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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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-jud

Первичные конечные точки

• Change in Eating Disorder Symptoms [Срок оценки: Baseline and post-intervention, approximately 6 weeks after baseline]
• Change in Body Image Acceptance [Срок оценки: Baseline and post-intervention, approximately 6 weeks after baseline]

Вторичные конечные точки (4)

• Change in Emotion Regulation Strategies [Срок оценки: Baseline and post-intervention, approximately 6 weeks after baseline]
• Change in Rumination and Worry [Срок оценки: Baseline and post-intervention, approximately 6 weeks after baseline]
• System Usability [Срок оценки: Post-intervention, approximately 6 weeks after baseline]
• Cybersickness Symptoms [Срок оценки: Baseline and post-intervention, approximately 6 weeks after baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Universitat Internacional de Catalunya — Barcelona

Идентификаторы

NCT: NCT07565129 · PID2023-150702OA-I00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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