ensayo controlado aleatorizado

ensayo controlo aleatorizado
  • 文章类型: Clinical Trial Protocol
    背景:在中国,精神卫生服务目前无法满足有长期悲伤障碍(PGD)症状的丧亲者的需求。基于互联网的悲伤干预可能有助于填补这一空白,但此类项目尚未在中国开发或评估。拟议的研究旨在调查有效性,可接受性,以及一项名为“治愈悲伤”的在线自助干预计划的可行性,并探索潜在改善的心理机制。方法:我们设计了一项双臂随机对照试验。至少有128名参与者将被随机分配到基于Internet的干预组或等待列表控制组。基于互联网的干预将基于双重过程模型进行开发,整合心理教育技术,行为激活,认知重估,意味着重建,并将通过表达性写作传递。干预包括六个模块,每个模块中有两个会话,并要求参与者每周完成两次会议,并在6周内完成干预。主要结果包括有效性,可接受性,和可行性。有效性将通过长期悲伤的措施来评估,创伤后应激,焦虑,和抑郁症状。可接受性和可行性将通过对用户体验特征的调查和访谈来评估。次要结果包括主持人和调解人,如双重过程应对,哀思,正念,和持续的债券,探讨潜在改善的心理机制。评估将在干预前进行,干预后,和3个月的随访。结论:拟议的研究将确定有效性,可接受性,以及新开发的在线自助干预措施对长期悲伤的丧亲中国人的可行性,并阐明干预措施如何帮助症状改善。这种干预可能在缓解中国丧亲心理服务的提供和接收之间的不平衡方面发挥重要作用。
    在中国,失去亲人的人无法广泛获得精神卫生服务。这项拟议的研究将是第一个开发和评估基于互联网的自助悲伤干预措施的研究,该措施适用于长期悲伤的丧亲中国人。拟议的研究将确定干预措施是否以及如何帮助改善长期悲伤的丧亲中国人的心理健康。
    Background: In China, mental health services do not currently meet the needs of bereaved people with symptoms of prolonged grief disorder (PGD). Internet-based grief interventions may help fill this gap, but such programmes have not yet been developed or evaluated in China. The proposed study aims to investigate the effectiveness, acceptability, and feasibility of an online self-help intervention programme named Healing Grief for bereaved Chinese with prolonged grief, and to explore the psychological mechanisms of potential improvements.Methods: We designed a two-arm randomised controlled trial. At least 128 participants will be randomly assigned to either an Internet-based intervention group or a waitlist-control group. The Internet-based intervention will be developed based on the dual process model, integrating techniques of psychoeducation, behavioural activation, cognitive reappraisal, and meaning reconstruction, and will be delivered via expressive writing. The intervention comprises six modules, with two sessions in each module, and requires participants to complete two sessions per week and complete the intervention in 6 weeks. The primary outcomes include effectiveness, acceptability, and feasibility. The effectiveness will be assessed by measures of prolonged grief, posttraumatic stress, anxiety, and depressive symptoms. Acceptability and feasibility will be evaluated using survey and interview on user experience characteristics. Secondary outcomes include moderators and mediators, such as dual process coping, grief rumination, mindfulness, and continuing bond, to explore the psychological mechanisms of potential improvement. Assessments will take place at pre-intervention, post-intervention, and 3-month follow-up.Conclusion: The proposed study will determine the effectiveness, acceptability, and feasibility of the newly developed online self-help intervention for bereaved Chinese with prolonged grief and clarify how the intervention helps with symptom improvements. Such an intervention may play an important role in easing the imbalance between the delivery and receipt of bereavement psychological services in China.
    In China, mental health services are not widely available for bereaved people.The proposed study will be the first one to develop and evaluate an Internet-based self-help grief intervention for bereaved Chinese with prolonged grief.The proposed study will determine whether and how the intervention helps to improve the mental health of bereaved Chinese with prolonged grief.
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  • 文章类型: Journal Article
    背景:重症COVID-19幸存者有发生重症监护后综合征(PICS)和慢性ICU相关疼痛(CIRP)的风险。我们确定了特定的护理计划是否可以改善COVID-19疾病后有发生PICS和CIRP风险的患者的生活质量(QoL)。
    方法:PAIN-COVID试验为平行组,单中心,单盲,随机对照试验。干预包括一个后续计划,关于PICS和疼痛的患者教育,并对基线访视时医院焦虑抑郁量表(HADS)评分异常(>=8)的患者进行基于Rehm自我对照模型的心理干预。QoL用5级EQ5D(EQ5D5L)进行评估,HADS的情绪障碍,创伤后应激障碍(PTSD)与PCL-5清单,用简短的疼痛清单表格和疼痛,DouleurNeuropathique4问卷,和疼痛灾难量表。主要结果是确定基线访视后6个月的EQ视觉模拟量表(VAS)是否优于护理标准。次要结果是3个月时的EQVAS,和EQ指数,CIRP的发生率和特征,和焦虑,抑郁症,以及基线访视后3个月和6个月的PTSD。
    结论:通过EQVAS测量,该计划在改善重症COVID-19幸存者的生活质量方面并不优于标准护理。然而,我们的数据有助于为该人群的PICS和CIRP的研究和管理建立更好的策略.
    背景:#NCT04394169,于2020年5月19日注册。
    BACKGROUND: Critical COVID-19 survivors are at risk of developing Post-intensive Care Syndrome (PICS) and Chronic ICU-Related Pain (CIRP). We determined whether a specific care program improves the quality of life (QoL) of patients at risk of developing PICS and CIRP after COVID-19.
    METHODS: The PAIN-COVID trial was a parallel-group, single-centre, single-blinded, randomized controlled trial. The intervention consisted of a follow up program, patient education on PICS and pain, and a psychological intervention based on Rehm\'s self-control model in patients with abnormal depression scores (≥8) in the Hospital Anxiety and Depression Scale (HADS) at the baseline visit. QoL was evaluated with the 5-level EQ 5D (EQ 5D 5 L), mood disorders with the HADS, post-traumatic stress disorder (PTSD) with the PCL-5 checklist, and pain with the Brief Pain Inventory short form, the Douleur Neuropathique 4 questionnaire, and the Pain Catastrophizing Scale. The primary outcome was to determine if the program was superior to standard-of-care on the EQ visual analogue scale (VAS) at 6 months after the baseline visit. The secondary outcomes were EQ VAS at 3 months, and EQ index, CIRP incidence and characteristics, and anxiety, depression, and PTSD at 3 and 6 months after baseline visits.
    CONCLUSIONS: This program was not superior to standard care in improving QoL in critical COVID-19 survivors as measured by the EQ VAS. However, our data can help establish better strategies for the study and management of PICS and CIRP in this population.
    BACKGROUND: # NCT04394169, registered on 5/19/2020.
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  • 文章类型: Systematic Review
    机器人辅助治疗是一种相对较新的干预措施,越来越多的应用于脑卒中患者的康复治疗。它允许在特定任务运动的执行中增加重复次数。对于这篇评论,2021年8月至10月在PubMed进行了一次搜索,WebofScience,Scopus,科克伦,PEDro和OTseeker数据库,选择在卒中康复中使用机器人辅助手疗法的6项随机对照试验.研究一致认为,机器人辅助手部治疗在中风康复的所有阶段都有好处,这些阶段转化为上肢的运动和功能改善以及半周忽视的改善。
    Robot-assisted therapy is a relatively new intervention, increasingly used in the rehabilitation treatment of stroke patients. It allows to increase the number of repetitions in the performance of specific tasks movements. For this review, a search was carried out between August and October 2021 in the PubMed, Web of Science, Scopus, Cochrane, PEDro and OTseeker databases, selecting a total of six randomized controlled trials where robot-assisted hand therapy was used in stroke rehabilitation. Studies agree that robot-assisted hand therapy has benefits in all phases of stroke rehabilitation that translate into motor and functional improvements of the upper limb and improvements in hemispatial neglect.
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  • 文章类型: Journal Article
    The objective of this study was to examine differences in parenting, psychological well-being, and economic outcomes between fathers receiving two different programs offered by Fathers & Families Support Center for economically disadvantaged fathers: (a) Family Formation (FF), a 6-week/240-h program focused on economic stability/mobility, responsible fatherhood, and healthy relationships, with case management and legal services; (b) Economic Stability (ES), a 4-week/80-h program focused only on economic stability with limited case management and legal services. A randomized controlled trial (RCT) was used to compare fathers in FF (n = 350) vs. ES (n = 342). Surveys were administered at enrollment and 3- and 12-months postintervention. Linear and generalized linear mixed models were used to assess changes in program outcomes over time and across study groups. Four hundred and eighty-two fathers responded to either follow-up survey (251 FF, 231 ES). Nearly all (98%) were non-white (93% Black, 5% other/mixed race) and were on average 34 years old. Approximately 46% attended ≥75% of program sessions (FF 48% vs. ES 44%). Both FF and ES groups experienced improvements in parenting, psychological well-being, and financial outcomes after the programs, but changes in outcomes over time did not differ significantly by program. The lack of difference in outcomes between fathers in FF and ES groups could be due to a similar core focus on employment-related curriculum for both groups. Gaining financial stability could have contributed to positive improvements in other fatherhood domains. Implications for future research and practice are discussed herein.
    El objetivo de este estudio fue analizar las diferencias en la crianza, el bienestar psicológico y los resultados económicos entre padres que recibían dos programas diferentes ofrecidos por el Centro de Apoyo a los Padres y las Familias (Fathers & Familiares Support Center) para padres desfavorecidos económicamente: (a) Formación de una Familia (Family Formation, FF), un programa de 6 semanas/240 horas centrado en la estabilidad/movilidad económica, la paternidad responsable y las relaciones saludables, con gestión de casos y servicios legales; (b) Estabilidad Económica (Economic Stability, ES), un programa de 4 semanas/80 horas centrado solamente en la estabilidad económica con poca gestión de casos y servicios legales. Se usó un ensayo controlado aleatorizado para comparar a los padres de FF (n=350) con los de ES (n=342). Se realizaron encuestas en la inscripción y a los 3 y a los 12 meses posteriores a la intervención. Se usaron modelos lineales y modelos mixtos lineales generalizados para evaluar los cambios en los resultados de los programas con el tiempo y entre los grupos de estudio. 482 padres respondieron a cada encuesta de seguimiento (251 FF, 231 ES). Casi todos (el 98 %) eran de color (el 93 % negros, el 5 % de otra raza o de raza mestiza) y tenían, en promedio, 34 años. Aproximadamente el 46 % asistió a más del 75 % de las sesiones de los programas (el 48 % de FF frente al 44 % de ES). Tanto el grupo de FF como el de ES tuvieron mejoras en la crianza, en el bienestar psicológico y en los resultados económicos después de los programas, pero los cambios en los resultados con el tiempo no variaron significativamente por programa. La falta de diferencia en los resultados entre los padres del grupo de FF y los del grupo de ES podría deberse a un enfoque principal similar en un currículo relacionado con el empleo para ambos grupos. La adquisición de estabilidad económica podría haber contribuido a mejoras positivas en otras áreas de la paternidad. Se comentan las consecuencias para la futura investigación y la práctica.
    本研究旨在研究那些接受了“父亲与家庭支持中心”为经济困难的父亲提供的两种不同计划的父亲在养育子女、心理健康和经济成果方面的差异:(a) 家庭组建(FF),一个为期6周/240小时的项目,侧重于经济稳定/流动性、负责任的父亲、健康的关系,并提供个案管理和法律服务;(b) 经济稳定(ES),一个为期4周/80小时的项目,仅侧重于经济稳定,提供有限的个案管理和法律服务。一个随机对照试验(RCT)被用来比较参加FF(n=350)和ES(n=342)的父亲。调查是在入学时和干预后3个月和12个月进行的。线性和广义线性混合模型被用来评估项目结果随时间和不同研究组的变化。482名父亲都回应了随后的调查(251名FF,231名ES)。几乎所有的人(98%)都是非白人(93%为黑人,5%为其他/混合种族),平均年龄为34岁。大约46%的人参加了≥75%的项目会议(FF 48% vs ES 44%)。FF组和ES组在项目结束后,在养育子女、心理健康和财务状况方面都有所改善,但随着时间的推移,结果的变化并没有因项目而有明显的不同。FF组和ES组的父亲在结果上没有差异,这可能是由于两组在就业相关课程上的核心重点相似。获得经济稳定可能有助于其他父亲领域的积极改善。本文讨论了对未来研究和实践的影响。.
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  • 文章类型: Journal Article
    Background: Many people with refugee backgrounds suffer from trauma-related complex social and psychological problems, and compliance with standard psychological treatment tends to be low. More culturally adaptable treatment options seem to be needed. Objective: We aimed to investigate whether the music therapy method: \'trauma-focused music and imagery\' (tr-MI), characterized by a particular focus on arousal and affect regulation, would be equally effective as the standard psychological talk therapies for ameliorating trauma symptoms in Danish refugees. Methods: A pragmatic, noninferiority, parallel, randomized controlled trial with six-month follow-up was carried out at three clinics for refugees in the public mental health services of the Psychiatry (DK). Seventy-four adults diagnosed with posttraumatic stress disorder (PTSD) were allocated to either music therapy sessions (tr-MI, N = 39) or psychological treatment as usual (TAU, N = 35). Western classical music, new age music, and music from the participants\' own national culture were used to generate inner imagery, following a phased treatment protocol. Homework entailed listening to music. The primary outcome was the measurement of trauma symptoms by the Harvard Trauma Questionnaire, section IV (HTQ-IV); secondary measures were somatoform and psychoform dissociation (DSS-20), SDQ-20), attachment (RAAS), and well-being (WHO-5). Treatment effects reflected by primary and secondary measures were estimated using linear mixed models. Results: Tr-MI was noninferior to TAU (mean difference at follow-up HTQ-IV: 0.14, CI (-0.10; 0.38), with a - 0.3 noninferiority margin). A high dropout rate of 40% occurred in the TAU group, compared to 5% in the music therapy group. Secondary measures generated small to medium effect sizes in both groups, with significant medium effect sizes for well-being and psychoform dissociation at follow-up in tr-MI. Conclusions: Tr-MI is an innovative form of psychological treatment in refugee mental health services. Trials comparing music therapy to standardized therapy are needed to substantiate the evidence base for tr-MI therapy.
    Antecedentes: Muchas personas con antecedente de condición de refugiadas sufren complejos problemas psicológicos y sociales relacionados con el trauma, y el cumplimiento con el tratamiento psicológico estándar tiende a ser bajo. Parecen ser necesarias opciones de tratamiento más culturalmente adaptadas.Objetivo: Apuntamos a investigar si el método de músico-terapia: ‘música e imaginería focalizada en el trauma’ (tr-MI), caracterizado por un enfoque particular en el nivel de alerta y regulación emocional, podría ser igualmente efectivo como las terapias psicológicas de conversación para aliviar síntomas de trauma en refugiados daneses.Métodos: Se llevó a cabo un ensayo clínico aleatorizado controlado, pragmático, de no inferioridad, paralelo, con seis meses de seguimiento en tres clínicas para refugiados en servicios públicos de salud mental de Psiquiatría en Dinamarca. Setenta y cuatro adultos diagnosticados con Trastorno de estrés postraumático (TEPT) fueron asignados a sesiones de músico-terapia (tr-MI, N = 39) o al tratamiento psicológico de costumbre (TAU, N = 35). Se utilizó música clásica occidental, música new age, y música de la propia cultura nacional de los participantes, para generar imaginería interior, siguiendo un protocolo de tratamiento por fases. La tarea implicaba escuchar música. El resultado principal fue la medición de síntomas de trauma a través del Cuestionario de Trauma de Harvard, sección IV (HTQ-IV); las mediciones secundarias fueron disociación somatomorfa y psicomorfa (DSS-20, SDQ-20), apego (RAAS), y bienestar (WHO-5). Los efectos del tratamiento reflejados por mediciones primarias y secundarias fueron estimados usando modelos lineales mixtos.Resultados: Tr-MI no fue inferior a TAU (diferencia promedio al seguimiento HTQ-IV: 0.14, IC −0.10; 0.38), con un margen de no-inferioridad de −0.3). Una alta tasa de deserción de un 40% ocurrió en el grupo TAU, comparado con un 5% en el grupo de músico-terapia. Las mediciones secundarias generaron tamaños de efecto pequeños a medianos en ambos grupos, con un tamaño del efecto mediano significativo para bienestar y disociación psicomorfa al seguimiento en tr-MI.Conclusiones: Tr-MI es una forma innovadora de tratamiento psicológico en servicios de salud mental para refugiados. Se necesitan ensayos comparando músico-terapia con terapia estandarizada para probar la base de evidencia para la terapia tr-MI.
    背景:许多具有难民背景的人遭受创伤相关的复杂社会和心理问题, 对标准心理治疗的依从性较低。似乎需要更具文化适应性的治疗选择。目的:我们旨在丹麦样本中考查音乐治疗方法:以格外注重唤起和情感调节为特点的‘聚焦创伤的音乐和影像’ (tr-MI) 是否与缓解创伤症状的标准心理谈话疗法同样有效。方法:在精神病公共心理健康服务部门 (DK) 的三家难民诊所进行了一项为期六个月的实用, 非劣效, 平行, 随机对照试验。 74名被诊断为创伤后应激障碍 (PTSD) 的成年患者被分配到音乐治疗疗程 (tr-MI, N= 39) 或常规心理治疗 (TAU, N= 35) 。遵循阶段性的治疗方案, 西方古典音乐, 新时代音乐和参与者自身民族文化的音乐被用于生成内在图像。作业是听音乐。主要结果是通过哈佛创伤量表第四节 (HTQ-IV) 测量的创伤症状。次要测量是躯体形式和心理形式解离 (DSS-20, SDQ-20), 依恋 (RAAS) 和幸福感 (WHO-5) 。主要和次要措施所反映的治疗效果使用线性混合模型评估。结果:Tr-MI不逊色于TAU (随访HTQ-IV的均值差:0.14, CI (−0.10; 0.38), 非劣效边际为-0.3。TAU组的退出率高达40%, 音乐治疗组为5%, 而次要测量在两组中均产生了小到中的效应量, 幸福感和心理形态的解离在tr-MI随访中具有显著的中等效应量。结论:Tr-MI是难民心理健康服务中一种创新的心理治疗形式。需要比较音乐疗法与标准疗法的试验以证实tr-MI疗法的证据基础。.
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  • 文章类型: Journal Article
    通过认知刺激计划长期对轻度认知障碍的老年人进行社区健康干预的有效性提供证据。
    随机对照试验(CONSORT组规范)。
    SanJoséNorte-Centro初级保健中心和LaCaridad基金会(萨拉戈萨,西班牙)。
    29名65岁以上的患者,MEC评分24-27分,完成了48个月的随访。他们被随机分为干预组(15)和对照组(14)。
    使用红色笔记本工具进行10个为期45分钟的10个疗程的干预,以进行记忆的精神激活,定位,语言,实践,gnosis,计算,感知,逻辑推理,注意力和执行功能。
    主要结果变量是MEC-35,集合检验,Barthel指数,Lawton-Brody秤,Goldberg焦虑量表和Yesavage老年抑郁量表简表。
    分析了MEC-35的主要结果变量相对于基线水平的增加。平均而言,干预组得分高于对照组:干预后3.14分,6个月后比对照组多3.76分,12个月后多2.26分。所有差异均有统计学意义。48个月后干预组比对照组多2分。干预没有提高言语流畅性,活动日常生活和情绪。
    我们的认知刺激计划似乎可以提高认知能力,在干预后用变量MEC-35测量,6、12和48个月。没有证据表明语言流畅性有改善,日常生活和情绪活动。Clinicaltrials.gov标识符:NCT03831061。
    To provide evidence about the efficacy of a community health intervention through a cognitive stimulation program at long term in older people with mild cognitive impairment.
    Randomized controlled trial (CONSORT group norms).
    San José Norte-Centro Primary Care Center and La Caridad Foundation (Zaragoza, Spain).
    Twenty-nine people over 65 years old with a 24-27 MEC score that completed 48 months follow up. They were randomized between the intervention group (15) and the control group (14).
    The intervention was applied in 10 sessions of 45min for 10 weeks using the red notebook tool for mental activation that works memory, orientation, language, praxis, gnosis, calculation, perception, logical reasoning, attention and executive functions.
    The main outcome variables were MEC-35, Set-test, Barthel index, Lawton-Brody scale, Goldberg anxiety scale and Yesavage geriatric depression scale short form.
    Increases of the main result variable over the baseline level of MEC-35 were analyzed. On average, the intervention group obtained higher scores than control: 3.14 points post intervention, 3.76 points after 6 months and 2.26 points more than control group after 12 months. All the differences were statistically significant. After 48 months the intervention group obtained 2 points more than control group. The intervention did not improve verbal fluency, activity daily living and mood.
    Our cognitive stimulation program seems to improve cognitive performance, measured with the variable MEC-35 at post intervention, 6, 12 and 48 months. There is no evidence of improvement in verbal fluency, activity daily livings and mood. Clinicaltrials.gov Identifier: NCT03831061.
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  • 文章类型: Journal Article
    This study is the first to evaluate Functional Family Therapy (FFT) in a non-Western culture. The effectiveness of FFT was examined in relation to three proximal outcomes relevant to youth offender rehabilitation: (i) mental well-being, (ii) family functioning, and (iii) probation completion. 120 youth probationers (Mage  = 16.2, SD = 1.33) were randomly assigned to receive either standard probation services-Treatment-As-Usual (TAU; n = 57)-or FFT in addition to TAU (FFT; n = 63). Data on psychometric measures of mental well-being and family functioning were obtained at (i) preprogram, (ii) postprogram, and (iii) at the end of probation. Probation completion data were obtained from casefile records. Mean mental well-being scores of the FFT group improved from pre- to post-treatment, and gains were maintained at follow-up. However, there was a nonsignificant trend for the FFT group showing higher rates of reliable change and clinical recovery on the mental well-being scale. There were no group differences in family functioning scores over time. However, there was a significant trend for the FFT group showing higher rates of reliable change and clinical recovery on the family functioning scale. Probation completion rates were 88.9% and 70.2% for the FFT and TAU groups, respectively. Youth in the FFT group were significantly more likely to complete probation successfully. The results support FFT\'s effectiveness in Singaporean youth offenders. At a broader level, the study findings support the cross-cultural effectiveness of FFT in, and transportability to, a non-Western culture.
    Este estudio es el primero en evaluar la Terapia Familiar Funcional (TFF) en una cultura no occidental. Se analizó la eficacia de la TFF en relación con tres resultados proximales relevantes para la rehabilitación de los delincuentes juveniles: (i) bienestar mental, (ii) funcionamiento familiar y (iii) término de la libertad condicional. Se distribuyeron aleatoriamente 120 jóvenes en libertad condicional (Edad Promedio = 16.2, Desviación Típica= 1.33) para recibir servicios de libertad condicional estándar-tratamiento habitual (TH; n = 57)-o TFF además del TH (TFF; n = 63). Se obtuvieron datos sobre las medidas psicométricas de bienestar mental y funcionamiento familiar en los siguientes momentos (i) antes del programa, (ii) después del programa y (iii) al final de la libertad condicional. Se obtuvieron datos del término de la libertad condicional de los expedientes judiciales. Los puntajes del bienestar mental promedio del grupo de TFF mejoraron desde antes a después del tratamiento, y se mantuvieron los avances en el seguimiento. Sin embargo, hubo una tendencia no significativa en el grupo de TFF que indicó índices más altos de cambio fiable y recuperación clínica en la escala de bienestar mental. No hubo diferencias entre los grupos en los puntajes de funcionamiento familiar en el transcurso del tiempo. Sin embargo, hubo una tendencia significativa en el grupo de TFF que indicó índices más altos de cambio fiable y recuperación clínica en la escala de funcionamiento familiar. Los índices de término de la libertad condicional fueron 88.9 % y 70.2 % en los grupos de TFF y de TH respectivamente. Los jóvenes del grupo de TFF fueron considerablemente más propensos a terminar la libertad condicional satisfactoriamente. Los resultados respaldan la eficacia de la TFF entre los delincuentes juveniles singapurenses. A nivel general, los resultados del estudio respaldan la eficacia intercultural de la TFF en una cultura no occidental y la transportabilidad hacia ella.
    本研究是首次在非西方文化情境里对功能性家庭治疗(FFT)进行评估。FFT的有效性与青少年罪犯康复相关的三个近端结果有关联: (i) 精神健康,(ii)家庭功能,和(iii) 缓刑实施完毕。120名青年缓刑犯 (Mage = 16.2, SD = 1.33) 被随机分配接受两种标准的缓刑服务--照常治疗(TAU; n = 57) 或FFT除TAU (FFT; n = 63)。研究者在(i)项目前、(ii)项目后和(iii)缓刑结束时获取了心理健康和家庭功能的心理测量数据。缓刑完成数据来源于个案档案记录。FFT组的平均心理健康评分从治疗前到治疗后有所改善,并在后续活动中保持改善。然而,在精神健康量表上,FFT组并没有表现出更高的可靠变化和临床康复率这一趋势并。随着时间的推移,家庭功能得分没有组别差异。然而,FFT组有一个显著的趋势,即在家庭功能量表上显示出更高的可靠改变率和临床恢复率。FFT组和TAU组的缓刑完成率分别为88.9%和70.2%。FFT组的青少年完成缓刑的可能性显著。研究结果支持了FFT在新加坡青少年罪犯中的有效性。在更广泛的层面上,研究结果支持FFT在非西方文化中的跨文化有效性,以及对非西方文化的可迁移性。.
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  • 文章类型: Journal Article
    BACKGROUND: Subjective well-being (SWB) refers to being satisfied with one\'s life, having positive affect and having little negative affect. We may understand it as a subjective definition of good life, or in colloquial terms \"happiness\", and it has been associated with several important benefits such as lower mortality. In the last decades, several randomized controlled trials (RCT) have investigated the efficacy of several interventions in increasing SWB in the general population but results from different disciplines have not been integrated.
    METHODS: We conducted an umbrella review of systematic reviews and meta-analyses of RCT that assess the efficacy of any kind of interventions in increasing SWB in the general population, including both positive psychology interventions (PPI) and other interventions. We (re)calculated the meta-analytic statistics needed to objectively assess the quality of the evidence of the efficacy of each type of intervention in improving each component of SWB according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
    RESULTS: There was moderate-quality evidence that PPI might induce small decreases of negative affect, and low-quality evidence that they might induce moderate increases of positive affect. We found similar results for those PPI specifically consisting in conducting acts of kindness (especially spending money on or giving items to others), for which there was low-quality evidence that they might induces small increases of life satisfaction, but not for PPI specifically consisting in practicing gratitude. Quality of the evidence of the efficacy for the other interventions included in the umbrella review (yoga, resilience training, physical activity, leisure, control enhancement, psychoeducation, and miscellaneous) was very low.
    CONCLUSIONS: There is some evidence that PPI, and specially conducting acts of kindness such as spending money on others, may increase the SWB of the general population. The quality of the evidence of the efficacy for other interventions (e.g., yoga, physical activity, or leisure) is still very low. Registration number: PROSPERO CRD42020111681.
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  • 文章类型: Journal Article
    We aimed to assess the overall effect of pelvic muscle training (PFMT) on patients with pelvic organ prolapse (POP) based on eligible randomized controlled trials (RCT).
    We searched the following databases, such as PubMed, Cochrane, and Embase, to identify eligible RCT based on the index words updated to December 2018. We also searched the publications related to the present study. Odds rations (OR), and mean difference (MD) along with 95% confidence interval (95% CI) were used to analyze the main outcomes.
    In this meta-analysis, 15 RCTs were included with a total of 1309 patients in the PFMT group and a total of 1275 patients in the control group. The overall results showed no significant difference in the incidence of add 2 POP-Q stages (RR: 0.55, 95%CI: 0.19-1.63), add 1 POP-Q stages (RR: 1.04, 95%CI: 0.69-1.57), no POP-Q stages change (RR: 0.94, 95%CI: 0.81-1.09), reduce 2 POP-Q stages (RR: 1.72, 95%CI: 0.79-3.76), self-reported same symptom change (RR: 0.70, 95%CI: 0.45-1.09), and self-reported worse symptom change (RR: 0.67, 95%CI: 0.22-2.03) between the 2groups. Besides, the incidence of reduce 1 POP-Q stages was significantly higher in the PFMT group than that of the control group (RR: 1.80, 95%CI: 1.20-2.69), and the PFMT significantly changed the self-reported symptoms with better outcomes when compared with the control group (RR: 2.90, 95%CI: 1.72-4.89). However, after the therapy, the PFMT group decreased the POP-SS (SMD: -0.24, 95%CI: -0.71-0.22), POPDI-6 (SMD: -0.14, 95%CI: -0.43-0.15), CRADI-8 (SMD: -0.03, 95%CI: -0.16-0.11), and UDI-6 (SMD: -0.17, 95%CI: -0.43-0.10) versus the control group, but without statistical significance.
    PMFT showed better effect in reducing 1 POP-Q stages, changing the self-reported symptoms with better outcomes, decreasing the score of POP-SS, POPDI-6, CRADI-8, and UDI-6 in women with POP versus the control group. However, more high-quality multicenter RCTs with a larger sample size are needed to confirm the present conclusions.
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  • 文章类型: Journal Article
    This randomized controlled trial (RCT) aimed to pilot the newly developed manualized and monitored systemic therapy (ST) for social anxiety disorder (SAD), as compared to manualized and monitored cognitive behavioral therapy (CBT). We conducted a prospective multicenter, assessor-blind pilot RCT on 38 outpatients (ICD F40.1; Structured Clinical Interview for DSM (SCID); Liebowitz Social Anxiety Scale, LSAS-SR >30). The primary outcome was level of social anxiety (LSAS-SR) at the end of treatment. A total of 252 persons were screened, and 38 patients were randomized and started therapy (CBT: 20 patients; ST: 18 patients; age: M = 36 years, SD = 14). Within-group, simple-effect intent-to-treat analyses (ITT) showed significant reduction in LSAS-SR (CBT:d = 1.04; ST:d = 1.67), while ITT mixed-design ANOVA demonstrated the advantage of ST (d = 0.81). Per-protocol analyses supported these results. Remission based on reliable change indices also demonstrated significant difference (LSAS-SR: 15% in CBT; 39% in ST;h: 0.550), supported by blind diagnosticians\' ratings of those who completed therapy (SCID; 45% in CBT, 78% in ST,p = .083). No adverse events were reported. CBT and ST both reduced social anxiety, supporting patient improvement with the newly developed ST for SAD; this has yet to be verified in a subsequent confirmatory RCT.
    Este ensayo controlado aleatorizado tuvo como finalidad probar la terapia sistémica (TS) estandarizada y monitoreada recientemente desarrollada para el trastorno de ansiedad social en comparación con la terapia cognitivo-conductual (TCC) estandarizada y monitoreada. Realizamos un ensayo controlado aleatorizado prospectivo, multicentro y con enmascaramiento para el evaluador en 38 pacientes ambulatorios (CIE F40.1; Entrevista Clínica Estructurada para los trastornos del DSM (SCID); Escala de Ansiedad Social de Liebowitz, LSAS-SR > 30). El resultado principal fue el nivel de ansiedad social (LSAS-SR) al final del tratamiento. Se evaluó a un total de 252 personas, 38 pacientes fueron aleatorizados y comenzaron la terapia (TCC: 20 pacientes; TS: 18 pacientes; edad: promedio= 36 años, desviación estándar = 14). Los análisis intragrupales, de efecto simple, con intención de tratar demostraron una reducción significativa del LSAS-SR (TCC: d = 1.04; TS: d = 1.67), mientras que el análisis de varianza de diseño mixto con intención de tratar demostró la ventaja de la TS (d = 0.81). Los análisis por protocolo respaldaron estos resultados. La remisión basada en los índices de cambio fiable también demostró una diferencia significativa (LSAS-SR: 15% en la TCC; 39% en la TS; h: 0.550), respaldada por diferencias casi significativas en las valoraciones con enmascaramiento para los evaluadores de aquellos que completaron la terapia (SCID; 45% en la TCC, 78% en la TS, p = 0.083). No se informaron efectos adversos. Tanto la TCC como la TS reducen la ansiedad social y respaldan la mejora de los pacientes con la terapia sistémica recientemente desarrollada para los trastornos de ansiedad social; esto aun debe verificarse en un ensayo controlado aleatorizado confirmatorio posterior.
    本研究中的随机控制试验(RCT)是一个对新开发的系统治疗(ST)的初步研究,该系统治疗是针对社交恐惧症(SAD)的有指导性和监控性的疗法 ,文中与之比较的是有指导性和监控性的认知行为疗法(CBT)。我们的研究对象是38个门诊病人(ICD F40.1;对DSM的结构性临床访谈(SCID);列博维茨社交恐惧等级量表,LSAS-SR在30以上),他们接受了预期的多中心的,测评者身份不告知的随机控制实验(RCT)。主要结果查看的是治疗结束后的社交焦虑LSAS-SR水平。252个人接受筛查,38个病人被随机安排接受治疗(认知行为疗法CBT: 20 个病人; 系统治疗ST: 18个病人; age: 年龄中位数 M = 36 岁, 标准方差 SD = 14)。在群组内,目的导向治疗意向性分析表明 LSAS-SR (CBT: d = 1.04; ST: d = 1.67)有显著性降低,而ITT混合设计方差分析证明ST的优势(d = 0.81)。符合计划人群分析结果支持了以上结论。基于可信改变指数RCI的变小也证实了显著性差异性(LSAS-SR: 15% in CBT; 39% in ST; h: 0.550),这个类似的显著性差异也被那些完成了治疗后的匿名诊断测评的结果支持(SCID; 45% in CBT, 78% in ST, p = 0.083)。尚未出现报告的逆向性的事件。认知行为治疗CBT和系统治疗ST都可以降低社交焦虑,通过新开发的针对社交恐惧症SAD的系统治疗ST促进了病人的好转 ;但是,这还需要在接下来的证实性的“随机控制试验” (RCT)中得到进一步证明。.
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