Optimal Endpoints in Clinical Trials of Cognitive Behavioral Interventions for AOD: An Aggregate and Individual Patient Data Meta-Analysis

AOD 认知行为干预临床试验的最佳终点：总体和个体患者数据荟萃分析

• 批准号: 10517932
• 负责人: Molly Magill
• 金额: $ 61.77万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10517932
• 关键词: Abstinence; Adolescent; Alcohol consumption; Alcohol or Other Drugs use; Alcohols; Behavior Therapy; Behavioral; Benchmarking; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Trials; Cognitive; Cognitive Science; Cognitive Therapy; Consumption; Coping Behavior; Coping Skills; Data; Development; Drug Use Disorder; Economic Burden; Effectiveness; Evidence based treatment; Failure; Family; Frequencies; Future; Guidelines; Health; Heavy Drinking; Heterogeneity; Individual; International; Intervention; Justice; Literature; Longevity; Manuscripts; Measures; Mediating; Mediator of activation protein; Mental Health; Meta-Analysis; Metadata; Methodology; Methods; Modeling; Motivation; National Institute on Alcohol Abuse and Alcoholism; Outcome; Outcome Study; Outcomes Research; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Population; Process; Provider; Psyche structure; Public Health; Publishing; Quality of life; Randomized Clinical Trials; Recommendation; Recovery; Relapse; Reporting; Research; Sample Size; Sampling; Self Efficacy; Self-Direction; Social support; Subgroup; Substance Use Disorder; Surveys; Symptoms; Therapeutic; Time; Trauma; Treatment Efficacy; United States; United States Substance Abuse and Mental Health Services Administration; Update; Work; World Health Organization; alcohol and other drug; alcohol use disorder; base; behavioral pharmacology; biopsychosocial; brief intervention; clinical application; clinically significant; contextual factors; cost; craving; direct patient care; disorder later incidence prevention; efficacy evaluation; experience; follow-up; implementation intervention; improved; individual patient; interest; intervention effect; medical specialties; mortality; novel; personalized care; preservation; psychosocial; randomized trial; resilience; substance abuse treatment; success; therapy development; treatment adherence; treatment services; young adult

Project Abstract The purpose of this study is to conduct a comprehensive and state-of-the-art meta-analysis of Cognitive Behavioral Therapy, Relapse Prevention, and other Cognitive-Behavioral Intervention (CBIs) efficacy, moderated efficacy, and mediating processes. Building upon our prior work (R21 AA026006; PI: Magill, Co-Is: Kiluk & Ray; Consultants: Carroll & Tonigan), this R01 project will extract additional functional endpoints from the prior meta-analytic sample (i.e., K~100 primary studies), will conduct an updated search to yield all recent trials, and will incorporate advanced methodologies such as Network Meta-Analysis (NMA) and Individual Participant Data Meta-Analysis (IPD). In our prior work, consumption frequency and heavy frequency at one early and one late follow-up time point were the a priori indicators of interest. However, the dialogue on what constitutes an optimal endpoint in randomized clinical trials has grown in recent years (e.g., ACTIVE Initiative), arguing that a range of functional endpoints beyond abstinence or heavy consumption should be of greater emphasis in treatment development and clinical outcome research. Alternative endpoints such as related problems, coping behaviors, and mental and general health are certainly of interest to patients, families, and clinical providers. These indicators have additionally become key constructs in the what defines recovery. Preliminary analyses of the sample of trials reviewed in R21 AA026006 show that data for 4 to 50 possible endpoints are available per study, and that approximately 79% of the available data have yet to be collected, analyzed, or reported. In addition, using the methods of R21 AA023662 (PI: Magill), direct data requests for a selection of alcohol use disorder (AUD) studies will be conducted, and a number of relevant PIs have already agreed to meet such requests. In this case, a two-stage IPD will be used to conduct an aggregate path analysis of CBI process, considering putative mechanisms of CBI efficacy. Although R01-level meta-analytic projects have been conducted on a) alcohol pharmacotherapies, b) DUI interventions, c) brief interventions for adolescents/young adults, and d) combined AUD and trauma-related therapies, no such project has been undertaken on CBIs, and this is despite their longevity and centrality in direct patient care for alcohol and other drug use disorders. The proposed project, extracting all available endpoints from the published reports, conducting data requests for AUD trials specifically, and conducting NMA to account for variability in type of contrast condition will inform clinical and methodological recommendations on: 1) CBI implementation and delivery, 2) optimal endpoints for measuring CBI effect, and 3) defining and understanding recovery in the context of evidence-based treatment.

项目摘要 本研究的目的是对认知心理学进行全面的、最先进的元分析， 行为治疗、复发预防和其他认知行为干预（CBIs）的疗效， 适度的功效和中介过程。基于我们之前的工作（R21 AA 026006; PI：马吉尔，Co-Is： Kiluk&Ray; Consultants：卡罗尔& Tonigan），该R 01项目将从 先前的元分析样本（即，K~100项主要研究），将进行更新检索，以获得所有最近的 试验，并将纳入先进的方法，如网络荟萃分析（NMA）和个人 参与者数据荟萃分析（IPD）。在我们之前的工作中，消费频率和重频在一 早期和一个晚期随访时间点是感兴趣的先验指标。然而，对话的内容是什么？ 构成随机临床试验中的最佳终点近年来已经增长（例如，ACTIVE Initiative）， 认为除了禁欲或大量消费之外的一系列功能终点应该更重要， 强调治疗开发和临床结果研究。替代终点，如相关 问题，应对行为，精神和一般健康当然是病人，家属， 临床供应商此外，这些指标已成为定义复苏的关键结构。 对R21 AA 026006中审查的试验样本的初步分析表明，4至50例试验的数据可能 每项研究的终点可用，大约79%的可用数据尚未得到 收集、分析或报告。此外，使用R21 AA 023662（PI：马吉尔）的方法，直接数据 将进行酒精使用障碍（AUD）研究的选择请求，以及一些相关的PI 已经同意满足这些要求。在这种情况下，将使用两级IPD进行聚合 CBI过程的路径分析，考虑CBI疗效的假定机制。虽然R 01级荟萃分析 开展了以下项目：a）酒精药物治疗，B）酒后驾车干预，c）对吸毒者的短期干预， 青少年/年轻人，和d）合并AUD和创伤相关治疗，没有这样的项目 在CBIs上进行，尽管它们在酒精和其他疾病的直接患者护理中具有长寿和中心地位， 药物使用障碍拟议的项目，从已发表的报告中提取所有可用的终点， 特别是针对AUD试验进行数据请求，并进行NMA以说明 对比条件将告知临床和方法学建议：1）CBI实施， 交付，2）测量CBI效果的最佳终点，以及3）在上下文中定义和理解恢复 循证治疗