Rexhaj Shyhrete, Monteiro Shadya, Golay Philippe, Coloni-Terrapon Claire, Wenger Daniel, Favrod Jérôme
La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland
La Source, School of Nursing, University of Applied Sciences and Arts Western Switzerland, HES-SO, Lausanne, Vaud, Switzerland.
BMJ Open. 2020 Jul 30;10(7):e038781. doi: 10.1136/bmjopen-2020-038781.
Informal caregivers play a major role in the support and maintenance of community patients with severe psychiatric disorders. A pilot study showed that an individualised brief intervention such as the Ensemble programme leads to significant improvements in psychological health state and optimism.
This randomised controlled trial aims to compare the efficacy of using Ensemble in improving informal caregivers' psychological health states and the ability to play an active role in their situations with that of support as usual. Improvements on the psychological health global index will be measured three times (T0-pre, T1-post and T3 2 months follow) with standardised questionnaires (the Global Severity Index of Brief Inventory Symptoms, the Life Orientation Test-Revised, the 36-item Medical Outcome Study Short-Form Health Survey and the French Zarit Burden Interview). Differences between groups in post-test and pretest values will be examined using an analysis of covariance for each outcome variable. The severity of illness measured by the Social and Occupational Functioning Assessment Scale will also be collected at T0 and T2 to compare eventual patient improvements. At the end of the programme, the experiences of the 20 patients participating in the Ensemble programme will be evaluated qualitatively.
The research protocol received full authorisation from the Human Research Ethics Committee of the Vaud state, Switzerland. The principal paper will concern the results of the experimental design used to test the Ensemble programme. The research team will prioritise open access publications.
NCT04020497.
非正式照护者在支持和照料患有严重精神疾病的社区患者方面发挥着重要作用。一项试点研究表明，诸如“Enseble项目”这样的个性化简短干预可显著改善心理健康状况并提升乐观情绪。
本随机对照试验旨在比较使用“Enseble项目”改善非正式照护者心理健康状况以及使其在自身处境中发挥积极作用的效果与常规支持的效果。将使用标准化问卷（简短症状量表的总体严重程度指数、修订版生活取向测试、36项医学结局研究简表健康调查以及法国扎里特负担访谈）对心理健康综合指数进行三次测量（T0 - 干预前、T1 - 干预后以及T3 - 2个月随访）。对于每个结局变量，将使用协方差分析来检验组间后测值与前测值之间的差异。还将在T0和T2收集由社会和职业功能评估量表测量的疾病严重程度，以比较患者最终的改善情况。在项目结束时，将对参与“Enseble项目”的20名患者的体验进行定性评估。
该研究方案已获得瑞士沃州人类研究伦理委员会的完全批准。主要论文将关注用于测试“Enseble项目”的实验设计结果。研究团队将优先考虑开放获取出版物。
NCT04020497。
