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，使用刺激剂（例如甲基苯丙胺）的艾滋病毒阳性人的传播风险增加了耐药菌株HIV的风险。心理健康的合并症，例如后应激障碍的症状和HIV特异性的创伤性压力，可能有助于增加HIV阳性人的刺激使用。因此，旨在解决创伤性压力的辅助心理健康干预措施最终可以改善滥用药物治疗结果，并减少使用HIV阳性甲基苯丙胺男性的传播风险行为。特别是，表达性写作是一种基于暴露的自我管理的，可以解决创伤，可以轻松地将其传播到药物滥用治疗计划中，而无需给员工带来额外的额外负担以进行培训或干预措施。在过去的20年中，许多随机对照试验（RCT）检查了自我管理的表达性写作干预措施的疗效，询问参与者在1-5天内写下15-30分钟的创伤事件。荟萃分析的发现观察到，表达性写作干预措施可改善心理调整，生理功能和各种人群中自我报告的身体健康。但是，据我们所知，尚无公开的研究研究了与活跃的吸毒者表达性写作的功效。拟议的形成性临床研究将研究为使用HIV阳性甲基苯丙胺的男性提供自我管理的表达写作干预的安全性，可行性和潜在的临床实用性。为了评估富有表现力的写作，我们将使用90个使用甲基苯丙胺的男性进行飞行员RCT。除了提供有关安全性和可行性的数据外，此RCT还将提供一个机会，以检查表达性写作对心理调整度量（主要结果）的潜在临床实用性，以及药物使用和HIV传播风险行为（次要结果）。确定表达性写作是安全，可行的，并且可能对这个人群有效，这是通知计划的临床研究计划的关键第一步。随后的临床研究将检查表达性写作是否可以作为使用HIV阳性甲基苯丙胺的男性对药物滥用治疗的有效佐剂。提高药物滥用治疗对艾滋病毒阳性甲基苯丙胺的男性的有效性将减轻人类的痛苦，并最终降低HIV传播率。公共卫生相关性：拟议的飞行员随机对照试验解决了与男性发生性关系的艾滋病毒阳性甲基苯丙胺男性（MSM）面临的关键公共卫生问题。通过检查使用HIV阳性甲基苯丙胺使用MSM进行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实用性，这项研究有可能为开发综合方法提供努力，从而提高正式药物滥用治疗的有效性。改善使用HIV阳性甲基苯丙胺的MSM中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，并减少抗药性HIV菌株的传播。