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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. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

72

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Bruno Porras Garcia, PhD
  • Telefonní číslo: +34 645482240
  • E-mail: bporras@uic.es

Studijní záloha kontaktů

  • Jméno: Patricia Pons, PhD
  • Telefonní číslo: +34 651683193
  • E-mail: ppons@iti.es

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Eating Disorder Symptoms
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Emotion Regulation Strategies
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Universitat Internacional de Catalunya

Spolupracovníci

Ministerio de Ciencia e Innovación, Spain

Vyšetřovatelé

  • Vrchní vyšetřovatel: Bruno Porras García, PhD, Universitat Internacional de Catalunya

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

28. dubna 2026

Primární dokončení (Odhadovaný)

1. března 2027

Dokončení studie (Odhadovaný)

1. září 2027

Termíny zápisu do studia

První předloženo

27. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

27. dubna 2026

První zveřejněno (Aktuální)

4. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PID2023-150702OA-I00

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení 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.

Kritéria přístupu pro sdílení 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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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