Clinical, economic, and humanistic impact of a multidisciplinary medication review with follow-up for anticoagulated patients treated with vitamin K antagonists in primary care: A cluster randomised controlled trial.

BACKGROUND: Interdisciplinary collaboration between general practitioner, nurses and pharmacists can favour the control of patients treated with vitamin K antagonists (VKA), increasing their safety and effectiveness. The aim of the study was to evaluate the impact of pharmaceutical interventions on patients treated with VKA within the framework of a Pharmacotherapeutic Follow-up service on clinical, economic and humanistic outcomes. METHODS: Controlled and randomized study in patients from two health areas of Zaragoza in treatment with VKA with Time in Therapeutic Range (TTR) according to the Rosendaal method less than 70% in the last 6 months. Patients were recruited at the pharmacy and assigned to two groups: control and intervention. A Pharmacotherapeutic Follow-up Program was established for the intervention group for 6 months. The outcome variables were INR stability, pharmacological adherence, vitamin K intake, knowledge about the use of acenocoumarol, quality of life, satisfaction with treatment, associated costs and avoided costs. A descriptive analysis was performed, and the Students' T test or Mann-Whitney U test was used for the association between quantitative variables and Chi-square or Fisher's test for qualitative variables. RESULTS: A total of 123 patients were included, 65 in the intervention group (IG) and 58 in the control group (CG). A total of 108 interventions were conducted (1.7 interventions/patient) and the most common were those related to the proper taking of medications (41.0%). In IG, TTR (p = 0.019), adherence to treatment (p = 0.038) and knowledge about acenocoumarol (p = 0.031) improved, compared to CG. A higher proportion of patients in IG achieved a TTR>65% (p = 0.024). In addition, patients whose interventions were accepted by the physician (p = 0.027) and those who received vitamin K optimization interventions (p = 0.003) achieved TTR>65% in greater proportion. CONCLUSIONS: Community pharmacist medication review, in collaboration with general practitioners improve knowledge and adherence of patients treated with oral anti-vitamin K agents and enhances the achievement of their therapeutic INR ranges. Investment needed to achieve this clinical impact is low and patient satisfaction is high. TRIAL REGISTRATION: This study has been registered with Clinical Trials.gov dated 25/05/2017: NCT03154489.

Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: A randomized controlled trial.

BACKGROUND: The high prevalence of depression is partly attributable to the poor response of patients to first-line antidepressants. Multimodal programs that promote a healthy lifestyle are successful in treating depression when used as a complementary therapy, but their medium- and long-term benefits have not been demonstrated for patients with treatment-resistant depression (TRD). The main aim of this study was to compare the effectiveness of a lifestyle modification program (LMP) with mindfulness-based cognitive therapy (MBCT) and a placebo-control (written suggestions for lifestyle changes) in Spanish patients with TRD. METHODS: This controlled clinical trial randomized 94 patients with TRD into 3 arms. The primary outcome was the Beck Depression Inventory-II (BDI-II) score at baseline, 2, 6 and 12 months. The secondary outcomes were changes in scores that evaluated quality-of-life, adherence to the Mediterranean diet, physical activity, and social support. RESULTS: Relative to the placebo group, the LMP and MBCT groups had significantly better quality of life (p = 0.017; p = 0.027), and the LMP group had significantly better adherence to the Mediterranean diet (p<0.001) and reduced use of antidepressants (p = 0.036). However, the three groups showed no significant differences in BDI-II score. LIMITATIONS: Only about half of the planned 180 patients were recruited, in part due to the COVID-19 pandemic. CONCLUSIONS: There was no evidence that the LMP treatment significantly reduced symptoms of depression relative to the other groups during the COVID-19 lockdown.

Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol.

INTRODUCTION: Treatment-resistant depression (TRD) has a high prevalence and can be exacerbated by poor physical health and economic hardships, which have become common stressors during the current COVID-19 pandemic. The therapeutic approaches used to treat these patients are not always available, may be not be accepted by some patients, and often require face-to-face interactions. OBJECTIVE: The main aim of this study will be to evaluate the effectiveness of an Internet-based adjuvant lifestyle-based intervention for patients with TRD. METHODS: This will be a parallel, randomized, and controlled clinical trial. A total of 180 patients with TRD will be randomly allocated (1:1:1) to 1 of 3 groups: treatment prescribed by the mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group). We will perform this study during the COVID-19 pandemic, and will administer interventions by teletherapy, and contact participants by telephone calls, text messages, and/or teleconferences. We will collect patient data using questionnaires administered at baseline, immediately after the intervention, and after 6 and 12 months. The primary outcome will be score on the Beck Depression Inventory-II. The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire. DISCUSSION: Patients with TRD are especially vulnerable when face-to-face psychotherapy is unavailable. The main strength of the proposed study is the novelty of the intervention to be used as an adjuvant therapy. Our results may provide guidance for treatment of patients with TRD in future situations that require lockdown measures. CLINICALTRIALS REGISTRATION NUMBER: NCT04428099.

Multiple risk behaviour intervention to prevent depression in primary care.

BACKGROUND: Primary care is the ideal setting for promotion and prevention intervention. Multiple risk behaviour interventions present several advantages over single-risk lifestyle interventions. Multiple risk behaviour interventions could be easily implemented in primary care to prevent non-communicable disease and depression. AIM: To test the effectiveness of a multiple risk behaviour intervention to promote Mediterranean diet, physical activity, and/or smoking cessation in people attending Spanish primary health care with incidence of depression and symptoms of depression. METHOD: This was a secondary analysis of the EIRA study that aims to test the effectiveness of a multiple risk behaviour intervention to promote healthy lifestyles. Twenty-six primary care centres were randomised to receive multiple risk behaviour intervention or usual care. The multiple risk behaviour intervention included individual sessions, group sessions, communitarian activities, and SMS reception. Participants were followed for 10-14 months. The primary outcomes of this study were incidence of depression and reductions of depressive symptoms. RESULTS: Three thousand and sixty-seven participants were included. Females accounted for 45.13% and 93.88% were Spanish. Age varied between 45 and 75 years old. The effectiveness of the intervention will be calculated using the Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview ( CIDI) depression section. Linear and logistic regression will be used to create predictive models. CONCLUSION: Primary care is the most accessible service in the health system for patients. Hence primary care is the ideal setting for health education, promotion, and prevention interventions. This study will provide high-quality evidence about the effectiveness of multiple risk behaviour interventions over depression prevention.

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.

Storytelling: una metodología de aprendizaje activo para la enseñanza de la psicología social en la educación superior / Storytelling: a methodology for active learning in Social Psychology teaching

En los últimos años la educación superior está promoviendo el uso de metodologías activas para la mejora del proceso de enseñanza-aprendizaje. En este artículo se analiza la utilidad del storytelling en la enseñanza de Psicología Social. Con este fin, 363 estudiantes universitarios participaron en la investigación, realizando una práctica grupal en la que debían escribir una historia utilizando conceptos de la asignatura, elaborar un informe explicativo, y leer las historias de otro grupo. Asimismo, cumplimentaron unos cuestionarios de valoración tanto de la práctica de storytelling como de otras dos representativas de la asignatura. La metodología empleada fue tanto cuantitativa como cualitativa. Los resultados muestran que el storytelling es percibido por los estudiantes como útil y es mejor valorado que los ejercicios de comparación, además de predecir el rendimiento académico (calificaciones en el examen teórico). Por último, se debaten las limitaciones del estudio (como la ausencia de grupo control) y las oportunidades de investigación futura, generalizando a otras áreas de conocimiento e incorporando una exposición pública de las historias desarrolladas

In recent years, higher education is promoting the use of active methodologies to improve the teaching-learning process. This paper analyzes the usefulness of storytelling in Social Psychology teaching. To that end, 363 university students participated in the research, performing a group exercise in which they had to write a story using concepts of Social Psychology, prepare an explanatory report, and read the stories of another group. Moreover, they also completed questionnaires assessing both the storytelling exercise and two other representative exercises of the subject. The methodology used was both quantitative and qualitative. The results show that storytelling is perceived as useful and it's valued higher than the comparison exercises by the students, in addition to predicting the academic performance (grades in the theory test). Finally, the limitations of the study are discussed, such as the absence of a control group and opportunities for further research, and also generalizing to other areas of knowledge and incorporating a public presentation of the stories

Prescripción de ejercicio físico en la depresión por parte de Médicos de Familia. Factores involucrados / Prescrição de exercício físico na depressao por parte de médicos de família. factores envolvidos / Exercise prescription for depression by general practitioners, factors involved

El problema del sedentarismo es acuciante en sociedades desarrolladas y sus consecuencias para la salud de la población constituyen uno de los principales problemas de salud pública actuales. La depresión es un motivo de consulta muy habitual en las consultas de atención primaria de países occidentales. Se ha planteado la prescripción de ejercicio físico como una estrategia antidepresiva útil en depresiones leves-moderadas, con frecuencia de forma complementaria a los tratamientos de primera elección. Sin embargo, los médicos de atención primaria no siempre lo prescriben y se desconoce de qué depende que lo hagan. Contribuir a aclarar esta cuestión es el objetivo del presente trabajo. Nuestra hipótesis era que el grado de prescripción depende de sus opiniones y experiencia sobre el tratamiento de la depresión.Se trata de un estudio descriptivo transversal en el que participaron 13 centros de salud. Utilizamos el cuestionario Depression Questionaire Attitude para valorar la actitud de los médicos hacia la depresión, y recogimos otras variables relacionadas con la importancia que otorgaban al ejercicio físico y a otros aspectos del estilo de vida en la salud física y mental. Los resultados confirman que la actitud de los médicos frente a la depresión influye en su disposición a recomendar ejercicio físico. Además, los médicos de atención primaria con menos años de práctica profesional valoran más el papel del ejercicio físico en la salud, tanto en la depresión como en otras patologías médicas. También se observa una correlación entre la importancia que se da al ejercicio físico en la salud y la que se da a otros factores ligados al estilo de vida, especialmente la dieta. Se concluye que aunque la utilidad de recomendar ejercicio físico en la depresión va acercándose al mismo nivel de importancia que en otros problemas de salud, su empleo por parte de los médicos de atención primaria es muy mejorable. Por ello, es importante insistir en la necesidad de ofrecer apoyo y programas de formación continuada a los médicos de atención primaria para ayudarles en este propósito (AU)

A sedentary lifestyle is an urgent problem in developed societies and its consequences are one of the main current problems in public health. Depression is a common reason to attend primary care in Western countries. In many cases of low and mild depression, exercise is recommended as a complement to the main therapy: Psychotherapy and/or pharmacotherapy. Nevertheless, general practitioners do not always recommend exercise to depressive patients and it is unknown why they do not. The main aim of our study was to clarify how the degree of prescribing exercise relies on a general practitioner’s opinion and experience in depression treatment. A cross-sectional design was undertaken in 13 public health centers. The Depression Attitude Questionnaire (DAQ) was used to evaluate general practitioners’ attitude towards depression; other variables related to the importance accorded to physical exercise; and other lifestyle aspects of physical and mental health. Our results show that general practitioners’ attitude towards depression influence their willingness to recommend exercise. Moreover, less experienced general practitioners (in years) tend to appreciate the importance of exercise in health, not only in depression. A positive relationship was found between importance of exercise and importance accorded to other factors linked to lifestyle, especially diet. Although recommendation of exercise in depression is similar to other medical conditions, its prescription may be improved. Hence, it is important to point out the need for education programs for general practitioners, in order to improve their capacity to deal with their task (AU)

O problema do sedentarismo é premente nas sociedades desenvolvidas e as suas consequências para a saúde da população constituem umdos principais problemas de saúde pública actuais. A depressão é um motivo muito habitual nas consultas de cuidados primários nos países ocidentais.Foi delineada a prescrição de exercício físico como uma estratégia antidepressiva útil em depressões leves-moderadas, de forma complementar aostratamentos de primeira escolha. Contudo, os médicos de cuidados primários nem sempre o prescrevem e desconhece-se o porquê de o fazerem. Contribuirpara clarificar esta questão é o objectivo do presente trabalho. A nossa hipótese era que o grau de prescrição depende das suas opiniões e experiênciasno tratamento da depressão. Trata-se de um estudo descritivo transversal no qual participaram 13 centros de saúde. Utilizámos o questionário DepressionQuestionaire Attitudepara avaliar a atitude dos médicos face à depressão e medimos outras variáveis relacionadas com a importância que atribuíam aoexercício físico e a outros aspectos do estilo de vida na saúde física e mental. Os resultados confirmam que a atitude dos médicos face à depressão influína sua disposição para recomendar exercício físico. Adicionalmente, os médicos de cuidados primários com menos anos de prática profissional valorizammais o papel do exercício físico na saúde, tanto na depressão como noutras patologias médicas. Também se observa uma correlação entre a importânciaque se dá ao exercício físico na saúde e à que se dá a outros factores ligados ao estilo de vida, especialmente à dieta. Conclui-se que apesar da utilidadede recomendar exercício físico na depressão se ir aproximando do nível de importância atribuído a outros problemas de saúde, a sua utilização por partedos médicos de cuidados primários pode ser substancialmente melhorada. Para tal, é importante insistir na necessidade de oferecer apoio e programasde formação continuada aos médicos de cuidados primários para ajudá-los neste propósito

Age differences in presentation, diagnosis pathway and management of colorectal cancer.

BACKGROUND: The gap in survival between older and younger European cancer patients is getting wider. It is possible that cancer in the elderly is being managed or treated differently than in their younger counterparts. This study aims to explore age disparities with respect to the clinical characteristics of the tumour, diagnostic pathway and treatment of colorectal cancer patients. METHODS: We conducted a multicenter cross sectional study in 5 Spanish regions. Consecutive incident cases of CRC were identified from pathology services. MEASUREMENTS: From patient interviews, hospital and primary care clinical records, we collected data on symptoms, stage, doctors investigations, time duration to diagnosis/treatment, quality of care and treatment. RESULTS: 777 symptomatic cases, 154 were older than 80 years. Stage was similar by age group. General symptoms were more frequent in the eldest and abdominal symptoms in the youngest. No differences were found regarding perception of symptom seriousness and symptom disclosure between age groups as no longer duration to diagnosis or treatment was observed in the oldest groups. In primary care, only ultrasound is more frequently ordered in those <65 years. Those >80 years had a significantly higher proportion of iron testing and abdominal XR requested in hospital. We observed a high resection rate independently of age but less adjuvant chemotherapy in Stage III colon cancer, and of radiotherapy in stage II and III rectal cancer as age increases. CONCLUSION: There are no relevant age disparities in the CRC diagnosis process with similar stage, duration to diagnosis, investigations and surgery. However, further improvements have to be made with respect to adjuvant therapy.

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.

Expectations, experiences and attitudes of patients and primary care health professionals regarding online psychotherapeutic interventions for depression: protocol for a qualitative study.

BACKGROUND: In the year 2020, depression will cause the second highest amount of disability worldwide. One quarter of the population will suffer from depression symptoms at some point in their lives. Mental health services in Western countries are overburdened. Therefore, cost-effective interventions that do not involve mental health services, such as online psychotherapy programs, have been proposed. These programs demonstrate satisfactory outcomes, but the completion rate for patients is low. Health professionals' attitudes towards this type of psychotherapy are more negative than the attitudes of depressed patients themselves. The aim of this study is to describe the profile of depressed patients who would benefit most from online psychotherapy and to identify expectations, experiences, and attitudes about online psychotherapy among both patients and health professionals that can facilitate or hinder its effects. METHODS: A parallel qualitative design will be used in a randomised controlled trial on the efficiency of online psychotherapeutic treatment for depression. Through interviews and focus groups, the experiences of treated patients, their reasons for abandoning the program, the expectations of untreated patients, and the attitudes of health professionals will be examined. Questions will be asked about training in new technologies, opinions of online psychotherapy, adjustment to therapy within the daily routine, the virtual and anonymous relationship with the therapist, the process of online communication, information necessary to make progress in therapy, process of working with the program, motivations and attitudes about treatment, expected consequences, normalisation of this type of therapy in primary care, changes in the physician-patient relationship, and resources and risks. A thematic content analysis from the grounded theory for interviews and an analysis of the discursive positions of participants based on the sociological model for focus groups will be performed. DISCUSSION: Knowledge of the expectations, experiences, and attitudes of both patients and medical personnel regarding online interventions for depression can facilitate the implementation of this new psychotherapeutic tool. This qualitative investigation will provide thorough knowledge of the perceptions, beliefs, and values of patients and clinicians, which will be very useful for understanding how to implement this intervention method for depression.

Low intensity vs. self-guided internet-delivered psychotherapy for major depression: a multicenter, controlled, randomized study.

BACKGROUND: Major depression will become the second most important cause of disability in 2020. Computerized cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy has been carried out. The aim of this study is to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system. METHODS: The study is made up of 3 phases: 1.- Development of a computerized cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed. DISCUSSION: The comparisons between low intensity and self-guided are infrequent, and also a comparative economic evaluation between them and compared with usual treatment in primary. The strength of the study is that it is a multicenter, randomized, controlled trial of low intensity and self-guided Internet-delivered psychotherapy for depression in primary care, being the treatment completely integrated in primary care setting. TRIAL REGISTRATION: Clinical Trials NCT01611818.

Adherencia a las recomendaciones sobre estilo de vida en pacientes con depresión / Adherence to lifestyle recommendations by patients with depression

Introducción. La práctica de ejercicio físico y la exposición a la luz solar cada vez tiene mayor respaldo experimental sobre su eficacia antidepresiva coadyuvante en pacientes con depresión leve o moderada. Sin embargo, no hay información objetiva disponible sobre el grado de adherencia que los pacientes depresivos son capaces de desarrollar frente a estas recomendaciones en condiciones de práctica habitual, lo que limita la tendencia del clínico a prescribirlas. Métodos. Se estudia una muestra de 15 pacientes con un episodio depresivo de más de un mes de evolución con tratamiento antidepresivo a los que se les colocó un actígrafo en forma de reloj de pulsera capaz de medir la actividad física y la exposición a la luz durante las 24 horas del día. Una semana después de la evaluación basal estos pacientes fueron aleatorizados en 2 grupos. En el primero de ellos se les pedía en una breve nota por escrito de forma explícita y concreta que aumentaran la actividad física y la exposición a la luz solar, mientras que en el segundo grupo no. Resultados. En la semana posterior a la entrega de las recomendaciones, solo el primer grupo aumentó su actividad física y su exposición a la luz (14,3 y 25,8% respectivamente). Conclusión. Los pacientes con depresión muestran un buen nivel de adherencia a recomendaciones sobre su estilo de vida a corto plazo(AU)

Introduction. There is an increasing amount of evidence showing that physical activity and sun exposure are effective coadjuvant treatments for patients with mild to moderate depression. However, there is a lack of information regarding patient's adherence to these recommendations in daily clinical practice. Methods. We conducted a study including 15 depressive patients who had been under antidepressant treatment for at least one month. They wore a wrist-watch-like actimetry sensor to measure physical activity and sun exposure 24h a day. After one week of baseline assessment, patients were randomized into one of the two arms of the study. Patients in the experimental group received a brief note in which they were explicitly asked to increase both their physical activity level and time of sun exposure, while control group patients did not receive these explicit recommendations. Results. One week after recommendations were delivered, only patients in the experimental group had increased time of sun exposure and physical activity (25.8% and 14.3%, respectively). Conclusions. Depressive patients are able to follow prescribed lifestyle recommendations in the short-term(AU)

Hygienic-dietary recommendations for major depression treatment: study protocol of a randomized controlled trial.

BACKGROUND: Depression is a highly prevalent and disabling mental disorder with an incidence rate which appears to be increasing in the developed world. This fact seems to be at least partially related to lifestyle factors. Some hygienic-dietary measures have shown their efficacy as a coadjuvant of standard treatment. However, their effectiveness has not yet been proved enough in usual clinical practice. METHODS: Multicenter, randomized, controlled, two arm-parallel, clinical trial involving 300 patients over 18 years old with a diagnosis of Major Depression. Major depression will be diagnosed by means of the Mini-International Neuropsychiatric Interview. The Beck Depression Inventory total score at the end of the study will constitute the main efficacy outcome. Quality of Life and Social and Health Care Services Consumption Scales will be also administered. Patients will be assessed at three different occasions: baseline, 6-month follow-up and 12-month follow-up. DISCUSSION: We expect the patients in the active lifestyle recommendations group to experience a greater improvement in their depressive symptoms and quality of life with lower socio-sanitary costs. TRIAL REGISTRATION: ISRCTN73931675.

Adherence to lifestyle recommendations by patients with depression.

INTRODUCTION: There is an increasing amount of evidence showing that physical activity and sun exposure are effective coadjuvant treatments for patients with mild to moderate depression. However, there is a lack of information regarding patient's adherence to these recommendations in daily clinical practice. METHODS: We conducted a study including 15 depressive patients who had been under antidepressant treatment for at least one month. They wore a wrist-watch-like actimetry sensor to measure physical activity and sun exposure 24 hours a day. After one week of baseline assessment, patients were randomised into one of the two arms of the study. Patients in the experimental group received a brief note in which they were explicitly asked to increase both their physical activity level and time of sun exposure, while control group patients did not receive these explicit recommendations. RESULTS: One week after recommendations were delivered, only patients in the experimental group had increased time of sun exposure and physical activity (25.8% and 14.3%, respectively). CONCLUSIONS: Depressive patients are able to follow prescribed lifestyle recommendations in the short-term.

Four hygienic-dietary recommendations as add-on treatment in depression: a randomized-controlled trial.

BACKGROUND: Modifying diet, exercise, sunlight exposure and sleep patterns may be useful in the treatment of depression. METHOD: Eighty nonseasonal depressive outpatients on anti-depressant treatment were randomly assigned either to the active or control group. Four hygienic-dietary recommendations were prescribed together. Outcome measures were blinded assessed before and after the six month intervention period. RESULTS: A better evolution of depressive symptoms, a higher rate of responder and remitters and a lesser psychopharmacological prescription was found in the active group. LIMITATIONS: Small sample size. Lacked homogeneity concerning affective disorders (major depression, dysthimia, bipolar depression). CONCLUSIONS: This study suggests lifestyle recommendations can be used as an effective antidepressant complementary strategy in daily practice.

Study of the therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy: a randomised controlled trial.

BACKGROUND: Although hippotherapy treatment has been demonstrated to have therapeutic effects on children with cerebral palsy, the samples used in research studies have been very small. In the case of hippotherapy simulators, there are no studies that either recommend or advise against their use in the treatment of children with cerebral palsy. The aim of this randomised clinical study is to analyse the therapeutic effects or the contraindications of the use of a commercial hippotherapy simulator on several important factors relating to children with cerebral palsy such as their motor development, balance control in the sitting posture, hip abduction range of motion and electromyographic activity of adductor musculature. METHODS/DESIGN: The study is a randomised controlled trial. It will be carried out with a sample of 37 children with cerebral palsy divided into two treatment groups. Eligible participants will be randomly allocated to receive either (a) Treatment Group with hippotherapy simulator, maintaining sitting posture, with legs in abduction and rhythmic movement of the simulator or (b) Treatment Group maintaining sitting posture, with legs in abduction and without rhythmic movement of the simulator. DATA COLLECTION AND ANALYSIS: all measurements will be carried out by a specially trained blind assessor. To ensure standardization quality of the assessors, an inter-examiner agreement will be worked out at the start of the study. The trial is funded by the Department of Research, Innovation and Development of the Regional Government of Aragon (Official Bulletin of Aragon 23 July 2007), project number PM059/2007. DISCUSSION: Interest in this project is due to the following factors: Clinical originality (there are no previous studies analysing the effect of simulators on the population group of children with CP, nor any studies using as many variables as this project); Clinical impact (infantile cerebral palsy is a chronic multisystemic condition that affects not only the patient but also the patient's family and their close circle of friends); Practical benefits (the development of an effective treatment is very important for introducing this element into the rehabilitation of these children). TRIAL REGISTRATION: Current Controlled Trials ISRCTN03663478.

Análisis de correlación y validez predictiva de los constructos relacionados con el dolor en fibromialgia / No disponible

No disponible

Personality disorders in somatization disorder patients: a controlled study in Spain.

OBJECTIVE: The aim of this paper is to assess personality disorder (PD) comorbidity in somatization disorder (SD) patients compared with psychiatric controls in a Spanish sample. METHODS: This is a case-control study. Selection of 70 consecutive SD patients was made, and an age-, sex-, and ethnic-group-matched control group of 70 mood and/or anxiety disorder patients recruited in psychiatric outpatient clinics was selected. PDs were measured using the International Personality Disorder Examination, and Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I morbidity was measured by means of the Standardized Polyvalent Psychiatric Interview. RESULTS: PD comorbidity in SD patients was 62.9%, compared to 28.2% in controls [odds ratio (OR)=3.7; 95% confidence interval (95% CI)=1.8-7.6]. The highest ORs of PD in SD patients, compared with controls, were for paranoid (OR=9.2; 95% CI=1.9-43), obsessive-compulsive (OR=6.2; 95% CI=1.2-53.6), and histrionic (OR=3.6; 95% CI=0.9-13.9) PDs. CONCLUSIONS: This is a controlled study with the largest sample of SD patients. The prevalence of PD comorbidity is similar to that of a previously published controlled study but is different from those of the most frequent PD subtypes.