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PrevED MR. Improving Emotion Dysregulation Through Mixed Reality Based Dialectical Behavioral Therapy in Adolescents and Young Adults at Risk of Developing Eating Disorders. (PrevED MR)

2026年6月22日 更新者：Universitat Internacional de Catalunya

The aim of this study is to evaluate the feasibility and preliminary effects of PrevED MR, a group-based preventive intervention for adolescents and young adults at risk of developing eating disorders. PrevED MR is based on dialectical behavior therapy skills and uses mixed reality and virtual reality activities to support emotion regulation, mindfulness, distress tolerance, and body-related acceptance.

Participants will be randomly assigned to either the PrevED MR intervention group or a waiting-list control group. The intervention will be delivered over 6 weeks, with two sessions per week, for a total of 12 sessions. Assessments will be conducted at baseline and after the intervention to examine changes in eating disorder symptoms, body image acceptance, emotion regulation strategies, rumination, usability, sense of presence, cybersickness, satisfaction, and adherence.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Eating disorders are serious mental health conditions that often emerge during adolescence and young adulthood. Difficulties in emotion regulation, including rumination, emotional suppression, low emotional acceptance, and limited cognitive flexibility, are relevant processes associated with eating disorder risk and symptom maintenance. Preventive interventions that target emotion regulation skills may help reduce eating disorder risk in young people.

PrevED MR is a mixed reality- and virtual reality-supported preventive intervention designed for adolescents and young adults at risk of developing eating disorders. The intervention is grounded in dialectical behavior therapy skills training and combines psychoeducation, paper-based exercises, group activities, and guided immersive experiences. The program focuses on core skills related to mindfulness, emotion identification, emotion regulation, distress tolerance, acceptance, and non-judgmental body-related exposure.

This study is a pilot randomized controlled trial with two parallel arms: an experimental intervention group and a waiting-list control group. Participants allocated to the experimental group will receive the PrevED MR intervention over 6 weeks, with two sessions per week, for a total of 12 sessions. Sessions will be delivered face-to-face in small groups and supervised by trained mental health professionals. Participants allocated to the waiting-list control group will continue their usual activities during the initial study period and will not receive the intervention before the post-intervention assessment.

The study will recruit Spanish-speaking adolescents and young adults who are at mid-to-high risk of developing eating disorders. Participants will complete baseline and post-intervention assessments. Primary outcomes will focus on eating disorder symptoms and body image acceptance. Secondary outcomes will include emotion regulation strategies, rumination, usability, sense of presence, cybersickness, satisfaction, and adherence. The study will also examine whether intervention effects differ according to age group and gender.

研究类型

介入性

注册 (估计的)

72

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Bruno Porras Garcia, PhD
  • 电话号码：+34 645482240
  • 邮箱：bporras@uic.es

研究联系人备份

  • 姓名：Patricia Pons, PhD
  • 电话号码：+34 651683193
  • 邮箱：ppons@iti.es

学习地点

  • 西班牙
    • Barcelona
      • Barcelona、Barcelona、西班牙、08017
        • 招聘中
        • Universitat Internacional de Catalunya
        • 接触：
          • Bruno Porras, Psycology
          • 电话号码：5240 935 042 000
          • 邮箱：bporras@uic.es
        • 接触：
          • Juliana Rojas Rincón, Psychology
          • 电话号码：663539873
          • 邮箱：jrojasr@uic.es

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Adolescents and young adults aged 13 to 35 years.
  • Spanish-speaking participants who are able to understand the study procedures and complete the assessment instruments.
  • Students recruited from participating schools, universities, or related recruitment settings.
  • Participants at mid-to-high risk of developing eating disorders, as assessed by the Eating Attitudes Test-26 (EAT-26) and selected subscales of the Eating Disorder Inventory-3 (EDI-3).
  • Participants who provide informed consent. For minors, informed consent from a parent or legal guardian will also be required, together with the minor's assent when applicable.

Exclusion Criteria:

  • Current or past self-reported diagnosis of an eating disorder.
  • Current severe psychiatric symptoms or diagnosis that could interfere with participation, including suicidal, manic, or psychotic symptoms.
  • Severe neurodevelopmental disorder, intellectual disability, or other cognitive impairment that could interfere with understanding or completing the study procedures.
  • Physical, motor, or sensory impairment that could interfere with the assessment procedures or the use of the mixed/virtual reality intervention.
  • Current psychological or pharmacological treatment for a mental health disorder delivered on a weekly or biweekly basis.
  • Inability to understand Spanish.
  • Failure to provide informed consent. For minors, lack of parent or legal guardian consent will also be an exclusion criterion.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：PrevED MR Intervention
Participants assigned to this arm will receive the PrevED MR intervention, a 6-week group-based preventive program for adolescents and young adults at risk of developing eating disorders. The intervention includes 12 face-to-face group sessions delivered twice weekly and combines psychoeducation, paper-based exercises, group activities, and guided mixed/virtual reality experiences based on dialectical behavior therapy skills.
行为的：PrevED MR Intervention
PrevED MR is a 6-week group-based preventive intervention for adolescents and young adults at risk of developing eating disorders. The program includes 12 face-to-face group sessions delivered twice weekly and combines psychoeducation, paper-based exercises, group activities, and guided mixed/virtual reality experiences. The intervention is based on dialectical behavior therapy skills and targets mindfulness, emotion identification, emotion regulation, distress tolerance, acceptance, and non-judgmental body-related exposure.
无干预：Waiting-List Control
Participants assigned to this arm will continue their usual activities during the 6-week study period and will not receive the PrevED MR intervention before the post-intervention assessment. They may be offered access to the intervention after completion of the post-intervention assessment.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Eating Disorder Symptoms
大体时间：Baseline and post-intervention, approximately 6 weeks after baseline
Eating disorder symptoms will be assessed using the Eating Attitudes Test-26 and selected subscales of the Eating Disorder Inventory-3. The Eating Attitudes Test-26 total score includes 26 items scored from 0 to 3, with a total score ranging from 0 to 78; higher scores indicate greater eating disorder symptomatology. The Eating Disorder Inventory-3 Drive for Thinness subscale includes 7 items scored from 0 to 5, with a total score ranging from 0 to 35; higher scores indicate a stronger drive for thinness. The Eating Disorder Inventory-3 Body Dissatisfaction subscale includes 10 items scored from 0 to 5, with a total score ranging from 0 to 50; higher scores indicate greater body dissatisfaction. A reduction in scores from baseline to post-intervention indicates improvement.
Baseline and post-intervention, approximately 6 weeks after baseline
Change in Body Image Acceptance
大体时间：Baseline and post-intervention, approximately 6 weeks after baseline
Body image acceptance and body image-related psychological flexibility will be assessed using the Body Image Acceptance and Action Questionnaire. The questionnaire includes 12 items scored from 1 to 7, with a total score ranging from 12 to 84. Higher scores indicate greater body image-related psychological inflexibility and lower body image acceptance. Therefore, a reduction in scores from baseline to post-intervention indicates improvement.
Baseline and post-intervention, approximately 6 weeks after baseline

次要结果测量

结果测量
措施说明
大体时间
Change in Emotion Regulation Strategies
大体时间：Baseline and post-intervention, approximately 6 weeks after baseline
Emotion regulation strategies will be assessed using the Emotion Regulation Questionnaire. The questionnaire includes 10 items scored from 1 to 7, with higher item scores indicating greater agreement with each statement. The Cognitive Reappraisal subscale includes 6 items and ranges from 6 to 42; higher scores indicate greater use of cognitive reappraisal. The Expressive Suppression subscale includes 4 items and ranges from 4 to 28; higher scores indicate greater use of expressive suppression. Higher cognitive reappraisal scores are generally interpreted as a more adaptive emotion regulation strategy, whereas higher expressive suppression scores are generally interpreted as a less adaptive emotion regulation strategy.
Baseline and post-intervention, approximately 6 weeks after baseline
Change in Rumination and Worry
大体时间：Baseline and post-intervention, approximately 6 weeks after baseline
Rumination and worry-related repetitive negative thinking will be assessed using the Penn State Worry Questionnaire. The questionnaire includes 16 items assessing the tendency to worry, using response options ranging from 1 to 5. The total score ranges from 16 to 80, with higher scores indicating higher levels of worry and repetitive negative thinking. Therefore, a reduction in scores from baseline to post-intervention indicates improvement.
Baseline and post-intervention, approximately 6 weeks after baseline
System Usability
大体时间：Post-intervention, approximately 6 weeks after baseline
The System Usability Scale (SUS) is a widely used 10-item self-report questionnaire designed to assess perceived usability of a system, product, or technology. Items are rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree), with scores converted to a 0-100 scale. Higher scores indicate better perceived usability.
Post-intervention, approximately 6 weeks after baseline
Cybersickness Symptoms
大体时间：Baseline and post-intervention, approximately 6 weeks after baseline
The Simulator Sickness Questionnaire (SSQ) is a self-report instrument designed to assess symptoms of motion sickness or discomfort experienced during or after virtual reality exposure. The SSQ consists of 16 items grouped into three subscales: Nausea, Oculomotor, and Disorientation. Participants rate the severity of each symptom on a 4-point Likert scale: 0 (None), 1 (Slight), 2 (Moderate), 3 (Severe). Total and subscale scores are calculated according to standardized formulas, with higher scores indicating greater severity of simulator-induced discomfort.
Baseline and post-intervention, approximately 6 weeks after baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universitat Internacional de Catalunya

合作者

Ministerio de Ciencia e Innovación, Spain

调查人员

  • 首席研究员：Bruno Porras García, PhD、Universitat Internacional de Catalunya

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月28日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年6月25日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PID2023-150702OA-I00

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Deidentified individual participant data underlying the results reported in the main publication may be made available to qualified researchers upon reasonable request, after publication of the main study results. Data sharing will be subject to approval by the principal investigators and, when applicable, by the relevant ethics committee or institutional data protection requirements. Data will be shared only in anonymized form and in accordance with the General Data Protection Regulation and Spanish data protection legislation.

IPD 共享时间框架

Deidentified individual participant data and supporting information may become available after publication of the main study results and may be available for 5 years.

IPD 共享访问标准

Data will be available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the principal investigators. Data sharing will require compliance with applicable ethical, legal, and data protection requirements, and may require a data use agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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