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

N/ANot Yet RecruitingNCT07565129

Universitat Internacional de Catalunya72 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Eating Disorder Symptoms

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.

Time frame: Baseline and post-intervention, approximately 6 weeks after baseline

Change in Body Image Acceptance

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.

Time frame: Baseline and post-intervention, approximately 6 weeks after baseline

Secondary Outcomes

Change in Emotion Regulation Strategies

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.

Time frame: Baseline and post-intervention, approximately 6 weeks after baseline

Change in Rumination and Worry

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.

Time frame: Baseline and post-intervention, approximately 6 weeks after baseline

System Usability

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.

Time frame: Post-intervention, approximately 6 weeks after baseline

Cybersickness Symptoms

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.

Time frame: Post-intervention, approximately 6 weeks after baseline

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts