Search

Objective: To assess the cost-effectiveness of a brief cognitive behavioural intervention for patients with medically unexplained physical symptoms (MUPS) provided by a mental health nurse practitioner (MHNP) in primary care in comparison with usual care., Methods: We performed an economic evaluation from a societal perspective alongside a cluster randomised controlled trial with 12 months follow-up. The primary outcome was quality-adjusted life-years (QALYs). Secondary outcomes were the RAND-36 physical component summary score (PCS), somatic symptom severity (Patient Health Questionnaire (PHQ-15), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS)). Missing data were imputed using multiple imputation. We used non-parametric bootstrapping to estimate statistical uncertainty. The bootstrapped cost-effect pairs were used to estimate cost-effectiveness planes and cost-effectiveness acceptability curves., Results: Mean total costs in the intervention group were significantly lower than in the usual care group (mean difference - 2300€, 95% CI -3257 to -134). The mean difference in QALYs was 0.01 (95% CI -0.01 to 0.04), in PCS 2.46 (95% CI 1.44 to 3.47), in PHQ-15 -0.26 (95% CI -0.81 to 0.28), and in HADS -0.07 (-0.81 to 0.67). At a willingness to pay of 0 € per additional unit of effect, the probability of the intervention being cost-effective was 0.93 for QALYs and 0.92 for PCS, PHQ-15 and HADS scores., Conclusion: Our intervention is cost-effective compared to usual care for patients with MUPS. Implementation of the intervention has the potential to result in a significant decline in costs. However, large scale implementation would require increased deployment of MHNPs., Competing Interests: Declaration of Competing Interest The authors have no competing interests to report., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To examine the effectiveness of a cognitive behavioural intervention delivered by mental health nurse practitioners (MHNPs) to patients with undifferentiated somatoform disorder (USD), compared to usual care., Methods: We conducted a cluster randomized trial among primary care patients with USD comparing the intervention to usual care. The intervention consisted of six sessions with the MHNP. Primary outcome was physical functioning (RAND-36 physical component summary score). Secondary outcomes were the RAND-36 mental component summary score and the eight subscales; anxiety and depression (Hospital Anxiety and Depression Scale) and somatic symptom severity (Patient Health Questionnaire-15). Outcomes were assessed at baseline, 2, 4 and 12 months. We analysed data using linear mixed models by intention-to-treat, and investigated effect modifiers., Results: Compared to usual care (n = 87), the intervention group (n = 111) showed an improvement in physical functioning (mean difference 2.24 [95% CI 0.51; 3.97]; p = .011), a decrease in limitations due to physical problems (mean difference 10.82 [95% CI 2.14; 19.49]; p. = 0.015) and in pain (mean difference 5.08 [95% CI 0.58; 9.57]; p = .027), over 12 months. However effect sizes were small and less clinically relevant than expected. We found no differences for anxiety, depression and somatic symptom severity. Effects were larger and clinically relevant for patients with more recent symptoms and fewer physical diseases., Conclusion: The cognitive behavioural intervention was effective in improving pain and physical functioning components of patients' health. It was particularly suitable for patients with symptoms that had been present for a limited number of years and with few comorbid physical diseases., Trial Registration: The trial is registered in the Dutch Trial Registry, www.trialregister.nl, under NTR4686., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Introduction: Major depressive disorders (MDD), diabetes mellitus type 2 (DM2) and coronary heart disease (CHD) are leading contributors to the global burden of disease and often co-occur., Objectives: To evaluate the 2-year effectiveness of a stepped-care intervention to prevent MDD compared with usual care and to develop a prediction model for incident depression in patients with DM2 and/or CHD with subthreshold depression., Methods: Data of 236 Dutch primary care patients with DM2/CHD with subthreshold depression (Patient Health Questionnaire 9 (PHQ-9) score ≥6, no current MDD according to the Mini International Neuropsychiatric Interview (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria)) who participated in the Step-Dep trial were used. A PHQ-9 score of ≥10 at minimally one measurement during follow-up (at 3, 6, 9, 12 and 24 months) was used to determine the cumulative incidence of MDD. Potential demographic and psychological predictors were measured at baseline via web-based self-reported questionnaires and evaluated using a multivariable logistic regression model. Model performance was assessed with the Hosmer-Lemeshow test, Nagelkerke's R 2 explained variance and area under the receiver operating characteristic curve (AUC). Bootstrapping techniques were used to internally validate our model., Results: 192 patients (81%) were available at 2-year follow-up. The cumulative incidence of MDD was 97/192 (51%). There was no statistically significant overall treatment effect over 24 months of the intervention (OR 1.37; 95% CI 0.52 to 3.55). Baseline levels of anxiety, depression, the presence of >3 chronic diseases and stressful life events predicted the incidence of MDD (AUC 0.80, IQR 0.79-0.80; Nagelkerke's R 2 0.34, IQR 0.33-0.36)., Conclusion: A model with 4 factors predicted depression incidence during 2-year follow-up in patients with DM2/CHD accurately, based on the AUC. The Step-Dep intervention did not influence the incidence of MDD. Future depression prevention programmes should target patients with these 4 predictors present, and aim to reduce both anxiety and depressive symptoms., Trial Registration Number: NTR3715., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The aim of this review is to critically appraise the evidence on measurement properties of self-report questionnaires measuring somatization in adult primary care patients and to provide recommendations about which questionnaires are most useful for this purpose., Methods: We assessed the methodological quality of included studies using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. To draw overall conclusions about the quality of the questionnaires, we conducted an evidence synthesis using predefined criteria for judging the measurement properties., Results: We found 24 articles on 9 questionnaires. Studies on the Patient Health Questionnaire-15 (PHQ-15) and the Four-Dimensional Symptom Questionnaire (4DSQ) somatization subscale prevailed and covered the broadest range of measurement properties. These questionnaires had the best internal consistency, test-retest reliability, structural validity, and construct validity. The PHQ-15 also had good criterion validity, whereas the 4DSQ somatization subscale was validated in several languages. The Bodily Distress Syndrome (BDS) checklist had good internal consistency and structural validity. Some evidence was found for good construct validity and criterion validity of the Physical Symptom Checklist (PSC-51) and good construct validity of the Symptom Check-List (SCL-90-R) somatization subscale. However, these three questionnaires were only studied in a small number of primary care studies., Conclusion: Based on our findings, we recommend the use of either the PHQ-15 or 4DSQ somatization subscale for somatization in primary care. Other questionnaires, such as the BDS checklist, PSC-51 and the SCL-90-R somatization subscale show promising results but have not been studied extensively in primary care., (Copyright © 2017 Elsevier Inc. All rights reserved.)

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.

Background: Depression is common in patients with diabetes type 2 (DM2) and/or coronary heart disease (CHD), with high personal and societal burden and may even be preventable. Recently, a cluster randomized trial of stepped care to prevent depression among patients with DM2 and/or CHD and subthreshold depression in Dutch primary care (Step-Dep) versus usual care showed no effectiveness. This paper presents its process evaluation, exploring in-depth experiences from a patient and practice nurse perspective to further understand the results., Methods: A qualitative study was conducted. Using a purposive sampling strategy, data were collected through semi-structured interviews with 24 participants (15 patients and nine practice nurses). All interviews were audiotaped and transcribed verbatim. Atlas.ti 5.7.1 software was used for coding and structuring of themes. A thematic analysis of the data was performed., Results: The process evaluation showed, even through a negative trial, that Step-Dep was perceived as valuable by both patients and practice nurses; perceived effectiveness on improving depressive symptoms varied greatly, but most felt that it had been beneficial for patients' well-being. Facilitators were: increased awareness of mental health problems in chronic disease management and improved accessibility and decreased experienced stigma of receiving mental health care. The Patient Health Questionnaire 9 (PHQ-9), used to determine depression severity, functioned as a useful starting point for the conversation on mental health and patients gained more insight into their mental health by regularly filling out the PHQ-9. However, patients and practice nurses did not widely support its use for monitoring depressive symptoms or making treatment decisions. Monitoring mental health was deemed important in chronically ill patients by both patients and practice nurses and was suggested to start at the time of diagnosis of a chronic disease. Appointed barriers were that patients were primarily motivated to participate in scientific research rather than their intrinsic need to improve depressive symptoms. Additionally, various practice nurses preferred offering individually based therapy over pre-determined interventions in a protocolled sequence and somatic practice nurses expressed a lack of competence to recognise and treat mental health problems., Conclusion: This study demonstrates both the benefits and unique demands of programs such as Step-Dep. The appointed facilitators and barriers could guide the development of future studies aiming to prevent depression in similar patient groups.

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.

Background: Depression is common among type 2 diabetes mellitus (DM2)/coronary heart disease (CHD) patients and is associated with adverse health effects. A promising strategy to reduce burden of disease is to identify patients at risk for depression in order to offer indicated prevention. This study aims to assess the diagnostic accuracy of the Patient Health Questionnaire-9 (PHQ-9) to be used as a tool to identify high risk patients., Methods: In this cross-sectional study, 586 consecutive DM2/CHD patients aged >18 were recruited through 23 general practices. PHQ-9 outcomes were compared to the Mini International Neuropsychiatric Interview (MINI), which was considered the reference standard. Diagnostic accuracy was evaluated for minor and major depression, comparing both sum- and algorithm based PHQ-9 scores., Results: For minor depression, the optimal cut-off score was 8 (sensitivity 71%, specificity 71% and an AUC of 0.74). For major depression, the optimal cut-off score was 10 resulting in a sensitivity of 84%, a specificity of 82%, and an AUC of 0.88. The positive predictive value of the PHQ-9 algorithm for diagnosing minor and major depression was 25% and 33%, respectively., Limitations: Two main limitations apply. MINI Interviewers were not blinded for PHQ-9 scores and less than 10% of all invited patients could be included in the analyses. This could have resulted in biased outcomes., Conclusions: The PHQ-9 sum score performs well in identifying patients at high risk of minor and major depression. However, the PHQ-9 showed suboptimal results for diagnostic purposes. Therefore, it is recommended to combine the use of the PHQ-9 with further diagnostics to identify depression., (Copyright © 2015 Elsevier B.V. All rights reserved.)

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.)

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.

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.

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.)

Aim: To assess to what extent a high physical symptom count influences the effect of treatment for major depressive disorder (MDD), and whether or not actual comorbid medical conditions explain this relationship., Method: Secondary data-analysis on a cluster-randomized trial in primary care, comparing the effectiveness of collaborative care with care as usual (CAU). MDD was measured using the PHQ-9. The Physical Symptoms Questionnaire (PSQ) was filled out at baseline by 115 patients (77.2% of those who entered the trial). Multilevel logistic regression models were used to test whether a high physical symptom count predicted lack of response to treatment, adding interaction terms to test differential effects on collaborative care versus CAU., Results: A high physical symptom count negatively influenced the effect of both collaborative care and care as usual (no interaction). Specifically, a high physical symptom count predicted lack of response in both conditions at 3 (odds ratio=6.8), 6 (OR=4.1), and 9 months follow-up (OR=6.4). This was not explained by chronic physical illness., Conclusion: In this RCT, patients with MDD accompanied by a high physical symptom count benefited less from treatment for MDD in primary care, regardless of the type of treatment (either collaborative care or CAU). This was not explained by the presence of comorbid medical conditions. Further research is needed to improve treatment for MDD accompanied by a high physical symptom count, although collaborative care for depression is still more effective than CAU for this group of patients., Trial Registration: Dutch trial register ISRCTN15266438., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Anxiety disorders are highly prevalent in primary care and cause a substantial burden of disease. Screening on risk status, followed by preventive interventions in those at risk may prevent the onset of anxiety disorders, and thereby reduce the disease burden. The willingness to participate in screening and interventions is crucial for the scope of preventive strategies, but unknown. This feasibility study, therefore, investigated participation rates of screening and preventive services for anxiety disorders in primary care, and explored reasons to refrain from screening., Methods: In three general practices, screening was offered to individuals visiting their general practitioner (total n = 2454). To assess risk status, a 10-item questionnaire was followed by a telephone interview (including the CIDI) when scoring above a predefined threshold. Preventive services were offered to those at risk. Participation rates for screening and preventive services for anxiety disorders were assessed. Those not willing to be screened were asked for their main reason to refrain from screening., Results: Of all individuals, 17.3% participated in initial screening, and of those with a possible risk status, 56.0% continued screening. In 30.1% of those assessed, a risk status to develop an anxiety disorder was verified. Of these, 22.6% already received some form of mental health treatment and 38.7% of them agreed to participate in a preventive intervention and were referred. The most frequently mentioned reasons to refrain from screening were the emotional burden associated with elevated risk status, the assumption not to be at risk, and a lack of motivation to act upon an elevated risk status by using preventive services., Conclusions: Screening in general practice, followed by offering services to prevent anxiety disorders in those at risk did not appear to be a feasible strategy due to low participation rates. To enable the development of feasible and cost-effective preventive strategies, exploring the reasons of low participation rates, considering involving general practitioners in preventive strategies, and looking at preventive strategies in somatic health care with proven feasibility may be helpful.

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.

Background: Major Depressive Disorder is a leading cause of disability, tends to run a recurrent course and is associated with substantial economic costs due to increased healthcare utilization and productivity losses. Interventions aimed at the prevention of recurrences may reduce patients' suffering and costs. Besides antidepressants, several psychological treatments such as preventive cognitive therapy (PCT) are effective in the prevention of recurrences of depression. Yet, many patients find long-term use of antidepressants unattractive, do not want to engage in therapy sessions and in the primary care setting psychologists are often not available. Therefore, it is important to study whether PCT can be used in a nurse-led self-help format in primary care. This study sets out to test the hypothesis that usual care plus nurse-led self-help for recurrent depression in primary care is feasible, acceptable and cost-effective compared to usual care only., Design: Patients are randomly assigned to 'nurse-led self-help treatment plus usual care' (134 participants) or 'usual care' (134 participants). Randomisation is stratified according to the number of previous episodes (2 or 3 previous episodes versus 4 or more). The primary clinical outcome is the cumulative recurrence rate of depression meeting DSM-IV criteria as assessed by the Structured-Clinical-Interview-for-DSM-IV- disorders at one year after completion of the intervention. Secondary clinical outcomes are quality of life, severity of depressive symptoms, co-morbid psychopathology and self-efficacy. As putative effect-moderators, demographic characteristics, number of previous episodes, type of treatment during previous episodes, age of onset, self-efficacy and symptoms of pain and fatigue are assessed. Cumulative recurrence rate ratios are obtained under a Poisson regression model. Number-needed-to-be-treated is calculated as the inverse of the risk-difference. The economic evaluation is conducted from a societal perspective, both as a cost-effectiveness analysis (costs per depression free survival year) and as a cost-utility analysis (costs per quality adjusted life-year)., Discussion: The purpose of this paper is to outline the rationale and design of a nurse-led, cognitive therapy based self-help aimed at preventing recurrence of depression in a primary care setting. Only few studies have focused on psychological self-help interventions aimed at the prevention of recurrences in primary care patients., Trial Registration: NTR3001 (http://www.trialregister.nl).

Background: There is little evidence as to whether or not guideline concordant care in general practice results in better clinical outcomes for people with anxiety and depression. This study aims to determine possible associations between guideline concordant care and clinical outcomes in general practice patients with depression and anxiety, and identify patient and treatment characteristics associated with clinical improvement., Methods: This study forms part of the Netherlands Study of Depression and Anxiety (NESDA).Adult patients, recruited in general practice (67 GPs), were interviewed to assess DSM-IV diagnoses during baseline assessment of NESDA, and also completed questionnaires measuring symptom severity, received care, socio-demographic variables and social support both at baseline and 12 months later. The definition of guideline adherence was based on an algorithm on care received. Information on guideline adherence was obtained from GP medical records., Results: 721 patients with a current (6-month recency) anxiety or depressive disorder participated. While patients who received guideline concordant care (N=281) suffered from more severe symptoms than patients who received non-guideline concordant care (N=440), both groups showed equal improvement in their depressive or anxiety symptoms after 12 months. Patients who (still) had moderate or severe symptoms at follow-up, were more often unemployed, had smaller personal networks and more severe depressive symptoms at baseline than patients with mild symptoms at follow-up. The particular type of treatment followed made no difference to clinical outcomes., Conclusion: The added value of guideline concordant care could not be demonstrated in this study. Symptom severity, employment status, social support and comorbidity of anxiety and depression all play a role in poor clinical outcomes.

Background: Previous estimates of depression recognition in primary care are low and inconsistent. This may be due to registration artifacts and limited extraction efforts. This study investigated a) whether GPs' medical records demonstrate an accurate recognition of depression and b) which combinations of indications within the record most accurately reflect a diagnosis of depression., Methods: GPs' registrations were compared with a reference standard, the Composite International Diagnostic Interview (CIDI), according to DSM-IV criteria. Six definitions of GPs' recognition of depression were tested using diagnostic codes, medication data, referral data and free text in the medical records. The Youden-index was used to select the optimal definition of recognition. Data were derived from the Netherlands Study of Depression and Anxiety. 816 primary care patients from 33 general practitioners were included in the vicinities of Amsterdam and Leiden, The Netherlands., Results: Registration of antidepressant prescriptions was the best single indicator of GPs' recognition of CIDI depression with a recognition rate of 0.43. The best combination of indicators increased the recognition rate to 0.69. All indications except the specific diagnostic codes for 'depressive disorder' and 'depressive feelings' were included in this definition., Limitations: Potential bias due to the selection of participating GPs might have influenced our recognition rates., Conclusion: GPs are aware of mental health problems in most depressed patients, but labeling with specific diagnostic codes is weak. Researchers should consider that diagnostic coding alone is not an accurate measure of the diagnostic ability of depression and strongly underestimates the accuracy of the GP., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Background: Appropriate management of anxiety disorders in primary care requires clinical assessment and monitoring of the severity of the anxiety. This study focuses on the Beck Anxiety Inventory (BAI) as a severity indicator for anxiety in primary care patients with different anxiety disorders (social phobia, panic disorder with or without agoraphobia, agoraphobia or generalized anxiety disorder), depressive disorders or no disorder (controls)., Methods: Participants were 1601 primary care patients participating in the Netherlands Study of Depression and Anxiety (NESDA). Regression analyses were used to compare the mean BAI scores of the different diagnostic groups and to correct for age and gender., Results: Patients with any anxiety disorder had a significantly higher mean score than the controls. A significantly higher score was found for patients with panic disorder and agoraphobia compared to patients with agoraphobia only or social phobia only. BAI scores in patients with an anxiety disorder with a co-morbid anxiety disorder and in patients with an anxiety disorder with a co-morbid depressive disorder were significantly higher than BAI scores in patients with an anxiety disorder alone or patients with a depressive disorder alone. Depressed and anxious patients did not differ significantly in their mean scores., Conclusions: The results suggest that the BAI may be used as a severity indicator of anxiety in primary care patients with different anxiety disorders. However, because the instrument seems to reflect the severity of depression as well, it is not a suitable instrument to discriminate between anxiety and depression in a primary care population.

Objectives: Depressive symptoms are common among elderly primary care patients, and because they encounter considerable barriers in seeking help and they often resist referral to specialized mental health facilities, it is important to look for easily accessible interventions within the primary care setting. Bibliotherapy, which has been found to be effective among younger populations, might be an attractive option. In this study, the authors investigated the effectiveness of bibliotherapy for depressive symptomatology in very old adults., Design: Randomized controlled trial. After a 3-month period of "watchful waiting," the participants were randomly assigned to a bibliotherapy group or a usual care group., Setting: Thirty-three general practices in the north-western region of the Netherlands., Participants: One hundred seventy community-dwelling adults, aged 75 and older, with subthreshold depression., Intervention: The bibliotherapy intervention consisted of an information leaflet and a self-help manual "Coping with Depression" adapted for the elderly., Measurements: Outcome measures after 3 months were a) change in depressive symptoms according to the Center for Epidemiologic Studies Depression Scale (CES-D) and b) the proportion of participants who scored a significant improvement on the CES-D., Results: One hundred forty-six (85.9%) of the 170 participants completed the baseline and follow-up measurements. The authors did not find any clinically relevant and statistically significant differences between the intervention group and the control group in the severity of the depressive symptoms., Conclusion: Bibliotherapy as a stand-alone intervention for the elderly (aged 75 years and older) did not reduce depressive symptoms more than usual care. This might indicate that bibliotherapy can only be effective for patients who are motivated and acknowledge their depression.

Objective: To identify associations of patient characteristics (predisposing, enabling and need factors) with guideline-concordant care for anxiety and depression in primary care., Design: Analysis of data from the Netherlands Study of Depression and Anxiety (NESDA)., Participants: Seven hundred and twenty-one patients with a current anxiety or depressive disorder, recruited from 67 general practitioners (GPs), were included., Measures: Diagnoses according to the Diagnostic and Statistic Manual of Mental Disorders, fourth edition (DSM-IV) were made using a structured and widely validated assessment. Socio-demographic and enabling characteristics, severity of symptoms, disability, (under treatment for) chronic somatic conditions, perceived need for care, beliefs and evaluations of care were measured by questionnaires. Actual care data were derived from electronic medical records. Criteria for guideline-concordant care were based on general practice guidelines, issued by the Dutch College of General Practitioners., Results: Two hundred and eighty-one (39%) patients received guideline-concordant care. High education level, accessibility of care, comorbidity of anxiety and depression, and severity and disability scores were positively associated with receiving guideline-concordant care in univariate analyses. In multivariate multi-level logistic regression models, significant associations with the clinical need factors disappeared. Positive evaluations of accessibility of care increased the chance (OR = 1.31; 95%-CI = 1.05-1.65; p = 0.02) of receiving guideline-concordant care, as well as perceiving any need for medication (OR = 2.99; 95%-CI = 1.84-4.85; p < 0.001), counseling (OR = 2.25; 95%-CI = 1.29-3.95; p = 0.005) or a referral (OR = 1.83; 95%-CI = 1.09-3.09; p = 0.02). A low educational level decreased the odds (OR = 0.33; 95%-CI = 0.11-0.98; p = 0.04) of receiving guideline-concordant care., Conclusions: This study shows that education level, accessibility of care and patients' perceived needs for care are more strongly associated with the delivery of guideline-concordant care for anxiety or depression than clinical need factors. Initiatives to improve GPs' communication skills around mental health issues, and to improve recognition of people suffering from anxiety disorders, could increase the number of patients receiving treatment for depression and anxiety in primary care.

Objective: Psychiatric consultation in primary care is meant to enhance and improve treatment for mental disorder in that setting. An estimate of the effect for different conditions as well as identification of particularly effective elements is needed., Methods: Database search for randomized controlled trials (RCTs) on psychiatric consultation in primary care. Validity assessment and data extraction according to Cochrane criteria were performed by independent assessors in duplicate. Meta-analysis was performed., Results: Data were collected from 10 RCTs with a total of 3408 included patients with somatoform disorder or depressive disorder, which compared psychiatric consultation to care as usual (CAU). Meta-analysis irrespective of condition showed a weighted mean indicating a combined assessment of illness burden as outcome of psychiatric consultation, compared to CAU, of 0.313 (95% CI 0.190-0.437). The effect was especially large in somatoform disorder (0.614; 95% CI 0.206-1.022). RCTs in which after the consult, consultation advice was given by means of a consultation letter, showed a combined weighted mean effect size of 0.561 (95% CI 0.337-0.786), while studies not using such a letter showed a small effect of 0.210 (95% CI 0.102-0.319). Effects are highest on utilization of health care services with 0.507 (95% CI 0.305-0.708)., Conclusion: Psychiatric consultation in the primary care setting is effective in patients with somatoform and depressive disorder. Largest effects are seen in reduction of utilization of health care services., (Copyright 2010 Elsevier Inc. All rights reserved.)

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: Panic disorder (PD) and generalized anxiety disorder (GAD) are two of the most disabling and costly anxiety disorders seen in primary care. However, treatment quality of these disorders in primary care generally falls beneath the standard of international guidelines. Collaborative stepped care is recommended for improving treatment of anxiety disorders, but cost-effectiveness of such an intervention has not yet been assessed in primary care. This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of a collaborative stepped care approach in the primary care setting for patients with PD and GAD compared with care as usual., Methods/design: The study is a two armed, cluster randomized controlled trial. Care managers and their primary care practices will be randomized to deliver either collaborative stepped care (CSC) or care as usual (CAU). In the CSC group a general practitioner, care manager and psychiatrist work together in a collaborative care framework. Stepped care is provided in three steps: 1) guided self-help, 2) cognitive behavioral therapy and 3) antidepressant medication. Primary care patients with a DSM-IV diagnosis of PD and/or GAD will be included. 134 completers are needed to attain sufficient power to show a clinically significant effect of 1/2 SD on the primary outcome measure, the Beck Anxiety Inventory (BAI). Data on anxiety symptoms, mental and physical health, quality of life, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months., Discussion: It is hypothesized that the collaborative stepped care intervention will be more cost-effective than care as usual. The pragmatic design of this study will enable the researchers to evaluate what is possible in real clinical practice, rather than under ideal circumstances. Many requirements for a high quality trial are being met. Results of this study will contribute to treatment options for GAD and PD in the primary care setting. Results will become available in 2011., Trial Registration: NTR1071.

Objective: A focus on the communicator competency is considered to be an important requirement to help physicians to acquire consultation skills. A feedback questionnaire, in which patients assess consultation skills might be a useful learning tool. An existing questionnaire on patient perception of patient-centeredness (PPPC) was adapted to cover the 'communicator' items in the competency profile. We assessed the face and content validity, the construct validity and the internal consistency of this new patient feedback on consultation skills (PFC) questionnaire., Methods: We assessed the face validity of the PFC by interviewing patients and general practice trainees (GPTs) during the developmental process. The content validity was determined by experts (n=10). First-year GPTs (23) collected 222 PFCs, from which the data were used to assess the construct validity (factor analysis), internal consistency, response rates and ceiling effects., Results: The PFC adequately covers the corresponding 'communicator' competency (face and content validity). Factor analysis showed a one-dimensional construct. The internal consistency was high (Cronbach's alpha 0.89). For the single items, the response rate varied from 89.2% to 100%; the maximum score (ceiling effect) varied from 45.5% to 89.2%., Conclusion: The PFC appears to be a valid, internally consistent instrument., Practical Implications: The PFC may be a valuable learning tool with which GPTs, other physicians and medical students can acquire feedback from patients regarding their consultation skills.

Background: 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., Methods: 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., Results: Almost everyone (89%) received one or more diagnoses at both measurements, and there was fair total agreement (kappa = 0.27). The best agreement was found for more severe threshold disorders [major depressive disorder (kappa = 0.58), dysthymia (kappa = 0.57), and generalized anxiety disorder (kappa = 0.59)], while we found indefinite results for the sub-threshold disorders [anxiety disorder not otherwise specified (NOS) (kappa =.30), minor depressive disorder (kappa = -0.03), and somatoform disorder NOS (kappa = 0.11)]., Conclusion: 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.

Objective: Anxiety and depressive disorders are widely prevalent, but patients are only treated in a minority of cases. In this study, the explanation of receiving mental health treatment is sought in predisposing and enabling characteristics and indicators for objective and self-perceived need., Methods: Cross-sectional analysis of data collected in the Netherlands Study of Depression and Anxiety (NESDA) among 743 persons with an anxiety and/or depression diagnosis as assessed by the CIDI. Receipt of mental health treatment was assessed in the face-to-face interview, as well as indicators of predisposing and enabling factors and variables evaluating need for care., Results: Of the total sample, 57% received treatment in the past 6 months in the general practice setting (50%) or the mental health care setting (14%). Younger patients, patients who evaluated their providers better on communicative abilities and patients who perceived mental health problems themselves had greater odds of having professional mental health contacts in the primary care setting. Confidence in professional help and higher severity of mental problems were associated with greater odds of having specialized mental health care., Conclusion: Receiving help for common mental disorders depends not only on the objective need of the patient but also at least as much on the patients' own recognition that their problems have a mental health origin. Furthermore, in primary care especially, the patients' judgment of their providers' affective abilities may be decisive for being treated. For receiving specialized care, patients are also directed by their confidence in professional help.

Background: Depression is a highly prevalent condition that is associated with high levels of work absenteeism and high health care costs. Most patients are treated in primary care. A large group of patients prefers psychological treatments to antidepressants., Aims of the Study: To systematically review the evidence for the cost-effectiveness of psychological treatments, psychotherapy and counselling, in comparison with usual care or antidepressant treatment in adult primary care patients with depression., Methods: A computer-assisted search of MEDLINE, EMBASE, CINAHL, PsycINFO, and the Cochrane Library was carried out. Two independent reviewers selected studies for the review, extracted data and assessed the methodological quality of the included studies., Results: Seven studies were included in the review. Forms of psychotherapy that were evaluated were cognitive behavioural therapy, interpersonal psychotherapy and couple therapy. Usual care generally consisted of care as usually provided by the general practitioner. No conclusion can be drawn on the cost-effectiveness of the above mentioned forms of psychotherapy in comparison with usual care or antidepressant treatment. The cost-effectiveness of counselling in comparison with usual care and antidepressant therapy is yet to be established. Meta-analyses showed that psychotherapy was significantly more expensive than usual care, but not significantly more expensive than antidepressant treatment. Counselling was associated with no statistically significant differences in costs and effects in comparison with usual care in the pooled analysis., Discussion: Based on this review, no firm conclusions on the cost-effectiveness of psychotherapy and counselling in primary care can be drawn. Most studies had methodological shortcomings, which limit the generalisibility of the results., Implications for Health Policies: Given the reluctance of patients to use antidepressants and the large economic impact of depression, policy makers have a need for well designed and sufficiently powered economic evaluations of psychological treatments. The available evidence seems to indicate that psychotherapy has more substantial clinical effects than counselling. Therefore, the emphasis should be on economic evaluations of forms of psychotherapy that have proved to be clinically effective., Implications for Further Research: There are indications that the cost-effectiveness of depression treatment on the whole may be improved by incorporating psychological treatments into enhanced care models, tailored to the needs of individual patients and/or by providing them by trained nurses instead of psychologists or psychotherapists. Further research should investigate these patient tailored, stepped care treatment modalities for depression treatment.

Background: Minor and mild-major depression are highly prevalent in primary care. There is insufficient evidence for the effectiveness of antidepressants in the treatment of minor and mild-major 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 Asberg 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 who were assigned to their preferred treatment (in particular to UCnoAD) were more often compliant and had better clinical outcomes., 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.

Objectives: Major depression is common in elderly patients. Interpersonal psychotherapy (IPT) is a potentially effective treatment for depressed elderly patients. The objective of this study was to evaluate the cost-effectiveness of IPT delivered by mental health workers in primary care practices, for depressed patients 55 years of age and older identified by screening, in comparison with care as usual (CAU)., Methods: We conducted a full economic evaluation alongside a randomized controlled trial comparing IPT with CAU. Outcome measures were depressive symptoms, presence of major depression, and quality of life. Resource use was measured from a societal perspective over a 12-month period by cost diaries. Multiple imputation and bootstrapping were used to analyze the data., Results: At 6 and 12 months, the differences in clinical outcomes between IPT and CAU were small and nonsignificant. Total costs at 12 months were Euros 5,753 in the IPT group and Euros 4,984 in the CAU group (mean difference, Euros 769; 95 percent confidence interval, -2,459 -3,433). Cost-effectiveness planes indicated that there was much uncertainty around the cost-effectiveness ratios., Conclusions: Based on these results, provision of IPT in primary care to elderly depressed patients was not cost-effective in comparison to CAU. Future research should focus on improvement of patient selection and treatments that have more robust effects in the acute and maintenance phase of treatment.

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: The main aims of this paper are to describe the setting and design of a Minimal Intervention in general practice for Stress-related mental disorders in patients on Sick leave (MISS), as well as to ascertain the study complies with the requirements for a cluster randomised controlled trial (RCT). The potential adverse consequences of sick leave due to Stress-related Mental Disorders (SMDs) are extensive, but often not recognised. Since most people having SMDs with sick leave consult their general practitioner (GP) at an early stage, a tailored intervention given by GPs is justified. We provide a detailed description of the MISS; that is more accurate assessment, education, advice and monitoring to treat SMDs in patients on sick leave. Our hypothesis is that the MISS will be more effective compared to the usual care, in reducing days of sick leave of these patients., Methods: The design is a pragmatic RCT. Randomisation is at the level of GPs. They received the MISS-training versus no training, in order to compare the MISS vs. usual care at patient level. Enrollment of patients took place after screening in the source population, that comprised 20-60 year old primary care attendees. Inclusion criteria were: moderately elevated distress levels, having a paid job and sick leave for no longer than three months. There is a one year follow up. The primary outcome measure is lasting full return to work. Reduction of SMD- symptoms is one of the secondary outcome measures. Forty-six GPs and 433 patients agreed to participate., Discussion: In our study design, attention is given to the practical application of the requirements for a pragmatic trial. The results of this cluster RCT will add to the evidence about treatment options in general practice for SMDs in patients on sick leave, and might contribute to a new and appropriate guideline. These results will be available at the end of 2006.

Patients' preferences in the treatment of depression are important in clinical practice and in research. Antidepressant medication is often prescribed, but adherence is low. This may be caused by patients preferring psychotherapy, which is often not available in primary care. In randomized clinical trials, patients' preferences may affect the external validity. The aim of this article is to study patients' preferences regarding psychotherapy and antidepressant medication and the impact of these preferences on treatment outcome. A systematic review of the literature was performed. The majority of patients preferred psychotherapy in all available studies. Antidepressants were often regarded as addictive and psychotherapy was assumed to solve the cause of depression. Discussing and supporting preferences as part of a quality improvement program of depression care, resulted in more patients receiving the treatment that was most suitable to them. In two patient-preference trials, preferences did not influence treatment outcome. It can be concluded that a substantial percentage of well-informed patients prefer psychotherapy. Patients with strong preferences, mostly for psychotherapy, are likely not to enter antidepressant treatment or randomized clinical trials if their preferences are not supported.

Objectives: Screening is advocated to improve the recognition of patients with major depression in primary care. Furthermore, disease management programmes are advocated to improve the quality of care and outcome for these patients. But is screening and the subsequent implementation of a disease management programme more effective than usual care?, Methods: Review of the literature on the effects of disease management programmes that include screening for major depression in general practice., Results: Six randomised controlled trials were identified in which the effectiveness of disease management programmes were studied in patients with major depression in primary care and compared with usual care. The majority of these, and especially the largest, showed positive effects on the recognition, diagnosis, treatment and outcome of patients. Populations in the US seem to benefit most., Conclusion: The results of disease management programmes for major depression in primary care that include screening are positive and are more effective than usual care. Therefore, if proceeded by screening, attention to the whole process of care for patients with major depression instead of paying attention to isolated elements of the process is justified.

In health care research, the patient-doctor relationship as perceived by the patient is considered important. Our aim was to develop and validate a questionnaire that assesses the Patient-Doctor Relationship, the Patient-Doctor Relationship Questionnaire (PDRQ-9). The PDRQ-9 was developed out of the Helping Alliance Questionnaire of Luborsky, a scale that measures the therapeutic alliance in psychotherapy. Its psychometric qualities and validity in general practice were assessed, with the collaboration of 110 general practice patients and 55 patients in an Epilepsy Clinic. Principal components analysis demonstrates a two-factorial structure, one related to the doctor, and one related to the medical symptoms of the patient. Both show high reliability but as the second factor explains only 9% of the variance, it is eliminated from the questionnaire. The PDRQ-9 provides researchers a brief measure of the therapeutic aspects of the patient-doctor relationship in the primary care setting. It is a valuable tool for scientific and practical purposes involving the monitoring of the patient-doctor relationship.

General practitioners (GPs) are recommended to use DSM-IV criteria to diagnose major depression in daily clinical practice. This implies the assessment of nine depressive symptoms and four additional criteria. A short structured interview has been developed to assess these symptoms and criteria, and a study was carried out to investigate the reliability and validity with which GPs can assess these symptoms and criteria and the DSM-IV diagnosis of major depression. In 14 general practices, 52 patients with symptoms of distress and depression were interviewed twice by their GP, with an interval of one to four days. Furthermore, the patients filled out three depression questionnaires. The reproducibility of eight symptoms and three additional criteria was moderate to good (kappa >0.40). The reproducibility of the depressive symptom count, that is necessary to arrive at a diagnosis of major depression, was such that in 75 percent of the patients the test-retest difference did not exceed one symptom. The reproducibility of the diagnosis of major depression was good (kappa 0.63). The validity of the diagnosis of major depression assessed by the GPs, as compared to results of the self-report depression questionnaires, was satisfactory (r 0.35-0.61). Diagnosing major depression in patients with depressive symptomatology just above or below the threshold of major depression warrants a certain amount of caution in general practice.

Background: Antidepressant use is often prolonged in patients with anxiety and/or depressive disorder(s) compared with recommendations in treatment guidelines to discontinue after sustained remission.Aim: To unravel the motivations of patients and GPs causing long-term antidepressant use and to gain insight into possibilities to prevent unnecessary long-term use.Design and Setting: Qualitative study using semi-structured, in-depth interviews with patients and GPs in the Netherlands.Method: Patients with anxiety and/or depressive disorder(s) (n = 38) and GPs (n = 26) were interviewed. Innovatively, the interplay between patients and their GPs was also investigated by means of patient-GP dyads (n = 20).Results: The motives and barriers of patients and GPs to continue or discontinue antidepressants were related to the availability of supportive guidance during discontinuation, the personal circumstances of the patient, and considerations of the patient or GP. Importantly, dyads indicated a large variation in policies of general practices around long-term use and continuation or discontinuation of antidepressants. Dyads further indicated that patients and GPs seemed unaware of each other's (mismatching) expectations regarding responsibility to initiate discussing continuation or discontinuation.Conclusion: Although motives and barriers to antidepressant continuation or discontinuation were related to the same themes for patients and GPs, dyads indicated discrepancies between them. Discussion between patients and GPs about antidepressant use and continuation or discontinuation may help clarify mutual expectations and opinions. Agreements between a patient and their GP can be included in a patient-tailored treatment plan. [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]