 ((1.40-22.58)), NNT 3]. The effect was not statistically significant at 6 and 12 months., Limitations: A relatively high percentage of patients (36.5%) did not return one or more follow-up questionnaires. There was no evidence for selective non response., Conclusions: Our adapted target driven CC was considerably more effective than CAU for MDD in primary care in the Netherlands. The Numbers Needed To Treat (NNT) to achieve response in one additional patient were low (2-3), which suggest that introducing CC at a larger scale may be beneficial. The relatively large effects may be due to our focus on reducing practice variation through the introduction of easy to use web based tracking and decision aids. The findings are highly relevant for the application of the model in areas where practices tend to be small and for mixed healthcare systems such as in many countries in Europe., Trial Registration: Dutch trial register ISRCTN15266438 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=820)., (Copyright © 2012 Elsevier B.V. All rights reserved.)

Background: For the treatment of depression in diabetes patients, it is important that depression is recognized at an early stage. A screening method for depression is the patient health questionnaire (PHQ-9). The aim of this study is to validate the 9-item Patient Health Questionnaire (PHQ-9) as a screening instrument for depression in diabetes patients in outpatient clinics., Methods: 197 diabetes patients from outpatient clinics in the Netherlands filled in the PHQ-9. Within 2 weeks they were approached for an interview with the Mini Neuropsychiatric Interview. DSM-IV diagnoses of Major Depressive Disorder (MDD) were the criterion for which the sensitivity, specificity, positive- and negative predictive values and Receiver Operator Curves (ROC) for the PHQ-9 were calculated., Results: The cut-off point of a summed score of 12 on the PHQ-9 resulted in a sensitivity of 75.7% and a specificity of 80.0%. Predictive values for negative and positive test results were respectively 93.4% and 46.7%. The ROC showed an area under the curve of 0.77., Conclusions: The PHQ-9 proved to be an efficient and well-received screening instrument for MDD in this sample of diabetes patients in a specialized outpatient clinic. The higher cut-off point of 12 that was needed and somewhat lower sensitivity than had been reported elsewhere may be due to the fact that the patients from a specialized diabetes clinic have more severe pathology and more complications, which could be recognized by the PHQ-9 as depression symptoms, while instead being diabetes symptoms.

Background: The effectiveness of collaborative care for patients with major depressive disorder in primary care has been established. Assessing its cost-effectiveness is important for deciding on implementation. This review therefore evaluates the cost-effectiveness of collaborative care for major depressive disorder in primary care., Methods: A systematic search on economic evaluations of collaborative care was conducted in Pubmed and PsychInfo. Quality of the studies was measured with the Cochrane checklist and the CHEC-list for economic evaluations. Cost-effectiveness and costs per depression-free days were reported., Results: 8 studies were found, involving 4868 patients. The quality of the cost effectiveness studies, according to the CHEC-list, could be improved. Generally, the studies did not include all relevant costs and did not perform sensitivity analysis. Only 4 out of 8 studies reported cost per QALY, 6 out of 8 reported costs per depression-free days. The highest costs per QALY reported were $49,500, the highest costs per depression-free day were $24., Conclusions: Although studies did not fulfil all criteria of the CHEC-list, collaborative care is a promising intervention and it may be cost-effective. However, to conclude on the cost-effectiveness, depression research should follow economic guidelines to improve the quality of the economic evaluations.

Background: Major depressive disorder (MDD) has major consequences for both patients and society, particularly in terms of needlessly long sick leave and reduced functioning. Although evidence-based treatments for MDD are available, they show disappointing results when implemented in daily practice. A focus on work is also lacking in the treatment of depressive disorder as well as communication of general practitioners (GPs) and other health care professionals with occupational physicians (OPs). The OP may play a more important role in the recovery of patients with MDD. Purpose of the present study is to tackle these obstacles by applying a collaborative care model, which has proven to be effective in the USA, with a focus on return to work (RTW). From a societal perspective, the (cost)effectiveness of this collaborative care treatment, as a way of transmural care, will be evaluated in depressed patients on sick leave in the occupational health setting., Methods/design: A randomised controlled trial in which the treatment of MDD in the occupational health setting will be evaluated in the Netherlands. A transmural collaborative care model, including Problem Solving Treatment (PST), a workplace intervention, antidepressant medication and manual guided self-help will be compared with care as usual (CAU). 126 Patients with MDD on sick leave between 4 and 12 weeks will be included in the study. Care in the intervention group will be provided by a multidisciplinary team of a trained OP-care manager and a consultant psychiatrist. The treatment is separated from the sickness certification. Data will be collected by means of questionnaires at baseline and at 3, 6, 9 and 12 months after baseline. Primary outcome measure is reduction of depressive symptoms, secondary outcome measure is time to RTW, tertiary outcome measure is the cost effectiveness., Discussion: The high burden of MDD and the high level of sickness absence among people with MDD contribute to the relevance of this study. The intervention is an innovative approach, with trained OPs in a new role as care managers in the treatment of MDD. If this intervention proves to be cost-effective, implementation will be very relevant for individual patients as well as for society., Trial Registration: ISRCTN78462860.

Background: Depressive disorder is currently one of the most burdensome disorders worldwide. Evidence-based treatments for depressive disorder are already available, but these are used insufficiently, and with less positive results than possible. Earlier research in the USA has shown good results in the treatment of depressive disorder based on a collaborative care approach with Problem Solving Treatment and an antidepressant treatment algorithm, and research in the UK has also shown good results with Problem Solving Treatment. These treatment strategies may also work very well in the Netherlands too, even though health care systems differ between countries., Methods/design: This study is a two-armed randomised clinical trial, with randomization on patient-level. The aim of the trial is to evaluate the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework, including contracting and adherence-improving strategies, combined with Problem Solving Treatment and antidepressant medication according to a treatment algorithm. Forty general practices will be randomised to either the intervention group or the control group. Included will be patients who are diagnosed with moderate to severe depression, based on DSM-IV criteria, and stratified according to comorbid chronic physical illness. Patients in the intervention group will receive treatment based on the collaborative care approach, and patients in the control group will receive care as usual. Baseline measurements and follow up measures (3, 6, 9 and 12 months) are assessed using questionnaires and an interview. The primary outcome measure is severity of depressive symptoms, according to the PHQ9. Secondary outcome measures are remission as measured with the PHQ9 and the IDS-SR, and cost-effectiveness measured with the TiC-P, the EQ-5D and the SF-36., Discussion: In this study, an American model to enhance care for patients with a depressive disorder, the collaborative care model, will be evaluated for effectiveness in the primary care setting. If effective across the Atlantic and across different health care systems, it is also likely to be an effective strategy to implement in the treatment of major depressive disorder in the Netherlands.

Background: Depressive disorder is one of the most common disorders, and is highly prevalent in chronically ill patients. The presence of comorbid depression has a negative influence on quality of life, health care costs, self-care, morbidity, and mortality. Early diagnosis and well-organized treatment of depression has a positive influence on these aspects. Earlier research in the USA has reported good results with regard to the treatment of depression with a collaborative care approach and an antidepressant algorithm. In the UK 'Problem Solving Treatment' has proved to be feasible. However, in the general hospital setting this approach has not yet been evaluated., Methods/design: CC: DIM (Collaborative Care: Depression Initiative in the Medical setting) is a two-armed randomised controlled trial with randomisation at patient level. The aim of the trial is to evaluate the treatment of depressive disorder in general hospitals in the Netherlands based on a collaborative care framework, including contracting, 'Problem Solving Treatment', antidepressant algorithm, and manual-guided self-help. 126 outpatients with diabetes mellitus, chronic obstructive pulmonary disease, or cardiovascular diseases will be randomised to either the intervention group or the control group. Patients will be included if they have been diagnosed with moderate to severe depression, based on the DSM-IV criteria in a two-step screening method. The intervention group will receive treatment based on the collaborative care approach; the control group will receive 'care as usual'. Baseline and follow-up measurements (after 3, 6, 9, and 12 months) will be performed by means of questionnaires. The primary outcome measure is severity of depressive symptoms, as measured with the PHQ-9. The secondary outcome measure is the cost-effectiveness of these treatments according to the TiC-P, the EuroQol and the SF-36., Discussion: Earlier research has indicated that depressive disorder is a chronic, mostly recurrent illness, which tends to cluster with physical comorbidity. Even though the treatment of depressive disorder based on the guidelines for depression is proven effective, these guidelines are often insufficiently adhered to. Collaborative care and 'Problem Solving Treatment' will be specifically tailored to patients with depressive disorders and evaluated in a general hospital setting in the Netherlands.