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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]

Abstract: Objective: This paper describes the rationale and methodology of the PROSPECTS study, a study which aims to assess the course and prognosis of medically unexplained physical symptoms (MUPS), in terms of symptom severity and physical and social functioning. Additionally, it aims to identify different course types and to determine which factors are associated with these course types. Based on these factors, one or more prediction models will be developed. Methods: This study is a prospective, multicenter longitudinal cohort study with 1 baseline and 4 follow-up measurements during a 3year period. 450 MUPS patients (age 18–70years) will be included, divided over a primary care group, recruited in general practices, and a secondary/tertiary care group, recruited in specialized MUPS care programs. Main study parameters/endpoints: Primary outcome measures are severity of symptoms and degree of functional impairment. Secondary outcome measures are health care consumption and level of depressive symptoms and anxiety. Potential predictors are based on current theoretical models describing the perpetuation of MUPS and include somatic, psychological and social factors. Latent Class Growth Mixture Modeling will be used to identify distinct course types. Logistic regression analysis will be used to identify risk factors associated with these course types. Finally, one or more multivariate prediction models for the course of MUPS will be developed and tested. Conclusion: The PROSPECTS study aims to enhance our insight into the course of MUPS, thus contributing to better recognition of future patients at risk for persistent MUPS. [Copyright &y& Elsevier]

Abstract: Objective: In an earlier study, we found that cognitive–behavioral therapy (CBT) delivered by general practitioners (GPs) for fatigue among employees on sick leave was not effective after 12 months. In this study we aim to assess the long-term efficacy of CBT by GPs for fatigue. It was hypothesized that the intervention could prevent deterioration as well as relapse of fatigue complaints and relapse into absenteeism in the long term. Methods: Patients who participated in the original randomized controlled trial were followed up 4 years later. Fatigue and absenteeism were the main outcomes. Results: Fatigue and absenteeism were high in the intervention and control groups at the 4-year follow-up. There was no significant difference between the intervention group and the control group on fatigue and absenteeism. The intervention group however tended toward less-favorable outcomes as compared with the control group. Conclusions: Like that of chronic fatigue syndrome, the prognosis of less-advanced fatigue is rather poor. CBT delivered by GPs is not effective in the long term. [Copyright &y& Elsevier]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Highlights from the article: To examine the effectiveness of an augmented Problem-Solving Treatment (PST) intervention delivered by mental health nurse practitioners (MHNPs) to patients with undifferentiated somatoform disorder (USD), compared to usual care. 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).

Objectives This study aimed to identify and characterize homogeneous subgroups of individuals with distinct trajectories of physical functioning (PF) and to examine prognostic indicators of deterioration in PF in a highly heterogeneous population of older adults with joint pain and comorbidity. Study design A prospective cohort study among 407 older adults with joint pain and comorbidity provided data over a period of 18 months, with 6 month time-intervals. We used latent class growth modelling (LCGM) to identify underlying subgroups (clusters) with distinct trajectories of PF. Next, we characterized these subgroups and applied multivariable logistic regression analysis to identify prognostic indicators for deterioration in PF. Main outcome measures We measures PF with the RAND-36 PF subscale and several potential sociodemographic, physical and psychosocial prognostic indicators. Results LCGM identified three clusters. Cluster 1 'good PF' contained 140 participants with good baseline PF and small improvements over time. Cluster 2 'moderate PF' contained 130 participants with moderate baseline PF and deterioration over time. Cluster 3 'poor PF' contained 137 participants with poor baseline PF and deterioration over time. After backward selection, the final model that could best distinguish between improved participants (cluster 1) and deteriorated participants (cluster 2-3) included the following prognostic indicators: higher age, more depressive symptoms, less perceived self-efficacy and more activity avoidance. Conclusions Older adults with joint pain and comorbidity either improved or deteriorated in PF over time. The prognostic model facilitates the classification of patients, the provision of more accurate information about prognosis and helps to narrow the focus to the high risk group of poor PF. [ABSTRACT FROM AUTHOR]