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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]

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: Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care.Methods: In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P.Discussion: We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care.Trial Registration: Dutch Trial Registry, identifier: NTR4686 , Registered on 14 July 2014. [ABSTRACT FROM AUTHOR]

Purpose: Despite a call for earlier diagnosis of dementia, the diagnostic yield of case finding and its impact on the mental health of patients and relatives are unclear. This study assessed the effect of a two-component intervention of case finding and subsequent care on these outcomes. Methods: In a cluster RCT we assessed whether education of family physicians (FPs; trial stage 1) resulted in more mild cognitive impairment (MCI) and dementia diagnoses among older persons in whom FPs suspected cognitive decline and whether case finding by a practice nurse and the FP (trial stage 2) added to this number of diagnoses. In addition, we assessed mental health effects of case finding and subsequent care (trial stage 2). FPs of 15 primary care practices (PCPs = clusters) judged the cognitive status of all persons ≥ 65 years. The primary outcome, new MCI and dementia diagnoses by FPs after 12 months as indicated on a list, was assessed among all persons in whom FPs suspected cognitive impairment but without a formal diagnosis of dementia. The secondary outcome, mental health of patients and their relatives, was assessed among persons consenting to participate in trial stage 2. Trial stage 1 consisted of either intervention component 1: training FPs to diagnose MCI and dementia, or control: no training. Trial stage 2 consisted of either intervention component 2: case finding of MCI and dementia and care by a trained nurse and the FP, or control: care as usual. Results: Seven PCPs were randomized to the intervention; eight to the control condition. MCI or dementia was diagnosed in 42.3% (138/326) of persons in the intervention, and in 30.5% (98/321) in the control group (estimated difference GEE: 10.8%, OR: 1.51, 95%-CI 0.60–3.76). Among patients and relatives who consented to stage 2 of the trial (n = 145; 25%), there were no differences in mental health between the intervention and control group. Conclusions: We found a non-significant increase in the number of new MCI diagnoses. As we cannot exclude a clinically relevant effect, a larger study is warranted to replicate ours. Trial Registration: Nederlands Trial Register [ABSTRACT FROM AUTHOR]

Background: Studies evaluating collaborative care for anxiety disorders are recently emerging. A systematic review and meta-analysis to estimate the effect of collaborative care for adult patients with anxiety disorders in primary care is therefore warranted. Methods: A literature search was performed. Data sources: PubMed, Psycinfo, Embase, Cinahl, and the Cochrane library. Study eligibility criteria: Randomized controlled trials examining the effects of collaborative care for adult primary care patients with an anxiety disorder, compared to care as usual or another intervention. Synthesis methods: Standardized mean differences (SMD) on an anxiety scale closest to twelve months follow-up were calculated and pooled in a random effects meta-analysis. Results: Of the 3073 studies found, seven studies were included with a total of 2105 participants. Included studies were of moderate to high quality. Collaborative care was superior to care as usual, with a small effect size (SMD = 0.35 95 % CI 0.14-0.56) for all anxiety disorders combined and a moderate effect size (SMD = 0.59, 95 % CI 0.41-0.78) in a subgroup analysis (five studies) on patients with panic disorder. Conclusions: Collaborative care seems to be a promising strategy for improving primary care for anxiety disorders, in particular panic disorder. However, the number of studies is still small and further research is needed to evaluate the effectiveness in other anxiety disorders. [ABSTRACT FROM AUTHOR]

Background: Dementia is often not formally diagnosed in primary care. To what extent this is due to family physicians' (FPs) watchful waiting, reluctance to diagnose or to their unawareness of the presence of cognitive impairment is unclear. The objective of this study was to assess FPs' awareness of cognitive impairment by comparing their evaluation of the absence or presence of cognitive impairment in older patients without an established diagnosis of dementia, with a reference test of cognitive functioning. In addition, we assessed which patient characteristics were associated with con- and discordance between FPs' evaluation of cognition and results of the reference test. Methods: The design was a nested diagnostic study. FPs (n = 29) of 15 primary care practices classified the cognitive status of all their patients = 65 years of age (n = 7865) into four categories, based on recollection and medical records. All patients categorized as 'possible cognitive impairment or dementia' and a sample of patients categorized as 'no signs of cognitive impairment' randomly selected to match age and gender were offered to receive a reference test of cognitive function (the CAMCOG) to verify the FPs' label. This reference test could yield three outcomes: no cognitive impairment, amnestic mild cognitive impairment (aMCI) or dementia. Reference test results were weighted back to the original samples to provide estimates for the correct categorization of elderly as 'possible cognitive impairment or dementia' (positive predictive value [PPV]) and 'no signs of cognitive impairment' (negative predictive value [NPV]). Cognitive functioning was not assessed for patients evaluated by FPs as 'probable dementia' and 'unknown or no recent contact'. Characteristics associated with the con- or discordance of the FPs' classification and the reference test were assessed using logistic regression. Results: Complete reference test results were obtained from 318 elderly. FPs labeled 8.3% of elderly 'possible cognitive impairment or dementia'. The PPV of this label for a CAMCOG score suggestive of dementia or aMCI was 47.1% (95%-confidence interval: 43.5 - 62.4%). FPs labeled 83.7% 'no signs of cognitive impairment'. The 1-NPV of this label for a CAMCOG score suggestive of dementia or aMCI was 12.5% (95%-CI 8.2 - 16.8%). FPs labeled 3.6% as 'probable dementia' and 4.5% as 'unknown or no recent contact'. The odds that FPs' suspicion of cognitive impairment were confirmed by the CAMCOG were higher if persons were ADL dependent (OR 2.24 [95%-CI 1.16 - 4.35]). The odds of FPs being unaware of the presence of cognitive impairment were higher in the older elderly (OR 1.15 [95%-CI 1.09 - 1.23] per year). Conclusion: Evaluation of FPs' classification of the global cognitive function of elderly without a firm diagnosis of dementia showed both over- and unawareness of the presence of cognitive impairment. FPs were more often unaware of cognitive impairment in the older elderly. [ABSTRACT FROM AUTHOR]

Background: To determine if major depressive disorder (MDD) in older primary care patients is an independent risk factor for cardiovascular events. Methods: A cohort of 143 primary care patients with depression and 139 non-depressed controls without depression (both aged over 55 years, matched for age and gender) from the Netherlands was evaluated for 2 years. MDD was diagnosed according to DSM-IV--criteria. During the follow-up period, information was collected on physical health, depression status and behavioural risk factors. CVD end points were assessed with validated annual questionnaires and were crosschecked with medical records. Results: Thirty-four participants experienced a cardiovascular event, of which 71 % were depressed: 27/134 with MDD (20.1 %) and 9/137 controls (6.6 %). MDD was associated with a hazard ratio of 2.83 (p value 0,004, 95 % CI 1.32 to 6.05) for cardiovascular events. After adjustment for cardiovascular medication, the hazard ratio was 2.46 (95 % CI 1.14 to 5.30). Conclusions: In a 2-year follow-up period, baseline MDD increased the risk for CVD in older primary care patients compared with controls, over and above well-known cardiovascular risk factors. [ABSTRACT FROM AUTHOR]

Background Anxiety scales may help primary care physicians to detect specific anxiety disorders among the many emotionally distressed patients presenting in primary care. The anxiety scale of the Four-Dimensional Symptom Questionnaire (4DSQ) consists of an admixture of symptoms of specific anxiety disorders. The research questions were: (1) Is the anxiety scale unidimensional or multidimensional? (2) To what extent does the anxiety scale detect specific DSM-IV anxiety disorders? (3) Which cut-off points are suitable to rule out or to rule in (which) anxiety disorders? Methods We analyzed 5 primary care datasets with standardized psychiatric diagnoses and 4DSQ scores. Unidimensionality was assessed through confirmatory factor analysis (CFA). We examined mean scores and anxiety score distributions per disorder. Receiver operating characteristic (ROC) analysis was used to determine optimal cut-off points. Results Total n was 969. CFA supported unidimensionality. The anxiety scale performed slightly better in detecting patients with panic disorder, agoraphobia, social phobia, obsessive compulsive disorder (OCD) and post traumatic stress disorder (PTSD) than patients with generalized anxiety disorder (GAD) and specific phobia. ROC-analysis suggested that ≥4 was the optimal cut-off point to rule out and ≥10 the cut-off point to rule in anxiety disorders. Conclusions The 4DSQ anxiety scale measures a common trait of pathological anxiety that is characteristic of anxiety disorders, in particular panic disorder, agoraphobia, social phobia, OCD and PTSD. The anxiety score detects the latter anxiety disorders to a slightly greater extent than GAD and specific phobia, without being able to distinguish between the different anxiety disorder types. The cut-off points ≥4 and ≥10 can be used to separate distressed patients in three groups with a relatively low, moderate and high probability of having one or more anxiety disorders. [ABSTRACT FROM AUTHOR]

Background: Questionnaires may help in detecting and diagnosing anxiety disorders in primary care. However, since utility of these questionnaires in target populations is rarely studied, the Patient Health Questionnaire anxiety modules (PHQ) were evaluated for use as: a) a screener in high-risk patients, and/or b) a case finder for general practitioners (GPs) to assist in diagnosing anxiety disorders. Methods: A cross-sectional analysis was performed in 43 primary care practices in the Netherlands. The added value of the PHQ was assessed in two samples: 1) 170 patients at risk of anxiety disorders (or developing them) according to their electronic medical records (high-risk sample); 2) 141 patients identified as a possible 'anxiety case' by a GP (GP-identified sample). All patients completed the PHQ and were interviewed using the Mini International Neuropsychiatric interview to classify DSM-IV anxiety disorders. Psychometric properties were calculated, and a logistic regression analysis was performed to assess the diagnostic value of the PHQ. Results: Using only the screening questions of the PHQ, the area under the curve was 83% in the high-risk sample. In GP-identified patients the official algorithm showed the best characteristics with an area under the curve of 77%. Positive screening questions significantly increased the odds of an anxiety disorder diagnosis in high-risk patients (odds ratio = 23.4; 95% confidence interval 6.9 to 78.8) as did a positive algorithm in GP-identified patients (odds ratio = 13.9; 95% confidence interval 3.8 to 50.6). Conclusions: The PHQ screening questions can be used to screen for anxiety disorders in high-risk primary care patients. In GP-identified patients, the benefit of the PHQ is less evident. [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: 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. Methods/design: 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. Discussion: 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. [ABSTRACT FROM AUTHOR]

Background: Little is known about the course and outcome of untreated anxiety and depression in patients with and without a self-perceived need for care. The aim of the present study was to examine the one-year course of untreated anxiety and depression, and to determine predictors of a poor outcome. Method: Baseline and one-year follow-up data were used of 594 primary care patients with current anxiety or depressive disorders at baseline (established by the Composite Interview Diagnostic Instrument (CIDI)), from the Netherlands Study of Depression and Anxiety (NESDA). Receipt of and need for care were assessed by the Perceived Need for Care Questionnaire (PNCQ). Results: In depression, treated and untreated patients with a perceived treatment need showed more rapid symptom decline but greater symptom severity at follow-up than untreated patients without a self-perceived mental problem or treatment need. A lower education level, lower income, unemployment, loneliness, less social support, perceived need for care, number of somatic disorders, a comorbid anxiety and depressive disorder and symptom severity at baseline predicted a poorer outcome in both anxiety and depression. When all variables were considered at the same time, only baseline symptom severity appeared to predict a poorer outcome in anxiety. In depression, a poorer outcome was also predicted by more loneliness and a comorbid anxiety and depressive disorder. Conclusion: In clinical practice, special attention should be paid to exploring the need for care among possible risk groups (e.g. low social economic status, low social support), and support them in making an informed decision on whether or not to seek treatment. [ABSTRACT FROM AUTHOR]

The primary care evaluation of mental disorders (PRIME-MD) can be seen as characteristic for successive refinements of criteria and structured interview techniques for diagnosing psychiatric disorders in primary care. It is one of the most widely used instruments, but there is no evidence to support its test-retest reliability. With 1-week intervals between interviews, a test-retest study of the PRIME-MD was conducted in a general practice population of 100 distressed patients (20- to 60-years old) who were on sick leave. Almost everyone (89%) received one or more diagnoses at both measurements, and there was fair total agreement (k=0.27). The best agreement was found for more severe threshold disorders [major depressive disorder (k=0.58), dysthymia (k=0.57), and generalized anxiety disorder (k = 0.59)], while we found indefinite results for the sub-threshold disorders [anxiety disorder not otherwise specified (NOS) (k=.30), minor depressive disorder (k=-0.03), and somatoform disorder NOS (k=0.11)]. The PRIME-MD is one of the few instruments in primary care that actually diagnoses specific mental disorders according to the DSM criteria. However, there was a failure to adequately classify sub-threshold disorders. Mental disorders, as seen in primary care, encompass important specific symptoms and clinical syndromes that vary in duration and severity over time, but they also encompass an admixture of somatic and psychological symptoms that do not match current diagnostic systems. This most likely resulted in methodological uncertainty about the level of agreement. Diagnostic criteria in psychiatry need to be operationalized for use in primary care and require further evaluation. [ABSTRACT FROM AUTHOR]

Background Late-life depression is associated with chronic illness, disability, and a poor prognosis. Primary care management may be in need of improvement. Aim To compare the effects of an intervention programme that aims to improve the identification, diagnosis, and treatment of depression in patients aged ≥55 years with the effects of usual care. Design of study Cluster randomised controlled trial. Setting General practices in the Netherlands. Method Trained GPs performed the intervention and their practice assistants conducted the screenings. Patients were screened with the 15-item Geriatric Depression Scale (GDS-15) and given a consultation with the GP who diagnosed depression with the mood module of the Primary Care Evaluation of Mental Disorders (PRIME-MD). Antidepressant treatment was proposed. Primary outcomes were measured with the Montgomery Åsberg Depression Rating Scale (MÅDRS). Trained independent research assistants performed independent evaluations in both arms. Results Eighteen practices (23 GPs) were allocated to the intervention and 16 practices (20 GPs) to usual care. From June 2000 to September 2002, 3937 patients were screened; 579 patients had a positive Score on the GDS-15, 178 had major depression, of whom 145 participated in the trial. MÅDRS scores for the intervention group dropped from 21.66 at baseline to 9.23 at 6 months, and the usual care group from 20.94 at baseline to 11.45 at 6 months. MÅDRS scores decreased during the year in both arms. For the intervention group, these scores increased between 6 and 12 months. Conclusion The programme resulted in lower MÅDRS scores in the intervention group than in the usual care group, but only at the end of the intervention, at 6 months after baseline. [ABSTRACT FROM AUTHOR]

Introduction: Stepped care strategies are potentially effective to organise integrated care but unknown is whether they function well in practice. This paper evaluates the implementation of a stepped care programme for depression in primary care and secondary care. Theory and methods: We developed a stepped care algorithm for diagnostics and treatment of depression, supported by a liaison-consultation function. In a 21/2 year study with pre-post design in a pilot region, adherence to the protocol was assessed by interviewing 28 caregivers of 235 patients with mild, moderate, or severe major depression. Consultation and referral patterns between primary and secondary care were analysed. Results: Adherence of general practitioners and consultant caregivers to the stepped care protocol proved to be 96%. The percentage of patients referred for depression to secondary care decreased significantly from 26% to 21% (p=0.0180). In the post-period more patients received treatment in primary care and requests for consultation became more concordant with the stepped care protocol. Conclusions: Implementation of a stepped care programme is feasible in a primary and secondary care setting and is associated with less referrals. Discussion: Further research on all subsequent treatment steps in a standardised stepped care protocol is needed. [ABSTRACT FROM AUTHOR]

Objective: Mental health problems often affect functioning to such an extent that they result in sick leave. The worldwide reported prevalence of mental health problems in the working population is 10%-18%. In developed countries, mental health problems are one of the main grounds for receiving disability benefits. In up to 90% of cases the cause is stress-related, and health-care utilisation is mainly restricted to primary care. The aim of this study was to assess the effectiveness of our Minimal Intervention for Stress-related mental disorders with Sick leave (MISS) in primary care, which is intended to reduce sick leave and prevent chronicity of symptoms. Design: Cluster-randomised controlled educational trial. Setting: Primary health-care practices in the Amsterdam area, The Netherlands. Participants: A total of 433 patients (MISS n 1/4 227, usual care [UC] n 1/4 206) with sick leave and self-reported elevated level of distress. Interventions: Forty-six primary care physicians were randomised to either receive training in the MISS or to provide UC. Eligible patients were screened by mail. Outcome Measures: The primary outcome measure was duration of sick leave until lasting full return to work. The secondary outcomes were levels of self-reported distress, depression, anxiety, and somatisation. Results: No superior effect of the MISS was found on duration of sick leave (hazard ratio 1.06, 95% confidence interval 0.87-1.29) nor on severity of self-reported symptoms. Conclusions: We found no evidence that the MISS is more effective than UC in our study sample of distressed patients. Continuing research should focus on the potential beneficial effects of the MISS; we need to investigate which elements of the intervention might be useful and which elements should be adjusted to make the MISS effective. [ABSTRACT FROM AUTHOR]

Background: Minor and mild-major depression are highly prevalent in primary care. There is insufficient evidence for the effectiveness of antidepressants the treatment of minor and mildmajor depression. We compared the effectiveness of usual primary care treatment, with or without antidepressants, in minor and mild-major depression. Methods: A pragmatic patient-randomized equivalence trial with 52 weeks follow-up was conducted in The Netherlands. In total, 59 primary care physicians (PCPs) recruited and treated 181 adult patients with minor or mild-major depression. Patients were randomized to four consultations within 3 months of usual care plus antidepressants (UCandAD) or usual care alone (UCnoAD). The Montgomery Åsberg Depression Rating Scale (MADRS) was used to assess changes in severity of depressive symptoms. The predefined equivalence margin was set at five points. Multilevel analysis was used to analyze the data. Secondary outcome measures were the Short-Form 36 (SF-36), and the Client Satisfaction Questionnaire (CSQ-8). Results: Patients received on average 3.0 (SD 1.4) 15-min consultations within 3 months with (n = 85) or without paroxetine (n = 96). Equivalence of UCandAD and UCnoAD was demonstrated in the intention-to-treat analyses as well as the per-protocol analysis after 6 weeks, but not at 13, 26 and 52 weeks follow-up. No statistical differences in effectiveness between treatment groups were found in the intention-to-treat analysis. No differences in the physical and mental functioning (SF-36) were found between the treatment groups. Patients allocated to UCandAD were slightly more satisfied with their treatment at 13 weeks follow-up (but not at 52 weeks follow-up) than patients allocated to UCnoAD. Preliminary analyses suggested that subgroups such as patients with mild-major (instead of a minor) depression might benefit from antidepressant treatment. Patients Conclusion: UCandAD was as effective as UCnoAD over the first 6 weeks, but not at 13, 26, and 52 weeks. However, superiority of either treatment could not be demonstrated either. The question whether antidepressants add any clinical effect to usual care remains unresolved. We recommend future studies to look for subgroups of patients who may benefit from antidepressants. Trial registration: Dutch Trial Registry ISRCN03007807. [ABSTRACT FROM AUTHOR]