A compassion microintervention targeting stress reactivity among sexual minority women and transgender/nonbinary people: Study protocol for a randomized controlled trial

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-08-08 DOI:10.1016/j.cct.2024.107660
Emily C. Helminen , Kriti Behari , Jillian R. Scheer
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引用次数: 0

Abstract

Objective

Sexual minority women (SMW) and transgender and/or nonbinary (TNB) people report more adverse health outcomes (e.g., depression, anxiety, posttraumatic stress, substance use) relative to heterosexual, cisgender people, often due to the additional stress burden from experiencing stigma. Physiological and emotional stress reactivity are mechanisms through which high cumulative stress contributes to adverse health outcomes. The randomized controlled trial (RCT) described in this study protocol examines whether a single-session compassion microintervention may attenuate physiological and emotional stress reactivity to the minority stress Trier Social Stress Test (MS-TSST) among SMW/TNB people. This study will also examine whether the compassion microintervention reduces depression, anxiety, posttraumatic stress symptoms, and substance use from baseline to one-month follow-up, and assess microintervention acceptability.

Methods

This protocol describes a two-arm parallel RCT. Participants are recruited online and at in-person events (e.g., Pride events). Participants complete baseline measures online (e.g., demographics, anxiety symptoms) and then complete an in-person lab visit that includes the compassion microintervention (or no training control). Immediately after the intervention period, participants complete the MS-TSST. Measures of physiological (i.e., blood pressure, cortisol) and emotional (i.e., negative affect, state anxiety) reactivity are collected throughout the lab visit. Participants also complete a one-month follow-up survey. Participants randomized to the microintervention are invited to complete a semi-structured virtual interview about their experiences to assess acceptability.

Conclusion

Findings from this study could provide initial evidence that compassion microinterventions show promise in addressing stigma-related stress reactivity among SMW/TNB people.

ClinicalTrials.govregistration:NCT05949060

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针对性少数群体女性和变性人/非二元人群压力反应的同情微干预:随机对照试验研究方案。
目的:与异性恋、同性性别者相比,性少数群体妇女(SMW)和跨性别者和/或非二元性别者(TNB)报告了更多的不良健康后果(如抑郁、焦虑、创伤后应激、药物使用),这通常是由于经历污名化所带来的额外压力负担。生理和情绪压力反应是高累积压力导致不良健康后果的机制。本研究方案中描述的随机对照试验(RCT)将研究单次同情微干预是否可以减轻 SMW/TNB 人对少数群体压力特里尔社会压力测试(MS-TSST)的生理和情绪压力反应。本研究还将考察从基线到一个月随访期间,同情微干预是否会减少抑郁、焦虑、创伤后应激症状和药物使用,并评估微干预的可接受性:本方案描述了一项双臂平行 RCT。参与者通过网络和现场活动(如 "骄傲 "活动)招募。参与者在网上完成基线测量(如人口统计学、焦虑症状),然后完成包括同情微干预(或无培训对照)在内的亲临实验室访问。干预期结束后,参与者立即完成 MS-TST。在整个实验室访问期间,将收集生理(即血压、皮质醇)和情绪(即负面情绪、状态焦虑)反应性的测量数据。参与者还要完成为期一个月的跟踪调查。随机接受微干预的参与者将受邀完成一次半结构化虚拟访谈,讲述他们的经历,以评估接受度:这项研究的结果可以提供初步证据,证明同情微干预有望解决 SMW/TNB 患者与污名相关的压力反应。
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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