iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders
iTEST: Introspective Accuracy as a Novel Target for Functioning in Psychotic Disorders
批准号:
10642405
负责人:
Colin A. Depp
金额:
$73.81万
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-06-20 至 2025-04-30
关键词:
AddressAdherenceAdultAreaAttentionBasic ScienceBehaviorClinicalClinical TrialsCognitionCognitiveCognitive remediationCompensationCoupledCuesDataDistalDoseFailureFeedbackGoalsHealth PrioritiesIndividualInterventionInvestigational TherapiesMaintenanceMeasuresMediatingMediationMemoryMental disordersMotivationNational Institute of Mental HealthOutcomeOutpatientsPathway AnalysisPerformancePersonsPhasePilot ProjectsProcessPsychological TransferPsychotic DisordersRandomized, Controlled TrialsRehabilitation therapyResearchSchizoaffective DisordersSchizophreniaSelf AssessmentSeriesShapesSiteSpecific qualifier valueSymptomsTask PerformancesTechnologyTestingTherapeutic InterventionThinkingTimeTrainingTranslatingValidationVariantWorkclinically significantcognitive capacitycognitive rehabilitationcognitive testingcognitive trainingdaily functioningdesigndigital healthdisabilityexperienceexperimental studyfollow-upfunctional disabilityfunctional improvementfunctional outcomeshandheld mobile deviceimprovedindexingintervention refinementmHealthmetacognitionmultimodalitynovelpilot testpost interventionpreventive interventionpsychosocial developmentrandomized trialrecruitremediationremote deliveryskillssocial cognitionsuccessusability
中文摘要
项目总结/摘要
本次重新提交是对PAR-MH-21-135(心理社会治疗和预防
精神障碍的干预措施,R61/R33),通过顺序测试新的干预措施来解决PAR
这是从基础科学翻译,并使用多模式的方法来评估和修改一个
客观衡量的目标。总体目标是评估一种新的混合移动的干预,
旨在提高精神障碍患者的内省准确性(IA),最终目标是
改善功能结果。内省的准确性是一个人对任务的自我评估的程度
表现或能力与客观数据相对应。我们的团队和其他人已经证明,
IA是功能障碍的一个强有力的独立预测因子。然而,目前还没有治疗方法,
直接瞄准IA基础实验研究和其他证据表明,IA是可塑性的,
改进基于任务的IA转移到未经训练的任务。本项目的前提是,基于任务的IA培训
可以以远程移动的健康形式提供,并结合指导将改进的IA应用于真实的-
世界功能行为,创造了一个新的途径,精神障碍的功能康复。我们
开发并完成了iTEST的可用性测试,iTEST是一种新型的混合移动的干预。ITEST
整合了在移动终端上提供的分级演练和实践培训,
指导将IA应用于日常补偿行为。在R61阶段,我们将招募
至少有轻微功能障碍的精神障碍。我们会先进行试验研究,
iTEST的完全可部署版本。接下来,我们提出了一个开放的试验iTEST,评估是否
干预导致基于任务的IA沿着临床显著变化,并转移到未经训练的任务
(目标机制)。我们还将确定达到临床显著性所需的干预剂量
通过评估第8、12或16周时的变化,改善IA目标。如果通过/不通过标准(临床上
在R61阶段、R33阶段和R34阶段,
包括一项随机对照试验,将iTEST与提供目标训练的对照条件进行对比,
设置和认知补偿,但不包括基于任务的IA培训。我们将评估是否
iTEST导致IA和功能结局的更大改善,无论这些改善是否持续
以及IA的增加是否介导了功能结局的改善。该项目响应
直接向NIMH战略目标3.1,通过评估一个新的干预措施,目标是通过修改一个
客观衡量的目标。我们的项目还通过推进NIMH数字健康优先领域,
移动的认知康复干预。如果有效的话,iTEST可以与许多认知测试相结合,
培训和其他康复干预措施,以提高对功能结果的影响。
英文摘要
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.
期刊论文(0)
专著(0)
科研奖励(0)
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海外基金