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临床试验/NCT05920720
NCT05920720已完成不适用

Personalizing Disordered Eating Treatment Using Mobile Technology: Self-Guided, Personalized Treatment for Women

University of Louisville2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Clinical Impairment

研究概览

简要总结

The investigators plan to collect preliminary data on the feasibility, acceptability, and user uptake of a personalized self-guided mobile intervention for disordered eating (DE) and test the initial clinical efficacy of this intervention. Women (N=50) who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones. The investigators will assess engagement with the modules throughout two months and administer baseline, week 5, and week 8 assessments for acceptability, uptake, and initial clinical efficacy (e.g., DE symptoms, anxiety, quality of life). The investigators will also complete a focus group (n=10) with a subset of users to receive input on the mobile-application assessment and ease of self-guided intervention modules.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Endorse disordered eating (score of 2.3 or above on EDE-Q6)
  • Age 18-65
  • Ability to read and write English
  • Own a smartphone or tablet

排除标准

  • Active mania
  • Active suicidality
  • Active psychosis

研究组 & 干预措施

Self-guided Personalized Treatment

Experimental

Women who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones.

干预措施: Self-guided Personalized Treatment (Behavioral)

结局指标

主要结局

Clinical Impairment

时间窗: Up to 8 weeks

Changes in clinical impairment will be assessed with the Clinical Impairment Assessment (CIA)

Anxiety

时间窗: Up to 8 weeks

Changes in anxiety will be assessed with the Penn State Worry Questionnaire (PSWQ)

Depression

时间窗: Up to 8 weeks

Changes in depression will be assessed with the Beck Depression Inventory-2 (BDI-2)

Disordered eating symptoms

时间窗: Up to 8 weeks

Changes in disordered eating symptoms will be assessed with the Eating Disorder Examination Questionnaire-6 (EDE-Q6)

Quality of life

时间窗: Up to 8 weeks

Changes in quality of life will be assessed with the Quality of Life Scale (QOLS)

次要结局

  • Quality of life(Up to 8 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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