iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders

iTEST：内省准确性作为精神障碍功能的新目标

• 批准号: 10642405
• 负责人: Colin A. Depp
• 金额: $ 73.81万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-20 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10642405
• 关键词: Address; Adherence; Adult; Area; Attention; Basic Science; Behavior; Clinical; Clinical Trials; Cognition; Cognitive; Cognitive remediation; Compensation; Coupled; Cues; Data; Distal; Dose; Failure; Feedback; Goals; Health Priorities; Individual; Intervention; Investigational Therapies; Maintenance; Measures; Mediating; Mediation; Memory; Mental disorders; Motivation; National Institute of Mental Health; Outcome; Outpatients; Pathway Analysis; Performance; Persons; Phase; Pilot Projects; Process; Psychological Transfer; Psychotic Disorders; Randomized, Controlled Trials; Rehabilitation therapy; Research; Schizoaffective Disorders; Schizophrenia; Self Assessment; Series; Shapes; Site; Specific qualifier value; Symptoms; Task Performances; Technology; Testing; Therapeutic Intervention; Thinking; Time; Training; Translating; Validation; Variant; Work; clinically significant; cognitive capacity; cognitive rehabilitation; cognitive testing; cognitive training; daily functioning; design; digital health; disability; experience; experimental study; follow-up; functional disability; functional improvement; functional outcomes; handheld mobile device; improved; indexing; intervention refinement; mHealth; metacognition; multimodality; novel; pilot test; post intervention; preventive intervention; psychosocial development; randomized trial; recruit; remediation; remote delivery; skills; social cognition; success; usability

PROJECT SUMMARY/ABSTRACT This resubmission responds to PAR-MH-21-135 (Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders, R61/R33), addressing the PAR by sequentially testing a new intervention that is translated from basic science and that uses a multi-modal approach to assessing and modifying an objectively measured target. The overarching goal is to evaluate a new blended mobile intervention that is aimed at improving introspective accuracy (IA) in people with psychotic disorders, with the ultimate goal of improving functional outcome. Introspective accuracy is the degree to which one’s self-assessment of task performance or abilities corresponds with objective data. Our group and others have demonstrated that poor IA is a strong and independent predictor of functional disability. Yet, there are currently no treatments that directly target IA. Basic experimental research and other lines of evidence suggest IA is malleable, and that improvement in task-based IA transfers to untrained tasks. This project’s premise is that task-based IA training could be delivered in a remote mobile health format and coupled with coaching in applying improved IA to real- world functional behaviors, creating a novel avenue for functional rehabilitation in psychotic disorders. We have developed and completed usability testing of iTEST, a novel blended mobile intervention. iTEST integrates graduated drill-and-practice training delivered on a mobile device that targets IA with personalized coaching in applying IA to everyday compensatory behaviors. In the R61 phase, we will recruit people with psychotic disorders with at least minimal functional impairment. We will first conduct a pilot study to finalize a fully ready-for-deployment version of iTEST. Next, we propose an open trial of iTEST, evaluating whether the intervention leads to clinically significant changes in task-based IA along with transfer to an untrained task (target mechanisms). We will also determine the dose of intervention needed to achieve clinically significant improvement in IA targets, by evaluating change at 8, 12, or 16 weeks. If go/no go criteria (clinically significant increases in trained and untreated introspective accuracy) are met in the R61 phase, the R33 phase includes a randomized controlled trial contrasting iTEST with a control condition that provides training in goal setting and cognitive compensation but does not include task-based IA training. We will evaluate whether iTEST leads to greater improvement in IA and functional outcome, whether these improvements are sustained at follow up, and whether increases in IA mediate improvements in functional outcome. This project responds directly to NIMH Strategic Aim 3.1, by evaluating a new intervention that targets functioning by modifying an objectively measured target. Our project also responds to the NIMH Digital Health Priority Area by advancing mobile interventions for cognitive rehabilitation. If effective, iTEST could be integrated with many cognitive training and other rehabilitative interventions to boost impact on functional outcomes.

项目概要/摘要 此重新提交是对 PAR-MH-21-135（心理社会治疗和预防的发展）的回应 精神障碍干预措施，R61/R33），通过顺序测试新干预措施来解决 PAR 它是从基础科学转化而来，并使用多模式方法来评估和修改 客观测量的目标是评估新的混合移动干预措施 旨在提高精神障碍患者的内省准确性（IA），最终目标是 提高功能结果的内省准确性是指一个人对任务的自我评估的程度。 我们的团队和其他人已经证明表现或能力与客观数据相符。 IA 是功能障碍的强有力且独立的预测因子，但目前尚无治疗方法。 基础实验研究和其他证据表明 IA 是可塑的，并且 基于任务的 IA 的改进转移到未经训练的任务 该项目的前提是基于任务的 IA 培训。 可以以远程移动健康格式提供，并结合将改进的 IA 应用到实际中的指导 世界功能行为，为精神障碍的功能康复创造了一条新途径。 开发并完成了 iTEST 的可用性测试，这是一种新型的混合移动干预。 集成了在移动设备上提供的分级演练和实践培训，以个性化的 IA 为目标 指导如何将 IA 应用于日常补偿行为 在 R61 阶段，我们将招募具有以下能力的人员。 我们将首先进行一项试点研究，以最终确定具有至少轻微功能障碍的精神障碍。 接下来，我们建议对 iTEST 进行完全准备部署的版本，以评估是否可以使用。 干预会导致基于任务的 IA 发生临床显着变化，并转移到未经训练的任务 （目标机制）。我们还将确定实现临床意义所需的干预剂量。 通过评估 8、12 或 16 周是否通过标准的变化（临床）来改善 IA 目标。 在 R61 阶段、R33 阶段，经过训练和未经处理的内省准确性显着提高） 包括一项随机对照试验，将 iTEST 与提供目标训练的控制条件进行对比 设置和认知补偿，但不包括基于任务的 IA 培训。 iTEST 会带来 IA 和功能结果的更大改善，无论这些改善是否持续 后续行动，以及 IA 的增加是否会介导功能结果的改善。 直接实现 NIMH 战略目标 3.1，通过评估一项新的干预措施，该干预措施旨在通过修改 我们的项目还通过推进来响应 NIMH 数字健康优先领域。 如果有效，iTEST 可以与许多认知康复的移动干预措施相结合。 培训和其他康复干预措施，以提高对功能结果的影响。