Protocolo de estudio

  • 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: Clinical Trial Protocol
    背景:大流行期间的应激事件是严重健康问题的主要原因,比如倦怠,医护人员(HCWs)中的抑郁和创伤后应激障碍(PTSD)。三年来,HCWs,在抗击COVID-19大流行的前线,承受高压力的风险增加,焦虑,抑郁症,倦怠和创伤后应激障碍。关于潜在的心理干预,眼动脱敏和后处理(EMDR)是一种结构化的,基于其在减轻PTSD症状和焦虑方面的众所周知的功效,强烈推荐治疗。目的:本研究,设计为队列中的试验(TwiC),旨在1)估计抑郁症的患病率,经历COVID-19紧急情况后的HCW样本中的倦怠和创伤后应激障碍(队列部分)和2)评估报告显著心理症状的队列中的HCW的“EMDR+常规护理”的疗效和可接受性(试验部分)。方法:研究,被设计成Twic,由一项前瞻性队列研究(n=3000)组成,务实,随机开放标签优势试验分为两组(n=900).纳入试验部分的参与者是为队列招募的HCWs,在至少一个心理维度上有显著症状(抑郁,倦怠,PTSD)在基线时,3个月或6个月,通过使用患者健康问卷(PHQ-9)确定,专业生活质量(ProQOL)量表,和DSM-5(PCL-5)的PTSD清单。干预措施包括与经过认证的治疗师进行的12次独立的EMDR课程。对照组接受常规护理。该试验有三个主要结果:抑郁症的变化,从随机化到6个月的倦怠和PTSD评分。所有参与者均随访12个月。结论:这项研究提供了有关COVID-19大流行的影响及其对医护人员的心理健康负担的经验证据,并评估了EMDR作为心理干预的有效性。试用登记NCT04570202。
    医护人员的压力风险增加,焦虑,抑郁症,COVID-19大流行后的倦怠和创伤后应激障碍。在这项研究中,EMDR在减少抑郁方面的有效性,调查了接触COVID-19的医护人员的倦怠和创伤后应激障碍。在这项研究中,使用原始的“队列内试验”(TwiC)设计,该设计由一项队列研究和一项嵌入式实用随机试验组成.这项研究完全基于网络,包括在线筛查,同意和评估。
    Background: Stressful events during a pandemic are a major cause of serious health problems, such as burnout, depression and posttraumatic stress disorder (PTSD) among health care workers (HCWs). During three years, HCWs, on the frontline to fight the COVID-19 pandemic, have been at an increased risk of high levels of stress, anxiety, depression, burnout and PTSD. Regarding potential psychological interventions, Eye Movement Desensitization & Reprocessing (EMDR) is a structured, strongly recommended therapy based on its well-known efficacy in reducing PTSD symptoms and anxiety.Objectives: This study, designed as a trial within a cohort (TwiC), aims to 1) estimate the prevalence of depression, burnout and PTSD in a sample of HCWs after experiencing the COVID-19 emergency (cohort part) and 2) assess the efficacy and acceptability of \'EMDR + usual care\' for HCWs from the cohort who report significant psychological symptoms (trial part).Methods: The study, designed as a TwiC, consists of a prospective cohort study (n = 3000) with an embedded, pragmatic, randomized open-label superiority trial with two groups (n = 900). Participants included in the trial part are HCWs recruited for the cohort with significant symptoms on at least one psychological dimension (depression, burnout, PTSD) at baseline, 3 months or 6 months, determined by using the Patient Health Questionnaire (PHQ-9), Professional Quality of Life (ProQOL) scale, and PTSD Checklist for the DSM-5 (PCL-5). The intervention consists of 12 separate EMDR sessions with a certified therapist. The control group receives usual care. The trial has three primary outcomes: changes in depression, burnout and PTSD scores from randomization to 6 months. All participants are followed up for 12 months.Conclusions: This study provides empirical evidence about the impact of the COVID-19 pandemic and the mental health burden it places on HCWs and assesses the effectiveness of EMDR as a psychological intervention.Trial registration NCT04570202.
    Health care workers are at increased risk of stress, anxiety, depression, burnout and PTSD following the COVID-19 pandemic.In this study, the effectiveness of EMDR in reducing depression, burnout and PTSD in health care workers exposed to COVID-19 is investigated.In this study, an original ‘trial within a cohort’ (TwiC) design that consists of a cohort study with an embedded pragmatic randomized trial is used.The study is fully web-based, including online screening, consent and assessments.
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