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针对多发性硬化症患者照料者的心理教育干预措施:一项随机试验方案

Psychoeducational Interventions for Caregivers of Persons With Multiple Sclerosis: Protocol for a Randomized Trial.

作者信息

Douglas Sara L, Plow Matthew, Packer Tanya, Lipson Amy R, Lehman Michelle J

机构信息

School of Nursing, Case Western Reserve University, Cleveland, OH, United States.

School of Occupational Therapy, Dalhousie University, Halifax, NS, Canada.

出版信息

JMIR Res Protoc. 2021 Aug 26;10(8):e30617. doi: 10.2196/30617.

Abstract

BACKGROUND

Of the approximately 1 million people living with multiple sclerosis in the United States, more than half receive informal, unpaid care or support from family or friends (caregivers). These caregivers report high levels of stress, anxiety, and negative emotions. Few researchers have conducted psychoeducational interventions for these caregivers.

OBJECTIVE

This paper presents a protocol for a randomized clinical trial that aims to test the efficacy of two interventions for improving stress, anxiety, depression, and negative emotions for caregivers of persons with multiple sclerosis.

METHODS

Participants included any self-identified family or friend caregiver of a person with multiple sclerosis. Data collection began in April 2021 and is expected to continue until November 2021. Participants will be randomized to receive either a website-only or a website-coaching intervention delivered for 6 weeks. Data will be collected at baseline, 6 weeks after baseline (after delivery of intervention), and 6 weeks later.

RESULTS

The protocol was approved by the institutional review board of the Case Western Reserve University on January 21, 2021 (protocol 20201484). As of May 2021, 66 participants were enrolled.

CONCLUSIONS

Our findings will have implications for identifying the efficacy of two types of interventions developed for caregivers of persons with multiple sclerosis to reduce negative psychological outcomes associated with caregiving.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04662008; http://clinicaltrials.gov/ct2/show/NCT04662008.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30617.

摘要

背景

在美国,约100万多发性硬化症患者中,超过半数接受家人或朋友(照料者)的非正式、无偿照料或支持。这些照料者报告称压力、焦虑和负面情绪程度很高。很少有研究人员针对这些照料者开展心理教育干预。

目的

本文介绍一项随机临床试验方案,旨在测试两种干预措施对改善多发性硬化症患者照料者的压力、焦虑、抑郁和负面情绪的效果。

方法

参与者包括任何自认为是多发性硬化症患者的家人或朋友照料者。数据收集于2021年4月开始,预计持续至2021年11月。参与者将被随机分配接受为期6周的仅网站干预或网站辅导干预。将在基线、基线后6周(干预实施后)和6周后收集数据。

结果

该方案于2021年1月21日获得凯斯西储大学机构审查委员会批准(方案20201484)。截至2021年5月,已招募66名参与者。

结论

我们的研究结果将有助于确定为多发性硬化症患者照料者开发的两种干预措施在减少与照料相关的负面心理结果方面的效果。

试验注册

ClinicalTrials.gov NCT04662008;http://clinicaltrials.gov/ct2/show/NCT04662008。

国际注册报告识别码(IRRID):DERR1-10.2196/30617。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26e8/8430872/646f3386ae5d/resprot_v10i8e30617_fig1.jpg

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