Meta-analysis of Individual Patient Data for PTSD/AODs

PTSD/AOD 个体患者数据的荟萃分析

• 批准号: 10172799
• 负责人: DENISE AIMEE HIEN
• 金额: $ 43.92万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10172799
• 关键词: Address; Anxiety; Area; Back; Behavior Therapy; Characteristics; Clinical Trials; Cognitive Therapy; Communities; Data; Data Analyses; Discipline; Disease; Drug Use Disorder; Effectiveness; Evidence based treatment; Funding; Goals; Hand; Health; Individual; Inpatients; Leadership; Literature; Measurement; Measures; Mediating; Mediation; Mediator of activation protein; Mental Depression; Meta-Analysis; Methodology; Modeling; Multi-Institutional Clinical Trial; National Institute of Drug Abuse; National Institute on Alcohol Abuse and Alcoholism; Participant; Patient-Focused Outcomes; Patients; Pharmacological Treatment; Pharmacotherapy; Policies; Post-Traumatic Stress Disorders; Prisons; Prognosis; Public Health; Randomized; Randomized Controlled Trials; Recommendation; Research; Research Design; Review Literature; Sample Size; Science; Selection Bias; Severities; Site; Sum; Testing; Trauma; Treatment outcome; Variant; Veterans; Weight; Woman; Work; addiction; alcohol and other drug; base; clinical trial implementation; comorbidity; comparative effectiveness; comparative efficacy; cost; design; implementation science; individual patient; innovation; men; optimal treatments; response; suicide rate; synergism; systematic review; theories; treatment arm; treatment effect; treatment trial; virtual

PROJECT SUMMARY/ABSTRACT Two decades of literature clearly document the wide scope of problems associated with post-traumatic stress disorder (PTSD)/alcohol and other drug use disorder (AOD) comorbidity. Evidence-based treatments, including present-focused trauma therapies, past-focused trauma therapies, and pharmacotherapies paired with trauma-focused (TF) or non-trauma focused (NTF) cognitive-behavioral therapies, are available for comorbid PTSD/AODs. However, the state of the science of PTSD/AOD treatment—based on single and multiple-site randomized controlled trials (RCTs), literature reviews, and meta-analyses—leaves the research community unable to make definitive practice and policy recommendations about (1) comparative effectiveness across PTSD/AOD treatments, (2) optimal treatments for different types of patients (e.g., men vs. women, civilians vs. veterans), and (3) and whether changes in PTSD, anxiety and depression mediate treatment effects on AODs differently depending on treatment type. The proposed study, which we call a virtual multisite clinical trial (VCT), will combine data from 50 PTSD/AOD treatment studies that we currently have in hand (total N = 4544), using three measurement and data analysis frameworks that have emerged across multiple independent disciplines: meta-analysis of individual patient data, integrative data analysis, and propensity score weighting specific to moderation and mediation analysis. Using these frameworks, we propose the following Aims: Aim 1: Develop scale scores of PTSD and AOD severity in the presence of study-level measurement non- invariance. Aim 2: Compare the efficacy of evidence-based treatment models for comorbid PTSD and AODs. Aim 3: Test for potential mediators of treatment effects on AODs across treatment models. Aim 4: Explore individual- and study-level moderators to inform for whom each of the treatment models works best. The project will yield the most definitive recommendations to date regarding optimal treatments for various types of patients across PTSD/AOD treatment settings. Our VCT approach will yield a synergy across PTSD/AOD treatment studies that will be greater than the sum of the constituent RCT parts, in a manner that would be cost- and effort-prohibitive for an analogous 50-site, multiple-treatment-arm RCT.

项目摘要/摘要 二十年的文献清楚地记录了与创伤后有关的广泛问题 应激障碍（PTSD）/酒精和其他药物使用障碍（AOD）合并症。循证治疗， 包括目前以目前为重点的创伤疗法，以前的重点创伤疗法和配对的药物治疗 以创伤为中心（TF）或非创伤（NTF）认知行为疗法可用于 合并PTSD/AOD。但是，PTSD/AOD治疗的科学状态 - 基于单一和 多站点随机对照试验（RCT），文献综述和荟萃分析 - 研究社区无法就（1）比较做出确定的实践和政策建议 PTSD/AOD治疗的有效性，（2）针对不同类型患者的最佳治疗方法（例如，男性 与妇女，平民与退伍军人）和（3）以及PTSD，焦虑和抑郁的变化是否介导 根据治疗类型，对AOD的治疗效果不同。 我们称为虚拟多站点临床试验（VCT）的拟议研究将结合50个数据 我们目前拥有的PTSD/AOD治疗研究（总n = 4544），使用三个测量 数据分析框架已在多个独立学科中出现： 个人患者数据，集成数据分析以及特定于 适度和中介分析。使用这些框架，我们提出以下目的： AIM 1：在存在研究级测量的情况下，开发PTSD和AOD严重程度的量表得分 不变性。 目标2：比较合并症PTSD和AOD的基于证据的治疗模型的效率。 AIM 3：测试对治疗模型对AOD的潜在介质的测试。 目标4：探索个体和学习级的主持人，以告知每个治疗模型谁 效果最好。 该项目将产生有关各种最佳治疗的最明确建议 PTSD/AOD治疗环境中的患者类型。我们的VCT方法将产生协同作用 PTSD/AOD治疗研究将大于组成的RCT部分的总和，以此 对于类似的50个站点多处理的RCT，将是成本和努力的。

项目成果

Brain anatomical covariation patterns linked to binge drinking and age at first full drink.

• DOI: 10.1016/j.nicl.2020.102529
• 发表时间: 2021
• 期刊: NeuroImage. Clinical
• 作者: Zhao Y;Constable RT;Hien D;Chung T;Potenza MN
• 通讯作者: Potenza MN

Measurement nonequivalence of the Clinician-Administered PTSD Scale by race/ethnicity: Implications for quantifying posttraumatic stress disorder severity.

• DOI: 10.1037/pas0000943
• 发表时间: 2020-11
• 期刊: Psychological assessment
• 影响因子: 3.6
• 作者: Ruglass LM;Morgan-López AA;Saavedra LM;Hien DA;Fitzpatrick S;Killeen TK;Back SE;López-Castro T
• 通讯作者: López-Castro T

Putting the Patient Back in Clinical Significance: Moderated Nonlinear Factor Analysis for Estimating Clinically Significant Change in Treatment for Posttraumatic Stress Disorder.

让患者回到临床意义：用于估计创伤后应激障碍治疗的临床显着变化的调节非线性因素分析。

• DOI: 10.1002/jts.22624
• 发表时间: 2021
• 期刊: Journal of traumatic stress
• 影响因子: 3.3
• 作者: Saavedra,LissetteM;Morgan-López,AntonioA;Hien,DeniseA;Killeen,ThereseK;Back,SudieE;Ruglass,LesiaM;Fitzpatrick,Skye;Lopez-Castro,Teresa
• 通讯作者: Lopez-Castro,Teresa

Crossover between diagnostic and empirical categorizations of full and subthreshold PTSD.

完全和亚阈值 PTSD 的诊断和经验分类之间的交叉。

• DOI: 10.1016/j.jad.2020.05.031
• 发表时间: 2020
• 期刊: Journal of affective disorders
• 影响因子: 6.6
• 作者: Morgan-López,AntonioA;Killeen,ThereseK;Saavedra,LissetteM;Hien,DeniseA;Fitzpatrick,Skye;Ruglass,LesiaM;Back,SudieE
• 通讯作者: Back,SudieE

Evaluating treatments for posttraumatic stress disorder, alcohol and other drug use disorders using meta-analysis of individual patient data: Design and methodology of a virtual clinical trial.

• DOI: 10.1016/j.cct.2021.106479
• 发表时间: 2021-06
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: L. Saavedra;A. Morgan-Lopez;D. Hien;T. López-Castro;L. Ruglass;S. Back;S. Fitzpatrick;S. Norman;T. Killeen;Chantel T Ebrahimi;Jessica L Hamblen