PDF(Pubmed)
Abstract：
UNASSIGNED: Persistent physical symptoms (PPS) refer to symptoms that cannot be fully explained by structural bodily pathology or by environmental factors. Their impact on daily functioning varies from mild to severe disability. So far, evidence-based treatments for PPS have resulted in only small to moderate effects. Treatment protocols with a stronger orientation toward personalized approaches are needed to improve the efficacy and applicability of treatment. In this study, we aim to assess the effect of an online individual case conceptualization with web-based program for PPS. This study is conducted among two focus groups: patients with indoor air-related symptoms and patients with chronic fatigue syndrome.
UNASSIGNED: Using a randomized controlled design (RCT) with two parallel groups in a 1:1 ratio, we will compare individual video-based case conceptualization with a web-based program based on Acceptance and Commitment Therapy (ACT), combined with treatment as usual, with treatment as usual only. The web-based program consists of ten modules, each lasting 1 week and including training. The planned sample size is 124 eligible patients without attrition. The primary outcome will be the health-related quality of life as measured by the 15D questionnaire. The secondary outcome measures will include questionnaires on psychiatric and physical symptoms, illness perceptions, psychological flexibility, and work ability. We will also use national registers to obtain information on the use of healthcare and social benefits to complete patient-reported outcomes. Data collection began in August 2020 and will continue until 2023.
UNASSIGNED: This trial will provide information on the effects and usefulness of an online administrated individual case conceptualization and an ACT-based web-program on PPS.
UNASSIGNED: The Ethics Committee of the Hospital District of Helsinki and Uusimaa, Finland, has granted approval for the study. The results will be published in peer-reviewed journals.
UNASSIGNED: Clinicaltrials.gov, identifier NCT04532827 preresults.
UNASSIGNED: Using a randomized controlled design (RCT) with two parallel groups in a 1:1 ratio, we will compare individual video-based case conceptualization with a web-based program based on Acceptance and Commitment Therapy (ACT), combined with treatment as usual, with treatment as usual only. The web-based program consists of ten modules, each lasting 1 week and including training. The planned sample size is 124 eligible patients without attrition. The primary outcome will be the health-related quality of life as measured by the 15D questionnaire. The secondary outcome measures will include questionnaires on psychiatric and physical symptoms, illness perceptions, psychological flexibility, and work ability. We will also use national registers to obtain information on the use of healthcare and social benefits to complete patient-reported outcomes. Data collection began in August 2020 and will continue until 2023.
UNASSIGNED: This trial will provide information on the effects and usefulness of an online administrated individual case conceptualization and an ACT-based web-program on PPS.
UNASSIGNED: The Ethics Committee of the Hospital District of Helsinki and Uusimaa, Finland, has granted approval for the study. The results will be published in peer-reviewed journals.
UNASSIGNED: Clinicaltrials.gov, identifier NCT04532827 preresults.
摘要：
未经证实：持续的身体症状（PPS）是指无法通过结构性身体病理学或环境因素完全解释的症状。它们对日常功能的影响从轻度到重度残疾不等。到目前为止,基于证据的PPS治疗仅导致小到中度效果.需要对个性化方法具有更强取向的治疗方案，以提高治疗的疗效和适用性。在这项研究中,我们的目标是通过基于网络的PPS计划评估在线个案概念化的效果.这项研究是在两个重点人群中进行的：具有室内空气相关症状的患者和患有慢性疲劳综合征的患者。
UNASSIGNED：使用具有1：1比例的两个平行组的随机对照设计（RCT），我们将比较基于个人视频的案例概念化与基于接受和承诺疗法（ACT）的基于网络的计划，如往常一样结合治疗，照常治疗。基于Web的程序由十个模块组成，每次持续1周，包括培训。计划的样本量为124名合格的无减员患者。主要结果将是通过15D问卷测量的与健康相关的生活质量。次要结果指标将包括关于精神和身体症状的问卷，疾病感知，心理灵活性，和工作能力。我们还将使用国家登记册来获取有关使用医疗保健和社会福利来完成患者报告结果的信息。数据收集于2020年8月开始，并将持续到2023年。
UNASSIGNED：该试验将提供有关在线管理的个人病例概念化和基于ACT的PPS网络程序的效果和有用性的信息。
UNASSIGNED：赫尔辛基和乌西马医院区伦理委员会，芬兰,已批准这项研究。结果将发表在同行评审的期刊上。
未经评估：Clinicaltrials.gov，标识符NCT04532827预结果。
UNASSIGNED：使用具有1：1比例的两个平行组的随机对照设计（RCT），我们将比较基于个人视频的案例概念化与基于接受和承诺疗法（ACT）的基于网络的计划，如往常一样结合治疗，照常治疗。基于Web的程序由十个模块组成，每次持续1周，包括培训。计划的样本量为124名合格的无减员患者。主要结果将是通过15D问卷测量的与健康相关的生活质量。次要结果指标将包括关于精神和身体症状的问卷，疾病感知，心理灵活性，和工作能力。我们还将使用国家登记册来获取有关使用医疗保健和社会福利来完成患者报告结果的信息。数据收集于2020年8月开始，并将持续到2023年。
UNASSIGNED：该试验将提供有关在线管理的个人病例概念化和基于ACT的PPS网络程序的效果和有用性的信息。
UNASSIGNED：赫尔辛基和乌西马医院区伦理委员会，芬兰,已批准这项研究。结果将发表在同行评审的期刊上。
未经评估：Clinicaltrials.gov，标识符NCT04532827预结果。
