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临床试验/NCT06208605
NCT06208605招募中不适用

Innovations in Personalizing Treatment for Eating Disorders Using Idiographic Methods and the Impact of Personalization on Psychological, Physical, and Sociodemographic Outcomes

University of Louisville2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2024年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
320
试验地点
2
主要终点
Eating disorder symptoms

研究概览

简要总结

Eating disorders (EDs) are serious mental illness: someone dies of an ED every 52 minutes. EDs are highly related to a host of negative outcomes, including public health and individual disease burden, medical and psychological comorbidities, and social determinants of health (SDOH). Treatment response for EDs are suboptimal; there are no evidence-based treatment for adults with anorexia nervosa (AN) or Other Specified Feeding or Eating Disorder (OSFED) and only 50% of adults respond to current evidence based treatments. There are no precision treatments, nor any treatments that consider social context, in existence. Personalized treatments for EDs, that consider social contexts, are urgently needed to improve treatment response and minimize the suffering associated with these illnesses. The investigators' overall goal, extending upon their past work, is to create a treatment personalized based on idiographic (or one person) models (termed Transdiagnostic Network Informed Personalized Treatment for EDs; T-NIPT-ED). The investigators will carry out a two-phase study to systematically characterize individual mechanisms of treatment (Phase I: N=900) and then test the efficacy of each treatment module (Phase II: N=240 drawn from Phase I) compared to the current gold-standard treatment (Cognitive Behavioral Therapy Enhanced: CBT-E). The study goals are to (1) characterize the prevalence of T-NIPT-ED precision treatment mechanisms and medical and psychological comorbidities (e.g., obesity; depression), individual disease burden (e.g., disability), SDOH (e.g., food insecurity), and public health outcomes (e.g., service utilization) specific to these mechanisms, (2) identify if personalized target mechanisms improve when matched to evidence-based treatment modules of T-NIPT-ED and (3) test if change in T-NIPT-ED is associated with improved outcomes (vs CBT-E), including ED outcomes, comorbidities, disease burden, and public health outcomes and if these outcomes are moderated by SDOH. These goals will ultimately lead to the very first precision treatment for ED and can be extended to additional psychiatric illnesses. The proposed research uses highly innovative methods; intensive longitudinal data collected with mobile technology is combined with state-of-the art idiographic modeling methods to deliver a virtual, personalized treatment. This proposal integrates assessment of broad (e.g., SDOH; public health burden) and specific (e.g., ED symptoms) outcomes, to ensure that social context can be integrated into personalization. The proposed research has high clinical impact. Ultimately, this proposal will lead directly to the creation and dissemination of an evidence-based individually-personalized treatment for EDs, as well as will serve as an exemplar for precision treatment development across the entire field of psychiatry.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current diagnosis of any active eating disorder except ARFID
  • Ages 18-65

排除标准

  • Active Suicidality
  • Active Mania
  • Active psychosis

结局指标

主要结局

Eating disorder symptoms

时间窗: Up to 18 weeks

Eating Disorder Examination Questionnaire 6.0 (EDE-Q) will be used to measure change in eating disorder symptoms. The EDEQ has a minimum global score of 0 and a maximum global score of 132. Higher scores indicate more severe eating pathology.

Clinical impairment

时间窗: Up to 18 weeks

The Clinical Impairment Assessment (CIA) will be used to measure change in severity of psychosocial impairment. The CIA has a minimum score of 0 and a maximum score of 48, with higher scores indicating higher levels of impairment.

次要结局

  • Psychological comorbidities using Structured Clinical Interview for DSM-5 (SCID-5)(Up to 18 weeks)
  • Medical comorbidities using the Health Utilization and Medical Comorbidities(Up to 18 weeks)
  • Health service utilization using the Health Utilization and Medical Comorbidities(Up to 18 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheri Levinson

Director

University of Louisville

研究点 (2)

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