A Pilot RCT of Expressive Writing with HIV-Positive Methamphetamine Users

HIV 阳性甲基苯丙胺使用者的表达性写作试点随机对照试验

基本信息

批准号：
7922469
负责人：
Adam Wayne Carrico
金额：
$ 12.31万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-01 至 2012-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7922469
关键词：
AIDS/HIV problem Acquired Immunodeficiency Syndrome Address Adjuvant Adverse event Alcohol or Other Drugs use Attention Award Behavior Clinical Clinical Research Comorbidity Data Deterioration Drug user Effectiveness Epidemic Event Goals HIV HIV Seropositivity Human Intervention Knowledge Life Experience Measures Mental Health Meta-Analysis Methamphetamine Methods Monitor Moods National Institute of Drug Abuse Participant Patient Self-Report Persons Pharmaceutical Preparations Physiological Population Post-Traumatic Stress Disorders Psychological adjustment Public Health Publishing Randomized Randomized Controlled Trials Reporting Research Research Design Research Personnel Risk Risk Behaviors Risk-Taking Safety Schedule Science Self-Administered Stress Substance abuse problem Symptoms Training Trauma Treatment outcome Visit Writing base clinically significant expressive writing follow-up improved men men who have sex with men physical conditioning primary outcome programs public health relevance resistant strain response secondary outcome stem substance abuse treatment therapy design transmission process treatment program

项目摘要

DESCRIPTION (provided by applicant): It is well established that HIV-positive persons who use stimulants such as methamphetamine are at increased risk for transmitting medication-resistant strains HIV. Mental health co-morbidities such as symptoms of post- traumatic stress disorder and HIV-specific traumatic stress may substantially contribute to increased stimulant use among HIV-positive persons. Consequently, adjuvant mental health interventions designed to address traumatic stress could ultimately improve substance abuse treatment outcomes and reduce transmission risk behavior among HIV-positive methamphetamine-using men. In particular, expressive writing is a self- administered, exposure-based intervention to address trauma that could be easily disseminated to substance abuse treatment programs without placing significant additional burden on staff for training or intervention delivery. Over the past 20 years, numerous randomized controlled trials (RCTs) have examined the efficacy of self-administered expressive writing interventions where participants are asked write about traumatic events for 15 - 30 minutes over 1 - 5 days. Findings from meta-analyses observed that expressive writing interventions improve psychological adjustment, physiological functioning, and self-reported physical health in various populations. However, to our knowledge no published research has examined the efficacy of expressive writing with active drug users. The proposed formative clinical research will examine the safety, feasibility, and potential clinical utility of delivering a self-administered, expressive writing intervention to HIV-positive methamphetamine-using men. In order to evaluate expressive writing, we will conduct a pilot RCT with 90 HIV-positive methamphetamine-using men. In addition to providing data on safety and feasibility, this RCT will provide an opportunity to examine the potential clinical utility of expressive writing with respect to measures of psychological adjustment (primary outcome) as well as substance use and HIV transmission risk behavior (secondary outcomes). Establishing that expressive writing is safe, feasible, and potentially efficacious with this population represents a crucial first step to inform a planned clinical research program. Subsequent clinical research will examine whether expressive writing can serve as an efficacious adjuvant to substance abuse treatment with HIV-positive methamphetamine-using men. Improving the effectiveness of substance abuse treatment for HIV-positive methamphetamine-using men would alleviate human suffering and could ultimately reduce HIV transmission rates. PUBLIC HEALTH RELEVANCE: The proposed pilot randomized controlled trial addresses a critical public health issue facing HIV-positive methamphetamine-using men who have sex with men (MSM). By examining the safety, feasibility, and potential clinical utility of a self-administered expressive writing intervention with HIV-positive methamphetamine-using MSM, this study has the potential to inform efforts to develop integrative approaches that boost the effectiveness of formal substance abuse treatment with this population. Improving substance abuse treatment outcomes among HIV-positive methamphetamine-using MSM could ultimately alleviate human suffering associated with substance abuse and reduce the transmission of medication-resistant strains of HIV.

描述（由申请人提供）：众所周知，使用甲基苯丙胺等兴奋剂的艾滋病毒阳性者传播耐药性艾滋病毒株的风险会增加。心理健康合并症，例如创伤后应激障碍和艾滋病毒特异性创伤应激症状，可能会在很大程度上导致艾滋病毒阳性者使用兴奋剂的增加。因此，旨在解决创伤性应激的辅助心理健康干预措施最终可以改善药物滥用治疗结果，并减少使用甲基苯丙胺的艾滋病毒阳性男性的传播风险行为。特别是，表达性写作是一种自我管理的、基于暴露的干预措施，用于解决创伤问题，可以很容易地传播到药物滥用治疗项目中，而不会给工作人员带来培训或干预实施的重大额外负担。在过去的 20 年里，大量随机对照试验 (RCT) 检验了自我执行的表达性写作干预措施的有效性，其中参与者被要求在 1 - 5 天内写下 15 - 30 分钟的创伤事件。荟萃分析的结果表明，表达性写作干预可以改善不同人群的心理调整、生理功能和自我报告的身体健康状况。然而，据我们所知，尚无已发表的研究检验过表达性写作对活跃吸毒者的功效。拟议的形成性临床研究将检验向使用甲基苯丙胺的艾滋病毒阳性男性提供自我管理的表达性写作干预的安全性、可行性和潜在的临床效用。为了评估表达性写作，我们将对 90 名使用甲基苯丙胺的 HIV 阳性男性进行试点随机对照试验。除了提供安全性和可行性数据外，该随机对照试验还将提供一个机会来检验表达性写作在心理调整措施（主要结果）以及物质使用和艾滋病毒传播风险行为（次要结果）方面的潜在临床效用。。确定表达性写作对于这一人群是安全、可行且可能有效的，这是为计划中的临床研究计划提供信息的关键的第一步。随后的临床研究将检验表达性写作是否可以作为艾滋病毒阳性甲基苯丙胺男性药物滥用治疗的有效辅助手段。提高对使用甲基苯丙胺的艾滋病毒呈阳性男性的药物滥用治疗的有效性将减轻人类的痛苦，并最终降低艾滋病毒的传播率。公共卫生相关性：拟议的试点随机对照试验解决了使用甲基苯丙胺的艾滋病毒阳性男男性行为者 (MSM) 面临的一个关键公共卫生问题。通过检验使用 HIV 阳性甲基苯丙胺的 MSM 进行自我表达性写作干预的安全性、可行性和潜在临床效用，本研究有可能为开发综合方法的努力提供信息，从而提高正式药物滥用治疗的有效性。这个人口。改善使用甲基苯丙胺的艾滋病毒阳性男男性行为者的药物滥用治疗结果最终可以减轻与药物滥用相关的人类痛苦，并减少艾滋病毒耐药菌株的传播。