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 这项研究的目的是进行认知的全面和最新的荟萃分析 行为疗法，预防复发和其他认知行为干预（CBIS）疗效， 调节功效和中介过程。在我们先前的工作（R21 AA026006; PI：Magill，Co-IS： Kiluk＆Ray;顾问：Carroll＆Tonigan），此R01项目将从 先前的荟萃分析样本（即K〜100个基本研究）将进行更新的搜索，以产生所有最近的 试验，并将结合高级方法，例如网络荟萃分析（NMA）和个体 参与者数据荟萃分析（IPD）。在我们先前的工作中，消费频率和重频 早期和一个后期的后续时间点是感兴趣的先验指标。但是，关于什么的对话 近年来，在随机临床试验中构成最佳终点（例如，主动倡议）， 认为超出禁欲或大量消费的一系列功能终点应该更大 重点是治疗发展和临床结果研究。诸如相关的替代端点 问题，应对行为以及心理和一般健康肯定对患者，家庭和 临床提供者。这些指标还成为定义恢复的关键结构。 对R21 AA026006中回顾的试验样本的初步分析表明，4至50的数据可能 每项研究都有终点，并且大约79％的可用数据尚未是 收集，分析或报告。另外，使用R21 AA023662（PI：Magill）的方法，直接数据 将进行选择饮酒障碍（AUD）研究的请求，并进行许多相关的PI 已经同意满足此类请求。在这种情况下，将使用两个阶段的IPD进行聚合 CBI过程的路径分析，考虑了CBI功效的假定机制。虽然R01级元分析 已经在a）酒精药物治疗的项目上进行了项目，b）DUI干预措施，c）简短干预措施 青少年/年轻人以及d）与AUD和创伤相关的疗法，没有这样的项目 在CBIS上进行，尽管它们的寿命和中心性在直接患者护理中，但仍在 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端点， 专门进行AUD试验的数据请求，并进行NMA以说明 对比条件将为临床和方法学建议提供：1）CBI实施和 交付，2）测量CBI效应的最佳终点，以及3）定义和理解上下文中的恢复 基于循证的治疗。