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BACKGROUND: Little information is available on the association between gender nonconformity during adolescence and subsequent mental health. While the distress related to gender nonconformity may be socially produced rather than attributed to individual-level factors, further research is needed to better understand the role of psychosocial factors in this context. METHOD: We analyzed data from the Tokyo Teen Cohort, obtained through random sampling of adolescents born between 2002 and 2004. We used inverse probability weighting to examine the association of gender nonconformity at ages 12 and 14 as a time-varying variable with subsequent mental health at age 16, while accounting for time-fixed and time-varying confounders. Furthermore, we used a weighting approach to investigate the mediating role of modifiable psychosocial factors in this association, addressing exposure-mediator and mediator-mediator interactions. RESULTS: A total of 3171 participants were analyzed. Persistent gender nonconforming behavior at ages 12 and 14 was associated with subsequent depression (ß = 2.02, 95% confidence interval [CI] 0.85 to 3.19) and psychotic experiences (ß = 0.33, 95% CI 0.14 to 0.52) at age 16. The results remained robust in sensitivity analyses. Approximately 30% of the association between gender nonconformity and depression was consistently mediated by a set of psychosocial factors, namely loneliness, bullying victimization, and relationships with mother, father, and friends. CONCLUSIONS: Persistent gender nonconformity during adolescence is associated with subsequent mental health. Psychosocial factors play a vital mediating role in this association, highlighting the essential need for social intervention and change to reduce stigmatization and ameliorate mental health challenges.
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Víctimas de Crimen , Salud Mental , Humanos , Adolescente , Estudios de Cohortes , Identidad de Género , Víctimas de Crimen/psicologíaRESUMEN
BACKGROUND: We aimed to evaluate the comparative efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I), pharmacotherapy, and their combination in the long and short terms among adults with chronic insomnia disorder. METHODS: We searched multiple databases to December 27, 2023. We included trials in hypnotic-free adults with chronic insomnia comparing at least two of CBT-I, pharmacotherapy, or their combination. We assessed the confidence in evidence using CINeMA. The primary outcome was long-term remission. Secondary outcomes included all-cause dropout and self-reported sleep continuity measures in the long term, and the same outcomes in the short term. We performed frequentist random-effects network meta-analyses (CRD42024505519). FINDINGS: We identified 13 trials including 823 randomized participants (mean age, 47.8 years; 60% women). CBT-I was more beneficial than pharmacotherapy in the long term (median duration, 24 weeks [range, 12 to 48 weeks]; remission odds ratio, 1.82 [95% confidence interval (CI), 1.15-2.87]; [certainty of evidence: high]), while there was weaker evidence of benefit of combination against pharmacotherapy (1.71 [95% CI, 0.88-3.30: moderate]) and no clear difference of CBT-I against combination (1.07 [95% CI, 0.63-1.80: moderate]). CBT-I was associated with fewer dropouts than pharmacotherapy. Short-term outcomes favored CBT-I over pharmacotherapy except total sleep time. Given the average long-term remission rate in the pharmacotherapy-initiating arms of 28%, CBT-I resulted in a long-term remission rate of 41% (95% CI, 31%-53%) and combination 40% (95% CI, 25%-56%). INTERPRETATION: The current study found that starting with CBT-I for chronic insomnia leads to better outcomes than pharmacotherapy. Combination may be better than pharmacotherapy alone, but unlikely to be worth the additional burden over CBT-I alone.
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Terapia Cognitivo-Conductual , Metaanálisis en Red , Trastornos del Inicio y del Mantenimiento del Sueño , Humanos , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Terapia Combinada , Adulto , Inducción de RemisiónRESUMEN
AIM: Patients with cancer experience various forms of psychological distress, including depressive symptoms, which can impact quality of life, elevate morbidity risk, and increase medical costs. Psychotherapy and pharmacotherapy are effective for reducing depressive symptoms among patients with cancer, but most patients prefer psychotherapy. This study aimed to develop an efficient and effective smartphone psychotherapy component to address depressive symptom. METHODS: This was a decentralized, parallel-group, multicenter, open, individually randomized, fully factorial trial. Patients aged ≥20 years with cancer were randomized by the presence/absence of three cognitive-behavioral therapy (CBT) skills (behavioral activation [BA], assertiveness training [AT], and problem-solving [PS]) on a smartphone app. All participants received psychoeducation (PE). The primary outcome was change in the patient health questionnaire-9 (PHQ-9) total score between baseline and week 8. Secondary outcomes included anxiety. RESULTS: In total, 359 participants were randomized. Primary outcome data at week 8 were obtained for 355 participants (99%). The week 8 PHQ-9 total score was significantly reduced from baseline for all participants by -1.41 points (95% confidence interval [CI] -1.89, -0.92), but between-group differences in change scores were not significant (BA: -0.04, 95% CI -0.75, 0.67; AT: -0.16, 95% CI -0.87, 0.55; PS: -0.19, 95% CI -0.90, 0.52). CONCLUSION: As the presence of any of the three intervention components did not contribute to a significant additive reduction of depressive symptoms, we cannot make evidence-based recommendations regarding the use of specific smartphone psychotherapy.
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Terapia Cognitivo-Conductual , Depresión , Neoplasias , Teléfono Inteligente , Humanos , Masculino , Femenino , Persona de Mediana Edad , Depresión/terapia , Neoplasias/complicaciones , Neoplasias/terapia , Adulto , Terapia Cognitivo-Conductual/métodos , Anciano , Psicoterapia/métodos , Evaluación de Resultado en la Atención de Salud , Aplicaciones MóvilesRESUMEN
BACKGROUND: Only a limited number of patients with major depressive disorder (MDD) respond to a first course of antidepressant medication (ADM). We investigated the feasibility of creating a baseline model to determine which of these would be among patients beginning ADM treatment in the US Veterans Health Administration (VHA). METHODS: A 2018-2020 national sample of n = 660 VHA patients receiving ADM treatment for MDD completed an extensive baseline self-report assessment near the beginning of treatment and a 3-month self-report follow-up assessment. Using baseline self-report data along with administrative and geospatial data, an ensemble machine learning method was used to develop a model for 3-month treatment response defined by the Quick Inventory of Depression Symptomatology Self-Report and a modified Sheehan Disability Scale. The model was developed in a 70% training sample and tested in the remaining 30% test sample. RESULTS: In total, 35.7% of patients responded to treatment. The prediction model had an area under the ROC curve (s.e.) of 0.66 (0.04) in the test sample. A strong gradient in probability (s.e.) of treatment response was found across three subsamples of the test sample using training sample thresholds for high [45.6% (5.5)], intermediate [34.5% (7.6)], and low [11.1% (4.9)] probabilities of response. Baseline symptom severity, comorbidity, treatment characteristics (expectations, history, and aspects of current treatment), and protective/resilience factors were the most important predictors. CONCLUSIONS: Although these results are promising, parallel models to predict response to alternative treatments based on data collected before initiating treatment would be needed for such models to help guide treatment selection.
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Trastorno Depresivo Mayor , Veteranos , Humanos , Trastorno Depresivo Mayor/tratamiento farmacológico , Depresión , Antidepresivos/uso terapéutico , Aprendizaje AutomáticoRESUMEN
When data are available from individual patients receiving either a treatment or a control intervention in a randomized trial, various statistical and machine learning methods can be used to develop models for predicting future outcomes under the two conditions, and thus to predict treatment effect at the patient level. These predictions can subsequently guide personalized treatment choices. Although several methods for validating prediction models are available, little attention has been given to measuring the performance of predictions of personalized treatment effect. In this article, we propose a range of measures that can be used to this end. We start by defining two dimensions of model accuracy for treatment effects, for a single outcome: discrimination for benefit and calibration for benefit. We then amalgamate these two dimensions into an additional concept, decision accuracy, which quantifies the model's ability to identify patients for whom the benefit from treatment exceeds a given threshold. Subsequently, we propose a series of performance measures related to these dimensions and discuss estimating procedures, focusing on randomized data. Our methods are applicable for continuous or binary outcomes, for any type of prediction model, as long as it uses baseline covariates to predict outcomes under treatment and control. We illustrate all methods using two simulated datasets and a real dataset from a trial in depression. We implement all methods in the R package predieval. Results suggest that the proposed measures can be useful in evaluating and comparing the performance of competing models in predicting individualized treatment effect.
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Modelos Estadísticos , Medicina de Precisión , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Resultado del Tratamiento , Reglas de Decisión ClínicaRESUMEN
This study examined the effectiveness of a novel information and communication technology (ICT) tool developed for external memory compensation to improve memory function in participants with brain injuries. In this 3-month randomized control study, participants with memory impairment secondary to brain injury were randomly assigned on a 1:1 basis to either intervention (the ICT tool [ARATA]) or 3-month waitlist control groups. This study's primary outcome measure was memory-related difficulties in everyday life, assessed using the Everyday Memory Checklist (EMC). Secondary outcomes included tests for memory function and psychosocial status, all of which were administered by blinded assessors. Seventy-eight participants (53 males, 25 females; mean age, 43.5 ± 12.7 [SD] years) were enrolled and 39 participants were allocated to each group (intervention and control). There was no significant difference in EMC scores between the two groups throughout the study (mean 0.26; 95% CI: -2.55-3.07; p=0.853); however, the intervention group scored significantly higher on the Rivermead Behavioural Memory and General Self-Efficacy tests compared to the control group. While the ICT tool did not improve the primary study outcome, evidence suggests that the ICT tool can improve memory functions related to activities of daily living.
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Actividades Cotidianas , Lesiones Encefálicas , Masculino , Femenino , Humanos , Adulto , Persona de Mediana Edad , Lesiones Encefálicas/complicaciones , Trastornos de la Memoria/complicaciones , Programas Informáticos , AutoeficaciaRESUMEN
Little is known about antipsychotic prescription patterns among children and adolescents in Japan, particularly in outpatient settings. We investigated the prevalence and trends of antipsychotic prescription for outpatients aged ≤ 17 years receiving a first antipsychotic prescription from 2006 to 2012 based on a large-scale dispensation dataset. Measurements included age, sex, department of diagnosis and treatment, type of prescription (monotherapy or polytherapy), antipsychotic dosage, and concomitant psychotropic drugs. Of the 10,511 patients, 65.1% were aged 13-17 years, and 52.9% were males. Second-generation antipsychotic monotherapy prescriptions increased from 53.8% in 2006 to 78.3% in 2012. Risperidone was the most frequently prescribed antipsychotic, followed by aripiprazole and olanzapine. Approximately 25.0% of patients were prescribed an initial dose less than recommended. Second-generation antipsychotic monotherapy is currently the most frequent prescription pattern among outpatients aged ≤ 17 years receiving an initial antipsychotic prescription.
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Antipsicóticos , Farmacia , Masculino , Humanos , Niño , Adolescente , Femenino , Antipsicóticos/uso terapéutico , Japón/epidemiología , Risperidona/uso terapéutico , Estudios Epidemiológicos , Prescripciones de MedicamentosRESUMEN
BACKGROUND: Although the 6-item Kessler psychological scale (K6) is a useful depression screening scale in clinical settings and epidemiological surveys, little is known about the distribution model of the K6 score in the general population. Using four major national survey datasets from the United States and Japan, we explored the mathematical pattern of the K6 distributions in the general population. METHODS: We analyzed four datasets from the National Health Interview Survey, the National Survey on Drug Use and Health, and the Behavioral Risk Factor Surveillance System in the United States, and the Comprehensive Survey of Living Conditions in Japan. We compared the goodness of fit between three models: exponential, power law, and quadratic function models. Graphical and regression analyses were employed to investigate the mathematical patterns of the K6 distributions. RESULTS: The exponential function had the best fit among the three models. The K6 distributions exhibited an exponential pattern, except for the lower end of the distribution across the four surveys. The rate parameter of the K6 distributions was similar across all surveys. CONCLUSIONS: Our results suggest that, regardless of different sample populations and methodologies, the K6 scores exhibit a common mathematical distribution in the general population. Our findings will contribute to the development of the distribution model for such a depression screening scale.
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Distrés Psicológico , Trastornos Relacionados con Sustancias , Humanos , Japón/epidemiología , Análisis de Regresión , Estrés Psicológico/epidemiología , Encuestas y Cuestionarios , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: Desire for slimness (DS) is a well-established risk factor for eating disorders among adolescents, particularly girls. It is known that exposure to traditional media such as television can increase DS. However, the association between DS and the use of new media, such as social networking sites (SNS), adjusting for relevant potential confounders, has not been examined to-date. In this study, we assessed the relationship between DS and SNS use among early adolescent girls and boys, adjusting for body mass index (BMI), time spent watching television, and Internet use. METHOD: DS, SNS use, and confounding variables were assessed using self-report questionnaires and face-to-face interviews from a cross-sectional population-based survey of 4,478 10-year-old Japanese adolescents (2,100 girls and 2,378 boys). RESULTS: After adjusting for confounding variables, SNS use was associated with increased risk of DS among girls (odds ratio [OR] = 1.93; 95% confidence interval [CI], 1.17-3.18, p = .010), but not among boys (OR = 1.07; 95% CI, 0.64-1.80, p = .786). DISCUSSION: Exposure to SNS was associated with an increased risk of DS among early adolescents, especially girls. Targeting SNS use in early adolescence seems a promising approach to prevention of DS and subsequent eating problems, particularly among girls.
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Índice de Masa Corporal , Trastornos de Alimentación y de la Ingestión de Alimentos/psicología , Red Social , Niño , Estudios de Cohortes , Estudios Transversales , Femenino , Humanos , MasculinoRESUMEN
BACKGROUND: The early repolarization pattern (ERP) in electrocardiography (ECG) has been considered as a risk for ventricular fibrillation (VF), but effective methods for identification of malignant ERP are still required. We investigated whether high spatiotemporal resolution 64-channel magnetocardiography (MCG) would enable distinction between benign and malignant ERPs. METHODS: Among all 2,636 subjects who received MCG in our facility, we identified 116 subjects (43 ± 18 years old, 54% male) with inferior and/or lateral ERP in ECG and without structural heart disease, including 13 survivors of VF (ERP-VF(+)) and 103 with no history of VF (ERP-VF(-)). We measured the following MCG parameters in a time-domain waveform of relative current magnitude: (a) QRS duration (MCG-QRSD), (b) root-mean-square of the last 40 ms (MCG-RMS40), and (c) low amplitude (<10% of maximal) signal duration (MCG-LAS). RESULTS: Compared to ERP-VF(-), ERP-VF(+) subjects presented a significantly longer MCG-QRS (108 ± 24 vs. 91 ± 23 ms, p = .02) and lower MCG-RMS40 (0.10 ± 0.08 vs. 0.25 ± 0.20, p = .01) but no difference in MCG-LAS (38 ± 22 vs. 29 ± 23 ms, p = .17). MCG-QRSD and MCG-RMS40 showed significantly larger area under the ROC curve compared to J-peak amplitude in ECG (0.72 and 0.71 vs. 0.50; p = .04 and 0.03). The sensitivity, specificity, and odds ratio for identifying VF(+) based on MCG-QRSD ≥ 100 ms and MCG-RMS40 ≤ 0.24 were 69%, 74%, and 6.33 (95% CI, 1.80-22.3), and 92%, 48%, and 10.9 (95% CI, 1.37-86.8), respectively. CONCLUSION: Magnetocardiography is an effective tool to distinguish malignant and benign ERPs.
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Magnetocardiografía/métodos , Fibrilación Ventricular/diagnóstico , Fibrilación Ventricular/fisiopatología , Adulto , Femenino , Humanos , MasculinoRESUMEN
BACKGROUND: Overactive bladder (OAB) symptoms affect daily life by decreasing health-related quality of life (HRQol). However, there remain no very effective treatment for OAB. Pharmacotherapy is one of the best treatments, but it is not always efficient and may incur adverse events. Although behavioral therapy is another effective treatment, there are very few structured treatment manuals on how to prescribe behavioral therapy to treat OAB for whom. Cognitive behavioral therapy (CBT) is a psychotherapy consisting of structured sessions to solve problems with the collaborative empiricism between therapists and patients. OAB symptoms are supposed to worsen with cognitive distortion, and CBT is expected to be effective in treating OAB by modifying such cognitive processes. In this trial, we will evaluate the efficacy of CBT for OAB. METHODS: A randomized, controlled, open-label, multicenter parallel-group superiority trial will be conducted. Participants with moderate to severe OAB symptoms with or without pharmacotherapy will be recruited and will be randomly allocated 1:1 to two different groups by minimization (age, baseline OAB severity, treatment status, types of intervention, and treating institutions). The intervention group will be prescribed an individual CBT program covering six techniques in 4 sessions (30 min each), with or without pharmacotherapy. The primary outcome is the change scores in an OAB-questionnaire (OAB-q) from baseline to the end of the trial (week 13). Secondary outcomes will include other patient reported outcome measures and the frequency volume chart. All analyses will be conducted on an intention-to-treat principle. DISCUSSION: This trial will determine the efficacy of CBT to treat OAB using a rigorous methodology. The effectiveness of CBT with a structured manual may not only lead to a new treatment option for patients suffering from OAB symptoms, but may also reduce the social burden by OAB. TRIAL REGISTRATION: UMIN-CTR Clinical Trial, CTR-UMIN000038513 . Registered on November 7, 2019.
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Terapia Cognitivo-Conductual , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Vejiga Urinaria Hiperactiva/terapia , Femenino , Humanos , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: Recently, item responses and total scores on depression screening scales have been reported to have characteristic distributions in the general population. The distributional pattern of responses to the Patient Health Questionnaire-9 (PHQ-9) in the general population has not been well studied. Thus, we carried out a pattern analysis of the PHQ-9 item responses and total scores in US adults. METHODS: Data (5372 individuals) were drawn from the 2013-2014 National Health and Nutrition Examination Survey in the United States. The item responses and total score distributions of the PHQ-9 data were investigated with graphical analysis and exponential regression model. RESULTS: Lines of item responses showed the same pattern among the nine items, characterized by crossing at a single point between "not at all" and "several days" and a parallel pattern from "several days" to "nearly every day" on a log-normal scale. The total score distribution of the PHQ-9 exhibited an exponential pattern, except for at the lower end of the distribution. CONCLUSIONS: The present results support that the item responses and total scores on the PHQ-9 in the general population show the same characteristic patterns, consistent with the previous studies using the Center for Epidemiologic Studies Depression Scale (CES-D) and Kessler Screening Scale for Psychological Distress (K6).
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Depresión/epidemiología , Encuestas Nutricionales , Cuestionario de Salud del Paciente/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Modelos Lineales , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Estados Unidos/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Major depressive disorder (MDD) is a common and often chronic problem. Patients with chronic MDD often have negative impacts on the health of their families. Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder, and has been shown to reduce the rate of relapse in individuals with schizophrenia and to reduce the burden on their caregivers. Thus, we predict that family psychoeducation has the potential to reduce the burden on the caregivers of patients with chronic MDD. In the present study, we aimed to investigate the effects of brief multifamily psychoeducation (BMP) on the mental health status of family members of patients with chronic MDD. METHODS: We conducted a clinical trial consisting of 49 chronic MDD patients and their families. Each family was randomly assigned to either the BMP intervention group or the control group. The intervention group received four BMP sessions, once every two weeks for eight weeks. The control group received one counseling session administered by a nurse. All patients received standard treatment administered by physicians. The primary outcome measurement was the Kessler Screening Scale for Psychological Distress (K6) score of family members at 16- weeks after the first BMP session. Secondary outcomes were depressive symptoms of both family members and patients at multiple time points, as well as family functioning as evaluated by the patients. Intention-to-treat analyses were conducted. RESULTS: There was no statistically significant effect of BMP on K6 scores at 16- weeks (mean difference 1.17, 95% confidence interval: - 0.63 to 2.98, P = 0.19). Exploratory analyses revealed that BMP reduced depressive symptoms in family members at 8- weeks (difference = - 3.37, 95%CI -6.32 to - 0.43, P = 0.02) and improved family functioning at multiple time points (Role; 8 W, difference = - 0.13, 95%CI -0.26 to - 0.00, P = 0.04, Affective Responsiveness; 8 W, difference = - 0.24, 95%CI -0.43 to - 0.05, P = 0.01, 32 W, difference = - 0.22, 95%CI -0.41 to - 0.03, P = 0.02, Behavior Control; 16 W, difference = - 0.17, 95%CI -0.34 to - 0.00, P = 0.04). CONCLUSIONS: Four BMP sessions did not significantly reduce the psychological distress of family members of patients with chronic MDD. TRIAL REGISTRATION: Clinical Trials. gov NCT01734291 , retrospectively registered (Registration date: November 21, 2012).
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Trastorno Depresivo Mayor/terapia , Psicoterapia Breve/métodos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Cuidadores , Enfermedad Crónica , Familia , Femenino , Educación en Salud , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Estudios Retrospectivos , Esquizofrenia/terapia , Adulto JovenRESUMEN
INTRODUCTION: Bullying among adolescents can cause depression and suicidality. Identifying the risk factors for bullying in early adolescence, when its prevalence tends to increase, would assist in its prevention. Although certain parenting styles are known to be associated with bullying, the association of slapping as a parental disciplinary practice with early adolescent bullying is not sufficiently understood. Furthermore, little is known about how warm parenting modifies this association although slapping and warm parenting are not mutually exclusive. The aim of this study was to investigate the association of slapping with the experience of early adolescent bullying--categorized in terms of victims, bullies, and bully-victims--while considering how warm parenting modifies this association. METHODS: This study used data from the Tokyo Early Adolescence Survey, a cross-sectional survey of 4478 children aged 10 from the general population. Data were collected from both children and their primary parent using self-administered questionnaires and face-to-face interviews. Responses from 4326 participants with no missing data were usable for the current analysis (mean age,â¯â¯10.2⯱â¯0.3 years; 53 % boys). RESULTS: Frequent and occasional slapping was associated with increased odds of youth being identified as bullies or bully-victims, even after adjusting for warm parenting. The likelihood of being victims, bullies or bully-victims increased as the frequency of slapping increased. CONCLUSION: Disciplinary slapping was associated with increased odds of bullying in early adolescence, regardless of whether warm parenting was present or not.
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Acoso Escolar/psicología , Responsabilidad Parental/psicología , Castigo/psicología , Niño , Estudios Transversales , Femenino , Humanos , Masculino , Factores de Riesgo , Encuestas y CuestionariosRESUMEN
BACKGROUND: The distributional pattern of total scores on depression screening scales in the general population has not been well studied. Recent studies suggest that the total scores on depression screening scales follow an exponential pattern, with the exception of the lower end of the distribution. To further investigate the findings, we determined the distributions of the total and individual item scores on the Kessler Screening Scale for Psychological Distress (K6). METHODS: Data were obtained from the National Survey of Midlife Development in the United States. Participants comprised 6,223 individuals between the ages of 25 and 74. The distributions of the total and individual item scores in various combinations were investigated with histograms and regression analysis. RESULTS: Irrespective of the combination of items, the total and individual item scores followed an exponential pattern except at the lower scores. The estimated rate parameters of regression analysis were similar among distributions with the same number of chosen items. At the lower scores, the distributional patterns of total scores varied according to the ratio of "a little" to "none" for each item response. CONCLUSIONS: The present results have the potential to estimate the distribution of depressive symptoms in the general population. While the degree of depressive symptoms varies from individual to individual, an entire population may show a certain mathematical distribution.
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Depresión/diagnóstico , Escalas de Valoración Psiquiátrica/estadística & datos numéricos , Distribuciones Estadísticas , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Análisis de Regresión , Estados UnidosRESUMEN
BACKGROUND: Choto-san is a traditional medicine used for hypertension and headaches in Japan and China. Some studies have shown its effectiveness in the treatment of dementia. The present review aimed to assess the effectiveness and acceptability of Choto-san in the treatment of adults with cognitive impairment. METHODS: We included randomized controlled trials comparing Choto-san with placebo for patients with dementia or mild cognitive impairment. RESULTS: Three randomized controlled trials evaluating 219 participants were included. Two were studies on vascular dementia, and the other was on Alzheimer's dementia. There was no difference between Choto-san and placebo in terms of short-term dichotomous judgement of improvement, but Choto-san was more effective than placebo in terms of short-term improvement of cognitive function as measured by continuous outcomes. Also, dropouts judged it to be acceptable. However, the results were imprecise and/or heterogeneous. The number of participants included in the analysis was small (n = 199 in the primary analysis) and sometimes inconsistent, as indicated by the large I 2 (72% in the primary analysis). CONCLUSION: Low-quality evidence was suggestive of Choto-san's efficacy for vascular dementia, but the present results may be overestimated. Studies with a larger sample size and conducted over longer periods should be performed. Regardless, Choto-san can be one of the choices for the treatment of vascular dementia as it is well tolerated.
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Trastornos del Conocimiento/tratamiento farmacológico , Demencia/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Placebos/uso terapéutico , Demencia/metabolismo , Humanos , Extractos Vegetales , Plantas Medicinales , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
AIM: Although the efficacy of cognitive behavioral therapy for insomnia has been confirmed, dissemination depends on the balance of benefits and costs. This study aimed to examine the cost-effectiveness of cognitive behavioral therapy for insomnia consisting of four weekly individual sessions. METHODS: We conducted a 4-week randomized controlled trial with a 4-week follow up in outpatient clinics in Japan. Thirty-seven patients diagnosed as having major depressive disorder according to DSM-IV and suffering from chronic insomnia were randomized to receive either treatment as usual (TAU) alone or TAU plus cognitive behavioral therapy for insomnia. Effectiveness was evaluated as quality-adjusted life years (QALY) over 8 weeks' time, estimated by bootstrapping of the observed total scores of the Hamilton Depression Rating Scale. Direct medical costs for cognitive behavioral therapy for insomnia and TAU were also evaluated. We calculated the incremental cost-effectiveness ratio. RESULTS: Over the 8 weeks of the study, the group receiving cognitive behavioral therapy for insomnia plus TAU had significantly higher QALY (P = 0.002) than the TAU-alone group with an incremental value of 0.019 (SD 0.006), and had non-significantly higher costs with an incremental value of 254 (SD 203) USD in direct costs. The incremental cost-effectiveness ratio was 13 678 USD (95% confidence interval: -5691 to 71 316). Adding cognitive behavioral therapy for insomnia demonstrated an approximately 95% chance of gaining one more QALY if a decision-maker was willing to pay 60 000 USD, and approximately 90% for 40 000 USD. CONCLUSION: Adding cognitive behavioral therapy for insomnia is highly likely to be cost-effective for patients with residual insomnia and concomitant depression.
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Terapia Cognitivo-Conductual/economía , Trastorno Depresivo Mayor/terapia , Trastorno Depresivo Resistente al Tratamiento/terapia , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Adulto , Antidepresivos/uso terapéutico , Terapia Cognitivo-Conductual/métodos , Comorbilidad , Análisis Costo-Beneficio , Trastorno Depresivo Mayor/economía , Trastorno Depresivo Mayor/epidemiología , Trastorno Depresivo Resistente al Tratamiento/economía , Trastorno Depresivo Resistente al Tratamiento/epidemiología , Femenino , Humanos , Japón , Masculino , Persona de Mediana Edad , Años de Vida Ajustados por Calidad de Vida , Trastornos del Inicio y del Mantenimiento del Sueño/economía , Trastornos del Inicio y del Mantenimiento del Sueño/epidemiología , Resultado del TratamientoRESUMEN
BACKGROUND: To examine empirically whether the mean difference (MD) or the standardised mean difference (SMD) is more generalizable and statistically powerful in meta-analyses of continuous outcomes when the same unit is used. METHODS: From all the Cochrane Database (March 2013), we identified systematic reviews that combined 3 or more randomised controlled trials (RCT) using the same continuous outcome. Generalizability was assessed using the I-squared (I2) and the percentage agreement. The percentage agreement was calculated by comparing the MD or SMD of each RCT with the corresponding MD or SMD from the meta-analysis of all the other RCTs. The statistical power was estimated using Z-scores. Meta-analyses were conducted using both random-effects and fixed-effect models. RESULTS: 1068 meta-analyses were included. The I2 index was significantly smaller for the SMD than for the MD (P < 0.0001, sign test). For continuous outcomes, the current Cochrane reviews pooled some extremely heterogeneous results. When all these or less heterogeneous subsets of the reviews were examined, the SMD always showed a greater percentage agreement than the MD. When the I2 index was less than 30%, the percentage agreement was 55.3% for MD and 59.8% for SMD in the random-effects model and 53.0% and 59.8%, respectively, in the fixed effect model (both P < 0.0001, sign test). Although the Z-scores were larger for MD than for SMD, there were no differences in the percentage of statistical significance between MD and SMD in either model. CONCLUSIONS: The SMD was more generalizable than the MD. The MD had a greater statistical power than the SMD but did not result in material differences.
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Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Interpretación Estadística de Datos , Humanos , Distribución AleatoriaRESUMEN
Auditory hallucinations and delusions are core symptoms of schizophrenia, which interact with each other. The attribution of auditory hallucinations to other people is considered to lead to secondary delusions. This study examined whether brief psychoeducation can change the cognition of auditory hallucinations, particularly, their attribution, and thus alleviate secondary delusions. Twenty-two schizophrenic patients with auditory hallucinations were recruited in this open study. The intervention consisted of five sessions during the course of 4 weeks. Outcome measures were used to assess delusions, beliefs about auditory hallucinations, and depression. At the end of the intervention, statistically significant reduction was observed in both delusions and depression. Beliefs about hallucinations showed statistically significant improvement in terms of malevolence, omnipotence, and resistance but not in terms of benevolence and engagement. In conclusion, the present study suggests that psychoeducation might be useful in reducing secondary delusions without exacerbating a depressive state.