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针对炎症性肠病患者 COVID-19 大流行相关困扰的表达性写作干预研究(WriteForIBD):一项试验方案。

Expressive writing to combat distress associated with the COVID-19 pandemic in people with inflammatory bowel disease (WriteForIBD): A trial protocol.

机构信息

School of Psychology, Deakin University, Melbourne, Australia.

School of Psychology, Deakin University, Melbourne, Australia; IMPACT, School of Medicine, Deakin University, Geelong, Australia.

出版信息

J Psychosom Res. 2020 Dec;139:110286. doi: 10.1016/j.jpsychores.2020.110286. Epub 2020 Nov 4.

Abstract

OBJECTIVE

A large proportion of patients with inflammatory bowel disease (IBD) receive immunosuppressive medication, may be at higher risk of complications if they contract SARS-CoV-2 virus, and therefore report high levels of COVID-19-related distress. This trial will evaluate a brief, evidence-based, online, group-based expressive writing intervention to reduce COVID-19-related distress in people living with IBD at the time of pandemic.

METHODS

A parallel double-blind randomised controlled trial will be conducted. Overall, up to 154 adult participants with IBD and mild-moderate distress will be recruited via patient organisations. Participants will be allocated to the expressive writing intervention or an active control group. All participants will complete questionnaires including measures of distress, quality of life, resilience, self-efficacy, social support and disease activity before and after the intervention (1 week) and at 3 months post-intervention. The expressive writing group will participate in the evidenced-based 4-day writing program adapted from Pennebaker and Beall, 1986. The active control group will write about untherapeutic topics provided by researchers. Statistical analysis will be carried out on an intention-to-treat basis and will involve linear mixed effects models.

CONCLUSIONS

If successful, this simple intervention may bring personal and societal benefits, particularly because it is low cost, can be easily implemented online, ensuring social distancing, and be made widely available, during future disasters and to help with trauma-related distress in IBD.

TRIAL REGISTRATION

The trial has been prospectively registered in the Australian New Zealand Trial Registry - ACTRN12620000448943p.

摘要

目的

相当一部分炎症性肠病(IBD)患者接受免疫抑制药物治疗,如果感染 SARS-CoV-2 病毒,他们可能面临更高的并发症风险,因此报告了较高水平的 COVID-19 相关困扰。本试验将评估一种简短、基于证据的在线团体表达性写作干预措施,以降低大流行期间 IBD 患者的 COVID-19 相关困扰。

方法

将开展一项平行、双盲、随机对照试验。总共将通过患者组织招募 154 名患有 IBD 和轻度中度困扰的成年参与者。参与者将被分配到表达性写作干预组或积极对照组。所有参与者将在干预(1 周)前后和干预后 3 个月完成问卷,包括困扰、生活质量、韧性、自我效能、社会支持和疾病活动的测量。表达性写作组将参与基于 Pennebaker 和 Beall,1986 年的 4 天写作方案。积极对照组将根据研究人员提供的非治疗性主题进行写作。统计分析将基于意向治疗进行,并将涉及线性混合效应模型。

结论

如果成功,这种简单的干预措施可能会带来个人和社会效益,特别是因为它成本低,易于在线实施,确保社交距离,并在未来的灾难中广泛提供,以帮助 IBD 患者减轻与创伤相关的困扰。

试验注册

该试验已在澳大利亚和新西兰临床试验注册中心前瞻性注册 - ACTRN12620000448943p。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47d8/7609228/1435908bd5e0/gr1_lrg.jpg

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