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一项支持痴呆症患者家庭及其他无偿照料者的在线最低限度指导干预措施:一项随机对照试验的方案

An Online Minimally Guided Intervention to Support Family and Other Unpaid Carers of People With Dementia: Protocol for a Randomized Controlled Trial.

作者信息

Pinto-Bruno Ángel C, Pot Anne Margriet, Kleiboer Annet, Droes Rose-Marie, van Straten Annemieke

机构信息

Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.

School of Psychology, University of Queensland, Brisbane, Australia.

出版信息

JMIR Res Protoc. 2019 Oct 10;8(10):e14106. doi: 10.2196/14106.

Abstract

BACKGROUND

About three-quarters of people with dementia live in their own homes, with help from family members and/or other unpaid carers, such as friends or neighbors. Often, unpaid carers themselves experience negative consequences, such as stress, burden, and symptoms of depression or anxiety. Research has shown that these consequences can be alleviated by psychosocial and psychological interventions. Moreover, there are indications that those interventions can be effective when offered online.

OBJECTIVE

This paper describes the protocol of a randomized controlled trial (RCT) that will take place in the Netherlands to evaluate the effectiveness of iSupport, a minimally guided, internet-based intervention to improve carers' mental health and coping resources.

METHODS

A superiority two-arm RCT comparing the effects of the online support program with a waiting list control condition will be carried out in the Netherlands. The iSupport intervention was developed by the World Health Organization and is based on cognitive behavioral therapy principles. It has five main themes divided into 23 lessons. Carers can pick and choose which lessons they want to complete. We aim to recruit 200 unpaid carers. The experimental group (n=100) will be provided with access to the intervention for 3 months following randomization; those in the waiting list control group (n=100) will be granted access to the intervention after 3 months. Assessments will be conducted at baseline (T0), 3 months after baseline (post intervention, T1), and 6 months after baseline (follow-up, T2). The primary outcome is perceived stress, measured by the Perceived Stress Scale. Secondary outcomes are symptoms of depression and anxiety, caregiver burden, sense of competence, self-efficacy, mastery, and carers' attitudes toward dementia and their person-centered approach (ie, to what extent carers tailor the provided care to the interest, needs, and history of the person with dementia).

RESULTS

Recruitment for the trial started in January 2019. As of July 2019, we have enrolled 120 participants. Data collection is expected to be completed by March 2020. Once all the data have been collected, we will conduct the data analyses between April and May 2020. We aim to publish our results in a manuscript by June 2020.

CONCLUSIONS

Online interventions have shown promising results in improving the mental health of carers of people with dementia. Additionally, online interventions may overcome accessibility barriers. If successful, this intervention will have important potential for implementation as a public health intervention, since costs and support by trained staff are minimal.

TRIAL REGISTRATION

Netherlands Trial Register (NTL) NL6417; https://www.trialregister.nl/trial/6417.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14106.

摘要

背景

约四分之三的痴呆症患者在家人和/或其他无偿照顾者(如朋友或邻居)的帮助下居家生活。无偿照顾者自身常常会经历一些负面后果,如压力、负担以及抑郁或焦虑症状。研究表明,社会心理和心理干预可以缓解这些后果。此外,有迹象表明,这些干预在线提供时也能有效。

目的

本文描述了一项将在荷兰进行的随机对照试验(RCT)方案,以评估iSupport的有效性,iSupport是一种基于网络的、极少指导的干预措施,旨在改善照顾者的心理健康和应对资源。

方法

在荷兰将开展一项优效性双臂RCT,比较在线支持项目与等待名单对照条件的效果。iSupport干预由世界卫生组织开发,基于认知行为疗法原则。它有五个主要主题,分为23课。照顾者可以挑选他们想要完成的课程。我们的目标是招募200名无偿照顾者。随机分组后,实验组(n = 100)将有3个月的时间使用该干预措施;等待名单对照组(n = 100)的参与者将在3个月后获得使用该干预措施的机会。评估将在基线(T0)、基线后3个月(干预后,T1)和基线后6个月(随访期后,T2)进行。主要结局是用感知压力量表测量的感知压力。次要结局包括抑郁和焦虑症状、照顾者负担、胜任感、自我效能感、掌控感,以及照顾者对痴呆症的态度及其以患者为中心的护理方式(即照顾者根据痴呆症患者的兴趣、需求和病史调整所提供护理的程度)。

结果

该试验于2019年1月开始招募。截至2019年7月,我们已招募了120名参与者。预计数据收集将于2020年3月完成。一旦所有数据收集完毕,我们将在2020年4月至5月进行数据分析。我们的目标是在2020年6月前以一篇论文的形式发表研究结果。

结论

在线干预在改善痴呆症患者照顾者的心理健康方面已显示出有前景的结果。此外,在线干预可能会克服可及性障碍。如果成功,这项干预作为一种公共卫生干预措施实施将具有重要潜力,因为成本和对专业人员的需求极少。

试验注册

荷兰试验注册库(NTL)NL6417;https://www.trialregister.nl/trial/6417。

国际注册报告识别号(IRRID):DERR1-10.2196/14106。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4da1/6819009/5683e4a30c3b/resprot_v8i10e14106_fig1.jpg

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