Emily C. Helminen , Kriti Behari , Jillian R. Scheer
{"title":"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。","authors":"Emily C. Helminen , Kriti Behari , Jillian R. Scheer","doi":"10.1016/j.cct.2024.107660","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Conclusion</h3><p>Findings from this study could provide initial evidence that compassion microinterventions show promise in addressing stigma-related stress reactivity among SMW/TNB people.</p><p><span><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg></span><strong>registration:</strong><span><span>NCT05949060</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107660"},"PeriodicalIF":2.0000,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A compassion microintervention targeting stress reactivity among sexual minority women and transgender/nonbinary people: Study protocol for a randomized controlled trial\",\"authors\":\"Emily C. Helminen , Kriti Behari , Jillian R. Scheer\",\"doi\":\"10.1016/j.cct.2024.107660\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Conclusion</h3><p>Findings from this study could provide initial evidence that compassion microinterventions show promise in addressing stigma-related stress reactivity among SMW/TNB people.</p><p><span><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg></span><strong>registration:</strong><span><span>NCT05949060</span><svg><path></path></svg></span></p></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"145 \",\"pages\":\"Article 107660\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-08-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S155171442400243X\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S155171442400243X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
A compassion microintervention targeting stress reactivity among sexual minority women and transgender/nonbinary people: Study protocol for a randomized controlled trial
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.
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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