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
1 other identifier
interventional
72
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2026
CompletedStudy Start
First participant enrolled
April 28, 2026
CompletedFirst Posted
Study publicly available on registry
May 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
May 4, 2026
April 1, 2026
10 months
April 27, 2026
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Eating Disorder Symptoms
Eating disorder symptoms will be assessed using the Eating Attitudes Test-26 (EAT-26) and selected subscales of the Eating Disorder Inventory-3 (EDI-3), including Drive for Thinness and Body Dissatisfaction. Higher scores indicate greater eating disorder symptomatology.
Baseline and post-intervention, approximately 6 weeks after baseline
Change in Body Image Acceptance
Body image acceptance will be assessed using the Body Image Acceptance and Action Questionnaire. Higher scores indicate greater body image-related psychological flexibility and acceptance.
Baseline and post-intervention, approximately 6 weeks after baseline
Secondary Outcomes (4)
Change in Emotion Regulation Strategies
Baseline and post-intervention, approximately 6 weeks after baseline
Change in Rumination and Worry
Baseline and post-intervention, approximately 6 weeks after baseline
System Usability
Post-intervention, approximately 6 weeks after baseline
Cybersickness Symptoms
Post-intervention, approximately 6 weeks after baseline
Study Arms (2)
PrevED MR Intervention
EXPERIMENTALParticipants 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.
Waiting-List Control
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Porras García, PhD
Universitat Internacional de Catalunya
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be masked to group allocation. Participants and intervention facilitators cannot be masked due to the nature of the intervention. Participants will be instructed not to disclose their group assignment or intervention-related activities to outcome assessors during assessments.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2026
First Posted
May 4, 2026
Study Start
April 28, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Deidentified individual participant data and supporting information may become available after publication of the main study results and may be available for 5 years.
- Access Criteria
- 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.
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.