Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

BACKGROUND: Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services.Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. METHODS/DESIGN: This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. DISCUSSION: This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov, number NCT01484223 [http://ClinicalTrials.gov].S

Cardiac Rehabilitation in Primary Care. Impact of an Intervention on Perceived Self-Efficacy

Cardiac rehabilitation is cost-effective and should be considered a part of the care system provided to patients who have suffered a myocardial infarction or another heart disease. The main variable to study was the scoring, prior to and after the intervention in the General Scale of Self-Efficacy by Baessler & Schwarzer. A clinical community trial that was open controlled and randomised was used. All adult subjects of both sexes who had completed a cardiac rehabilitation program for 12 months at the reference hospital were selected and offered to participate. The psychometric variables registered were the Salamanca screening questionnaire, the Hamilton Anxiety Rating Scale, and the Beck Depression Inventory. Eighty-nine subjects accepted to participate in the study (93.89% response rate), with an average age of 63.01 years (SD 8.75). Once the study was concluded, the main outcome was a difference in means of 6.09 points in the General Scale of Self-Efficacy (p < 0.0053, 96% confidence interval—4.1950–10.29), showing that the group exposed to the intervention reached a higher score in the above-mentioned scale. However, there were no significant differences (t-student 0.1211; p = 0.943) after the estimation and contrast of population means for score differences between the groups regarding the Hamilton scale. Similarly, there were no significant differences between the groups regarding the means obtained in the variable score difference in the Beck Depression Inventory (t-student −0.1281; p = 0.8987). The results showed an increase in those scores related to general self-efficacy among the population that completed the intervention program, as compared to the control group

Perceived self-efficacy in patients after a cardiac rehabilitation programme in primary care: A new model of attention.

Fundamentos: La literatura evidencia la posibilidad de intervención, desde la prevención primaria hasta la rehabilitación tras un evento cardiaco, y así disminuir su incidencia y facilitar la reincorporación a la vida cotidiana. El objetivo de este trabajo fue determinar el efecto sobre la autoeficacia percibida de una intervención en rehabilitación cardiaca a pacientes que han sufrido evento cardíaco. Métodos: Se diseñó un ensayo comunitario abierto, controlado y aleatorizado, realizado en atención primaria de salud. Para determinar el tamaño de muestra, el equipo de investigación utilizó la Escala General de Autoeficacia de Baessler y Schwarzer. La diferencia de medias entre grupos considerada como clínicamente relevante fue de al menos 6 puntos en la puntuación de la Escala General de Autoeficacia. Se aceptó una precisión del 95% y un poder del test del 80%. El resultado propuso una muestra de 44 sujetos en cada grupo. Se propuso participar, a lo largo de 12 meses, a todos los sujetos, mayores de edad (N=104), de ambos sexos, que concluyeron la fase II en la unidad de RHC del Hospital Universitario Puerta del Mar (Cádiz). Se informó a los pacientes de la realización del estudio pidiéndoles su participación y ofreciendo consentimiento informado por escrito. De forma aleatoria, los sujetos fueron asignados aleatoriamente, siendo esta asignación de forma ciega (en sobre cerrado al investigador), al grupo de intervención o de control, mediante una proporción preestablecida 2:1 (dos pacientes a asignados a grupo intervención por uno a grupo control. Se realizó un registro de la no respuesta o rechazo a participar en el estudio para el análisis de la no respuesta. Resultados: Un total de 89 sujetos fueron incluidos en el análisis estadístico (tasa de respuesta de 85,57%), con una edad media de 63,01 años, (DE: 8,75). La variable dependiente principal fue la diferencia de puntuación entre grupos, comparando medias, antes y después de la intervención, en la escala general de autoeficacia de Baessler & Schwarner. Se obtuvo diferencia de medias de 6,0972 puntos entre los grupos de intervención y de control (p<0.0053, IC 95% -4,1950 a -10,29), resultado de un aumento de 3,3750 puntos de media en el grupo de intervención (desviación estándar 7,01), y un descenso de 2,7222 puntos de media (desviación estándar 7,19), en el grupo de control. En relación a los posibles cambios a detectar en las escalas de ansiedad de Hamilton e inventario de depresión de Beck, tras finalizar la intervención, se realizó una estimación y contraste de medias poblacionales entre grupos para la diferencia de puntuaciones en la escala de Hamilton, determinadas en la visita final, no encontrándose diferencias significativas (t student 0,1211; p<0,9 43). De igual forma, no se encontraron diferencias significativas entre grupos para las medias obtenidas en la variable “diferencia de puntuación en inventario de Beck en depresión” (t student -0,1281; p < 0,8987). Conclusiones: La inclusión en los programas de rehabilitación cardiaca realizados en atención primaria mejora la autoeficacia general percibida de pacientes que han sufrido eventos cardíacos.Background: The literature points to the possibility of carrying out an intervention, from primary prevention to rehabilitation after a cardiac event, towards decreasing the incidence of such cardiac events and facilitating the return to daily life. The objective was to determine the effect of a cardiac rehabilitation intervention over perceived selfefficacy for patients who have suffered a cardiac event. Methods: A community clinical trial, open, controlled, and randomised, was designed, and performed in primary care. To determine the sample size, the research team used the General Self-Efficacy Scale by Baessler and Schwarzer. The mean difference between groups considered of clinical relevance was of at least 6 points in the aforementioned General Self-Efficacy Scale. A precision of 95% and a test power of 80% were accepted. The result proposed a sample of 44 subjects in each group. Over 12 months, all subjects of legal age (N=104), both sexes, that had concluded phase II in the cardiac rehabilitation unit of the University Hospital Puerta del Mar (Cadiz) were offered to participate in the study. The patients were informed about the study development, asking for their participation and providing them with a written informed consent. The subjects were randomly assigned to the intervention or control group through blind allocation (in a sealed envelope to the researcher), on a preset 2:1 ratio (two patients assigned to the intervention group to one assigned to the control group). A non-response or rejection to participate in the study record was made for the non-response analysis. Results: A total of 89 subjects were included in the statistical analysis (response rate of 85.57%), with an average age of 63.01 years (SD: 8.75). The main dependent variable was the scores difference between groups, comparing means before and after the intervention, through the General Self-Efficacy Scale by Baessler & Schwarner. A mean difference of 6.0972 points was obtained between the intervention and the control groups (p<0.0053; 95% CI -4.1950 to -10.29), as a result of a 3.3750 mean points increase (standard deviation: 7.01) in the intervention group and a 3.3750 mean points decrease (standard deviation: 7.19) in the control group. In relation to the possible changes to be detected through the Hamilton anxiety scale and the Beck’s depression inventory, after finishing the intervention, an estimate and contrast of population means was made between groups for the scores difference in the Hamilton scale, determined on the final visit, with no significant differences found (t-student 0.1211; p<0.9 43). Similarly, no significant differences were found between the groups for the means obtained in the variable “Beck’s depression inventory scores difference” (t-student -0.1281; p<0.8987). Conclusions: The inclusion in cardiac rehabilitation programmes carried out in primary care improves the general perceived self-efficacy of patients who have suffered cardiac events

Evaluation of Nutritional Interventions in the Care Plan for Cancer Patients: The NOA Project

The NOA (Oncological Nutrition in Andalusia) project analyses the degree of integration and areas of improvement in implementing nutritional support in the care plans of cancer patients in Andalusia. The aim was to analyse nutritional interventions for better care of cancer patients and for the improvement of the management of malnutrition in cancer. A prospective evaluation of the implementation of two areas of improvement in nutrition was conducted in three hospitals. Data were collected from each hospital over a six-month period using an online platform. A standardised care plan was designed for hospitals in Andalusia, in which proposed improvements were devised and prioritised, selecting nutritional screening in oncology services and the participation of the Nutrition Support Team (NST) on the tumour boards, as well as the assessment of the patients presented at these sessions. Our results indicated an increase in the number of medical records with nutritional evaluation results six months later, regardless of the type of tumour or hospitalisation; and there was greater participation of the NST on the tumour boards, mainly for head and neck and oesophagogastric cases. Solutions for improvement have been pinpointed and implemented that have positively impacted the nutritional care plan in the course of oncological disease

Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

Abstract Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations. Trial registration The trial was registered with ClinicalTrials.gov, number NCT01484223 [http://ClinicalTrials.gov].</p