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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)

6 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

72

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Bruno Porras Garcia, PhD
  • Número de telefone: +34 645482240
  • E-mail: bporras@uic.es

Estude backup de contato

  • Nome: Patricia Pons, PhD
  • Número de telefone: +34 651683193
  • E-mail: ppons@iti.es

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Sem intervenção: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Eating Disorder Symptoms
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Emotion Regulation Strategies
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
Post-intervention, approximately 6 weeks after baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Universitat Internacional de Catalunya

Colaboradores

Ministerio de Ciencia e Innovación, Spain

Investigadores

  • Investigador principal: Bruno Porras García, PhD, Universitat Internacional de Catalunya

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

28 de abril de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

27 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de abril de 2026

Primeira postagem (Real)

4 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PID2023-150702OA-I00

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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