Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).

BACKGROUND: Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS: An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS: The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION: The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION: Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.

Improving suicide surveillance systems through the use of the Patient Health Questionnaire-9.

Suicide is a major public health problem worldwide and continues to be one of the main causes of death. Implementing surveillance strategies for suicidal thoughts and behaviours would make it possible to identify individuals at high risk of ending their lives by suicide. While a universal screening would be controversial, the increasing use of the 9-item version of the Patient Health Questionnaire (PHQ-9) in different healthcare settings, such as primary care or hospital emergency departments, offers an opportunity for testing its performance for suicide surveillance. Beyond being a screening of depression, the PHQ-9 has shown merit as a marker of suicidal thinking, thoughts of self-harm, and suicide. Implementing systematic surveillance strategies for suicide in different healthcare settings including data from the PHQ-9 might be an effective way to improve case detection. This could help to enhance the identification of highest risk population groups and, consequently, to avoid potentially preventable suicides.

Accuracy of Self-Reported Items for the Screening of Depression in the General Population.

INTRODUCTION: Though self-reported items (SRD, self-reported depression) are commonly used in health surveys and cohort studies, their metric properties as a depression indicator remain unclear. The aims were to evaluate the measurement properties of SRD using the Patient Health Questionnaire-8 (PHQ-8) as reference and to identify factors related to the agreement between both indicators. METHODS: Data from the European Health Interview Survey in Spain in 2014/2015 (n = 22,065) were analyzed. Two indicators of depression were considered: SRD based on two items yes/no (positive: both yes), and the PHQ-8 (positive ≥ 10). Socioeconomic factors and use of health services were considered as independent variables. The prevalence of depression, sensitivity, specificity, global agreement, and positive and negative predictive values (PPV and NPV) of SRDs were evaluated using the PHQ-8 as a reference. Logistic regression models were fitted to determine factors associated with the agreement between indicators. RESULTS: The prevalence of depression was lower when assessed with PHQ-8 (5.9%) than with SRD (7.7%). SRD sensitivity and PPV were moderate-low (52.9% and 40.4%, respectively) whereas global agreement, specificity, and NPV were high (92.7%, 95.1%, and 97.0%, respectively). Positive agreement was associated with marital status, country of birth, employment status, and social class. Negative agreement was related to all independent variables except country of birth. CONCLUSIONS: SRD items tend to overestimate the current prevalence of depression. While its use in health surveys and cohorts may be appropriate as a quick assessment of possible depression, due to their low sensitivity, its use in clinical contexts is questionable.

Catatonia in elderly psychiatric inpatients is not always associated with intense anxiety: Factor analysis and correlation with psychopathology.

OBJECTIVE: Catatonic stupor has been linked to extreme fear. Whether the underlying phenomenology of every catatonic dimension is intense anxiety or fear remains unknown. METHODS: One hundred and six patients aged ≥64 years were assessed for catatonia and clinical variables during the first 24 hours of admission. Two-sample t test were used to test for group differences. A principal component analysis was developed. Analysis of variance was performed to assess for differences in the diagnostic groups. Correlation coefficients were used to examine the association between catatonic dimensions and psychopathological variables. RESULTS: There were statistically significant differences between catatonic and non-catatonic patients in the Hamilton and NPI scores. The three factor-model accounted for 52.23% of the variance. Factor 1 loaded on items concerned with "excitement," factor 2 on "inhibition" items, and factor 3 on "parakinetic" items. There was a significant effect for factor 1 (F [5.36] = 2.83, P = .02), and not significant for factor 2 and factor 3. Compared with patients with depression, patients with mania scored significantly higher on factor "excitement" (P < .05). Factor 2 showed a moderate correlation with Hamilton total score (r = .346, P = .031) and Hamilton psychic score (r = .380, P = .017). CONCLUSIONS: Catatonic patients experienced more anxiety and hyperactivity. A three-factor solution provided best fit for catatonic symptoms. Patients with mania scored highest on Excitement, patients with depression on Inhibition, and patients with schizophrenia on Parakinetic. The main finding in this study was a positive moderate correlation between the Hamilton psychic score and the Inhibition factor score, meaning that not every catatonic dimension is associated to intense anxiety.

Changes in metabolites in the brain of patients with fibromyalgia after treatment with an NMDA receptor antagonist.

The aims of this work were to evaluate whether the treatment of patients with fibromyalgia with memantine is associated with significant changes in metabolite concentrations in the brain, and to explore any changes in clinical outcome measures. Magnetic resonance spectroscopy was performed of the right anterior and posterior insula, both hippocampi and the posterior cingulate cortex. Questionnaires on pain, anxiety, depression, global function, quality of life and cognitive impairment were used. Ten patients were studied at baseline and after three months of treatment with memantine. Significant increases were observed in the following areas: N-acetylaspartate (4.47 at baseline vs. 4.71 at three months, p = 0.02) and N-acetylaspartate+N-acetylaspartate glutamate in the left hippocampus (5.89 vs. 5.98; p = 0.007); N-acetylaspartate+N-acetylaspartate glutamate in the right hippocampus (5.31 vs 5.79; p = 0.01) and the anterior insula (7.56 vs. 7.70; p = 0.033); glutamate+glutamine/creatine ratio in the anterior insula (2.03 vs. 2.17; p = 0.022) and the posterior insula (1.77 vs. 2.00; p = 0.004); choline/creatine ratio in the posterior cingulate (0.18 vs. 0.19; p = 0.023); and creatine in the right hippocampus (3.60 vs. 3.85; p = 0.007). At the three-month follow-up, memantine improved cognitive function assessed by the Cognition Mini-Exam (31.50, SD = 2.95 vs. 34.40, SD = 0.6; p = 0.005), depression measured by the Hamilton Depression Scale (7.70, SD = 0.81 vs. 7.56, SD = 0.68; p = 0.042) and severity of illness measured by the Clinical Global Impression severity scale (5.79, SD = 0.96 vs. 5.31, SD = 1.12; p = 0.007). Depression, clinical global impression and cognitive function showed improvement with memantine. Magnetic resonance spectroscopy could be useful in monitoring response to the pharmacological treatment of fibromyalgia.

The burden of disease in Spain: Results from the Global Burden of Disease 2016. / La carga de enfermedad en España: resultados del Estudio de la Carga Global de las Enfermedades 2016.

BACKGROUND AND OBJECTIVES: The global burden of disease (GBD) project measures the health of populations worldwide on an annual basis, and results are available by country. We used the estimates of the GBD to summarise the state of health in Spain in 2016 and report trends in mortality and morbidity from 1990 to 2016. MATERIAL AND METHODS: GBD 2016 estimated disease burden due to 333 diseases and injuries, and 84 risk factors. The GBD list of causes is hierarchical and includes 3 top level categories, namely: 1) communicable, maternal, neonatal, and nutritional diseases; 2) non-communicable diseases (NCDs), and 3) injuries. Mortality and disability-adjusted life-years (DALYs), risk factors, and progress towards the sustainable development goals (SDGs) are presented based on the GBD 2016 data in Spain. RESULTS: There were 418,516 deaths in Spain in 2016, from a total population of 46.5 million, and 80.5% of them occurred in those aged 70 years and older. Overall, NCDs were the main cause of death: 388,617 (95% uncertainty interval 374,959-402,486), corresponding to 92.8% of all deaths. They were followed by 3.6% due to injuries with 15,052 (13,902-17,107) deaths, and 3.5% communicable diseases with 14,847 (13,208-16,482) deaths. The 5 leading specific causes of death were ischaemic heart disease (IHD, 14.6% of all deaths), Alzheimer disease and other dementias (13.6%), stroke (7.1%), chronic obstructive pulmonary disease (6.9%), and lung cancer (5.0%). Remarkable increases in mortality from 1990 to 2016 were observed in other cancers, lower respiratory infections, chronic kidney disease, and other cardiovascular disease, among others. On the contrary, road injuries moved down from 8th to 32nd position, and diabetes from 6th to 10th. Low back and neck pain became the number one cause of DALYs in Spain in 2016, just surpassing IHD, while Alzheimer disease moved from 9th to 3rd position. The greatest changes in DALYs were observed for road injuries dropping from 4th to 16th position, and congenital disorders from 17th to 35th; conversely, oral disorders rose from 25th to 17th. Overall, smoking is by far the most relevant risk factor in Spain, followed by high blood pressure, high body mass index, alcohol use, and high fasting plasma glucose. Finally, Spain scored 74.3 of 100 points in the SDG index classification in 2016, and the main national drivers of detrimental health in SDGs were alcohol consumption, smoking and child obesity. An increase to 80.3 points is projected in 2030. CONCLUSION: Low back and neck pain was the most important contributor of disability in Spain in 2016. There has seen a remarkable increase in the burden due to Alzheimer disease and other dementias. Tobacco remains the most important health issue to address in Spain.

Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.

BACKGROUND: Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. METHODS: This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework. DISCUSSION: EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.

Prevalence and characteristics of catatonia on admission to an acute geriatric psychiatry ward.

BACKGROUND: This study aims to describe the prevalence of catatonia in a population of older acute psychiatric inpatients according to different diagnostic criteria. Secondary objectives are: to compare the catatonic symptom profile, prevalence, and severity, in respect to the underlying aetiology, and to evaluate the association between catatonic and somatic comorbidity. METHODS: The study included 106 patients admitted to an acute geriatric psychiatry ward. Catatonia was assessed using the Bush Francis Catatonia Rating Scale (BFCRS). RESULTS: Catatonia was highly prevalent (n=42; 39.6%), even when using restrictive diagnostic criteria: Fink and Taylor (n=19; 17.9%) and DSM 5 (n=22; 20.8%). Depression was the most frequent psychiatric syndrome among catatonic patients (n=18; 42.8%). Catatonia was more frequent in depression (48.6%) and delirium (66.7%). Affective disorders showed a higher risk than psychotic disorders to develop catatonia (OR=2.68; 95% CI 1.09-6.61). This association was not statistically significant when controlling for dementia and geriatric syndromes. The most prevalent catatonic signs were excitement (64.3%), verbigeration (61.9%), negativism (59.5%), immobility/stupor (57.1%), and staring (52.4%). CONCLUSIONS: Catatonia in older psychiatric inpatients was highly prevalent. Depression was the most common psychiatric syndrome among catatonic patients, and catatonia was more frequent in depression and mania, as well as in delirium. Affective disorders were associated with a higher risk of developing catatonia compared to psychotic disorders. Somatic and cognitive comorbidity played a crucial aetiological role in catatonia in this series.

Cost-Utility of Group Acceptance and Commitment Therapy for Fibromyalgia Versus Recommended Drugs: An Economic Analysis Alongside a 6-Month Randomized Controlled Trial Conducted in Spain (EFFIGACT Study).

The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy (GACT) in patients with fibromyalgia (FM) compared with patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, a randomized controlled trial that focused on clinical outcomes. Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory, respectively. Analyses included quality-adjusted life years, direct and indirect cost differences, and incremental cost effectiveness ratios. A total of 156 FM patients were randomized (51 GACT, 52 RPT, 53 WL). GACT was related to significantly less direct costs over the 6-month study period compared with both control arms (GACT €824.2 ± 1,062.7 vs RPT €1,730.7 ± 1,656.8 vs WL €2,462.7 ± 2,822.0). Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications. The incremental cost effectiveness ratios were dominant in the completers' analysis and remained robust in the sensitivity analyses. In conclusion, acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM. PERSPECTIVE: Decision-makers have to prioritize their budget on the treatment option that is the most cost effective for the management of a specific patient group. From government as well as health care perspectives, this study shows that a GACT is more cost effective than pharmacological treatment in management of FM.

Cost-utility and biological underpinnings of Mindfulness-Based Stress Reduction (MBSR) versus a psychoeducational programme (FibroQoL) for fibromyalgia: a 12-month randomised controlled trial (EUDAIMON study).

BACKGROUND: The EUDAIMON study focuses on fibromyalgia syndrome (FMS), a prevalent chronic condition characterized by pain, fatigue, cognitive problems and distress. According to recent reviews and meta-analyses, Mindfulness-Based Stress Reduction (MBSR) is a promising therapeutic approach for patients with FMS. The measurement of biomarkers as part of the analysis of MBSR effects would help to identify the neurobiological underpinnings of MBSR and increase our knowledge of FMS pathophysiology. The main objectives of this 12-month RCT are: firstly, to examine the effectiveness and cost-utility for FMS patients of MBSR as an add-on to treatment as usual (TAU) versus TAU + the psychoeducational programme FibroQoL, and versus TAU only; secondly, to examine pre-post differences in brain structure and function, as well as levels of specific inflammatory markers in the three study arms and; thirdly, to analyse the role of some psychological variables as mediators of 12-month clinical outcomes. METHODS: Effectiveness, cost-utility, and neurobiological analyses performed alongside a 12-month RCT. The participants will be 180 adult patients with FMS recruited at the Sant Joan de Déu hospital (St. Boi de Llobregat, Spain), randomly allocated to one of the three study arms: TAU + MBSR vs. TAU + FibroQol vs. TAU. A comprehensive assessment to collect functional, quality of life, distress, costs, and psychological variables will be conducted pre-, post-intervention, and at 12-month post-intervention. Fifty per cent of study participants will be evaluated at pre- and post-treatment using Voxel-Based Morphometry, Diffusion Tensor Imaging, pseudo-continuous Arterial Spin Labeling, and resting state fMRI. A cytokine multiplex kit of high-sensitivity will be applied (cytokines IL-6, IL-8, IL-10 + high-sensitivity CRP test). DISCUSSION: The findings obtained from this RCT will indicate whether MBSR is potentially cost-effective for FMS and contribute to knowledge of any brain and inflammatory changes associated with MBSR in FMS patients. Specifically, we will determine whether there are morphometric and functional changes associated with participation in MBSR in brain regions related to meta-awareness, body awareness, memory consolidation-reconsolidation, emotion regulation and in networks postulated to underpin the sensory-discriminative, cognitive-evaluative and affective-motivational aspects of the pain experience. TRIAL REGISTRATION: NCT02561416 . Registered 23 September 2015.

Functional Status, Quality of Life, and Costs Associated With Fibromyalgia Subgroups: A Latent Profile Analysis.

OBJECTIVES: Although fibromyalgia syndrome (FM) is considered a heterogeneous condition, there is no generally accepted subgroup typology. We used hierarchical cluster analysis and latent profile analysis to replicate Giesecke's classification in Spanish FM patients. The second aim was to examine whether the subgroups differed in sociodemographic characteristics, functional status, quality of life, and in direct and indirect costs. MATERIALS AND METHODS: A total of 160 FM patients completed the following measures for cluster derivation: the Center for Epidemiological Studies-Depression Scale, the Trait Anxiety Inventory, the Pain Catastrophizing Scale, and the Control over Pain subscale. Pain threshold was measured with a sphygmomanometer. In addition, the Fibromyalgia Impact Questionnaire-Revised, the EuroQoL-5D-3L, and the Client Service Receipt Inventory were administered for cluster validation. RESULTS: Two distinct clusters were identified using hierarchical cluster analysis ("hypersensitive" group, 69.8% and "functional" group, 30.2%). In contrast, the latent profile analysis goodness-of-fit indices supported the existence of 3 FM patient profiles: (1) a "functional" profile (28.1%) defined as moderate tenderness, distress, and pain catastrophizing; (2) a "dysfunctional" profile (45.6%) defined by elevated tenderness, distress, and pain catastrophizing; and (3) a "highly dysfunctional and distressed" profile (26.3%) characterized by elevated tenderness and extremely high distress and catastrophizing. We did not find significant differences in sociodemographic characteristics between the 2 clusters or among the 3 profiles. The functional profile was associated with less impairment, greater quality of life, and lower health care costs. DISCUSSION: We identified 3 distinct profiles which accounted for the heterogeneity of FM patients. Our findings might help to design tailored interventions for FM patients.

Quality of Life and Hormonal, Biochemical, and Anthropometric Profile Between Olanzapine and Risperidone Users.

This cross-sectional study compared quality of life and side effects in 108 users of olanzapine or risperidone suffering schizophrenia and being attended at psychiatric ambulatory services in Rio Grande do Norte, Brazil. Economic, socio-demographic, anthropometric, biochemical, and hormonal variables were compared. The EuroQoL Five-Dimension Scale (EQ-5D) was used to evaluate quality of life, and side effects were assessed using the Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale and the Simpson-Angus Scale. Data were analysed using the χ(2) test and Student's t test, with a significance level of 5 %.The household incomes of approximately 80 % of patients were <2.0 minimum wages ($678). Anthropometric variables (waist circumference, hip circumference, weight, waist-to-hip ratio) and systolic and diastolic blood pressure were noted among male olanzapine users (all p < 0.05). EQ-5D scores showed that olanzapine use significantly impacted self-help ability (p < 0.001). Risperidone users had a mean quality-adjusted life year value of 1. Mean total Simpson-Angus Scale scores was 0.38 for olanzapine users and 0.11 for risperidone users (p < 0.02). Significant differences in UKU were observed for the following items: asthenia/lassitude/fatigue (higher among olanzapine users, p = 0.02), dystonia (higher among olanzapine users, p = 0.01), tremors (higher among olanzapine users, p = 0.03), gynecomastia (higher among risperidone users, p < 0.02), and ejaculatory dysfunction (higher among risperidone users, p < 0.02). Olanzapine users had impaired quality of life, which can be explained in part by adverse motor, biochemical, and hormonal effects characteristic of metabolic syndrome.

Cost-utility of cognitive behavioral therapy versus U.S. Food and Drug Administration recommended drugs and usual care in the treatment of patients with fibromyalgia: an economic evaluation alongside a 6-month randomized controlled trial.

INTRODUCTION: Cognitive behavioral therapy (CBT) and U.S. Food and Drug Administration (FDA)-recommended pharmacologic treatments (RPTs; pregabalin, duloxetine, and milnacipran) are effective treatment options for fibromyalgia (FM) syndrome and are currently recommended by clinical guidelines. We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT (combination of pregabalin + duloxetine) and usual care (TAU) groups in the treatment of FM. METHODS: The economic evaluation was conducted alongside a 6-month, multicenter, randomized, blinded, parallel group, controlled trial. In total, 168 FM patients from 41 general practices in Zaragoza (Spain) were randomized to CBT (n = 57), RPT (n = 56), or TAU (n = 55). The main outcome measures were Quality-Adjusted Life Years (QALYs, assessed by using the EuroQoL-5D questionnaire) and improvements in health-related quality of life (HRQoL, assessed by using EuroQoL-5D visual analogue scale, EQ-VAS). The costs of healthcare use were estimated from patient self-reports (Client Service Receipt Inventory). Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves (CEACs). RESULTS: On average, the total costs per patient in the CBT group (1,847 €) were significantly lower than those in patients receiving RPT (3,664 €) or TAU (3,124 €). Patients receiving CBT reported a higher quality of life (QALYs and EQ-VAS scores); the differences between groups were significant only for EQ-VAS. From a complete case-analysis approach (base case), the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed, by using both QALYs and EQ-VAS as outcomes. These findings were confirmed by bootstrap analyses, net-benefit curves, and CEACs. Two additional sensitivity analyses (intention-to-treat analysis and per-protocol analysis) indicated that the results were robust. The comparison of RPT with TAU yielded no clear preference for either treatment when using QALYs, although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS. CONCLUSIONS: Because of lower costs, CBT is the most cost-effective treatment for adult FM patients. Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10804772. Registered 29 September 2008.

Risk factors for the onset of panic and generalised anxiety disorders in the general adult population: a systematic review of cohort studies.

BACKGROUND: We aimed to assess available evidence on risk factors associated with the onset of panic disorder (PD) and/or generalised anxiety disorder (GAD) in cohort studies in the general adult population. METHODS: Systematic review using MEDLINE, PsycINFO and Embase. Search terms included panic disorder, generalised anxiety disorder, cohort studies and risk factors. RESULTS: We finally selected 21 studies, involving 163,366 persons with a median follow-up of 5 years. 1) Sociodemographic factors: PD was associated with age, female gender, and few economic resources. GAD was associated with age, non-Hispanics and Blacks, being divorced or widowed, and few economic resources. 2) Psychosocial factors: PD was associated with smoking and alcohol problems. GAD was associated with stressful life events in childhood and adulthood, and personality. 3) Physical and mental health factors: PD was associated with the number of physical diseases suffered and the joint hypermobility syndrome. PD was also associated with a parental history of mental disorders, as well as with other anxiety disorders and other mental health problems in the person affected. GAD was associated with a parental history of mental disorders, as well as with other anxiety disorders and other mental health problems in the person affected, plus already having received psychiatric care. LIMITATIONS: Few studies examined the same risk factors. CONCLUSIONS: Sociodemographic, psychosocial and mental-physical health risk factors were determinant for the onset of PD and GAD in the general adult population. These findings could be useful for developing preventive interventions in PD and GAD.

Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study).

In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment.

Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial.

Studies of estrogen therapy in postmenopausal women provide evidence of an effect of sex hormones on cognitive function. Estrogen has demonstrated some utility in the prevention of normal, age-related decline in cognitive functions, especially in memory. The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator (SERM), appears to act similarly to conjugated estrogens on dopamine and serotonin brain systems, and may be a better option since it lacks the possible negative effects of estrogen on breast and uterine tissue. We assessed the utility of raloxifene as an adjuvant treatment for cognitive symptoms in postmenopausal women with schizophrenia in a 12-week, double-blind, randomized, placebo-controlled study. Patients were recruited from both the inpatient and outpatient departments. Thirty-three postmenopausal women with schizophrenia (DSM-IV) were randomized to receive either adjuvant raloxifene (16 women) or adjuvant placebo (17 women) for three months. The main outcome measures were: Memory, attention and executive functions. Assessment was conducted at baseline and week 12. The total sample is homogenous with respect to: age, years of schooling, illness duration, baseline symptomatology and pharmacological treatment. The addition of raloxifene (60 mg) to regular antipsychotic treatment showed: we found significant differences in some aspects of memory and executive function in patients treated with raloxifene. This improvement does not correlate with clinical improvement. The use of raloxifene as an adjuvant treatment in postmenopausal women with schizophrenia seems to be useful in improving cognitive symptoms.

Dimensionality, reliability, and validity of the revised fibromyalgia impact questionnaire in two Spanish samples.

OBJECTIVE: The present study attempted to fill a research gap by performing the first dimensionality analysis of the Revised Fibromyalgia Impact Questionnaire (FIQR) using exploratory and confirmatory techniques. A second objective was to report on the reliability and construct validity of the FIQR in Spanish patients. METHODS: FIQR data from a sample of adult fibromyalgia patients (n = 113) were analyzed using principal components analysis (PCA). Subsequently, a set of confirmatory factor analyses (CFAs) was conducted in another sample (n = 179) to analyze the goodness of fit of various factor models. FIQR reliability was assessed by computing Cronbach's alpha and coefficient H. Construct validity was evaluated by comparing the FIQR scores of participants categorized by employment status. RESULTS: According to the PCA, the FIQR structure might be described as having 1 global factor of functional impairment. Although subsequent CFAs confirmed that 1 factor accounted for the greatest proportion of common variance in the FIQR items, a confirmatory bifactor analysis indicated that the items were multidimensional because of their simultaneous significant loading on specific factors. The Cronbach's alpha values of the FIQR domains were very good (>0.80) and the H estimate for the FIQR total score was excellent (0.93). Overall, the FIQR domains were able to distinguish between patients differing in employment status (working outside the home versus on sick leave). CONCLUSION: Our results indicate that the Spanish version of the FIQR has a complex factor structure, has excellent reliability, and shows good construct validity.

Cost-utility of a psychoeducational intervention in fibromyalgia patients compared with usual care: an economic evaluation alongside a 12-month randomized controlled trial.

OBJECTIVE: To determine the effectiveness of adding psychoeducational treatment implemented in general practice to usual care for patients with fibromyalgia (FM), and to analyze the cost-utility of the intervention from health care and societal perspectives. METHODS: Twelve-month randomized controlled trial. A total of 216 primary care patients meeting the American College of Rheumatology criteria for FM participated in the study. The intervention included 9, 2-hour sessions of psychoeducation (5 sessions of education about the illness+4 sessions of autogenic relaxation) added to usual care provided by a multidisciplinary group in general practice was compared to usual care in the public health system. RESULTS: At 12-month follow-up, patients who received psychoeducation showed greater improvement in global functional status (Cohen d=0.36; -2.49 to 3.81), physical functioning (Cohen d=0.56; 0.08 to 1.00), days feeling well (Cohen d=0.40; -0.16 to 1.02), pain (Cohen d= 0.35; -0.04 to 0.80), morning fatigue (Cohen d=0.24; -0.20 to 0.76), stiffness (Cohen d=0.34; -0.10 to 0.87), and depression (Cohen d=0.30; -0.26 to 0.93). Mean incremental cost per person receiving the intervention was &OV0556;-215.49 (-615.13 to 287.81) from the health care perspective, and &OV0556;-197.32 (-785.12 to 395.74) from the societal perspective. The incremental gain in quality-adjusted life-years per person was 0.12 (0.06 to 0.19), yielding a "dominant" intervention from both perspectives. The sensitivity analysis suggested that the intervention was cost-effective even imputing all missing data. DISCUSSION: Our findings demonstrate the long-term clinical effectiveness of a psychoeducational treatment program for FM implemented at primary care level and the cost-utility from a health care and societal perspective. TRIAL REGISTRATION: NCT00550966.

Clinical dimensions of fibromyalgia symptoms and development of a combined index of severity: the CODI index.

BACKGROUND: Although a large body of work indicates that fibromyalgia (FM) is not a discrete entity, few studies have attempted to classify the heterogeneity of FM symptoms. The objectives of the present study were to confirm the existence of two latent dimensions underlying FM symptoms (Core-FM symptoms and Distress) by means of factor analysis techniques, and to develop and validate a new combined index of symptom severity (the CODI). METHODS: We analyzed and combined the baseline scores on six visual analog scales of the FIQ (pain, general fatigue, morning fatigue, stiffness, anxiety, and depression) and on the STAI-T (trait anxiety) of 216 Spanish patients diagnosed with FM (97.7% women) who were participating in a randomized, controlled trial. RESULTS: The principal component analysis indicated the presence of two correlated factors (labeled as Core-FM symptoms and Distress) that explained 64% of total variance. The subsequent confirmatory factor analysis yielded more empirical support for the two-factor model than the one-factor model (all items loading on one latent dimension). The two factors possessed adequate internal consistency and construct validity given the pattern of significant correlations with the Euroqol items. The Core-FM dimension had a stronger relationship with mobility, self-care, usual activities, and pain/discomfort than with anxiety/depression, whereas the Distress dimension showed the opposite pattern. Finally, summing the standardized scores of the two dimensions, a new combined index of symptom severity (the CODI) was developed. CONCLUSION: The clinical implications and utility of the CODI are discussed in relation to previous research on FM.

Perceived injustice in fibromyalgia: psychometric characteristics of the Injustice Experience Questionnaire and relationship with pain catastrophising and pain acceptance.

OBJECTIVE: To validate a Spanish version of the Injustice Experience Questionnaire (IEQ), a measure of perceived injustice, in a fibromyalgia sample and to examine its relationship with pain catastrophising and pain acceptance. METHODS: The IEQ was administered along with the Pain Visual Analogue Scale, the Fibromyalgia Impact Questionnaire, the Hospital Anxiety and Depression Scale, the Pain Catastrophizing Scale (PCS) and the Chronic Pain Acceptance Questionnaire (CPAQ) to 250 primary care patients with fibromyalgia. RESULTS: The IEQ had good test-retest reliability (intraclass correlation coefficient=0.98) and internal consistency (Cronbach's α=0.92). The factor structure obtained was similar to the original validation study. The multiple regression analyses showed that perceived injustice (PI) accounted for significant pain-related outcomes after controlling pain intensity, PCS and CPAQ. Principal component analysis of both the IEQ and the CPAQ taken together showed that the two constructs do not represent opposite extremes of the same dimension. CONCLUSION: The IEQ is a reliable assessment tool for measuring PI among patients with fibromyalgia. PI seems to be distinct from catastrophising, although the two constructs are very similar. The factor analysis showed that PI and acceptance represent related constructs, and this entails relevant implications for therapy, as acceptance-based interventions would be appropriate.