- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07703397
VR-Based Behavioral Activation in Adults (VR-Dep)
11 juillet 2026 mis à jour par: KTO Karatay University
Behavioural Activation Intervention for Depression in a Virtual Reality Environment: Software Development and Effectiveness Study
Study Overview This study aims to evaluate the effectiveness of a newly developed Virtual Reality (VR) behavioral activation software program for individuals experiencing symptoms of depression.
Behavioral activation is a well-established psychological approach that helps individuals re-engage in positive, rewarding activities to reduce depressive symptoms and improve mood.
By translating this approach into an immersive VR environment using hand-tracking technology, the study explores whether technology-enhanced interventions can make therapy more accessible, engaging, and effective.
What the Study InvolvesParticipants in this study are randomly assigned to one of two groups:VR Behavioral Activation Group (Intervention): Participants in this group receive a structured behavioral activation program delivered entirely within a customized virtual reality environment.
Using advanced hand-tracking technology instead of traditional controllers, participants interact naturally with the virtual world to complete rewarding tasks and activities designed to boost engagement and mood.
Waitlist Control Group: Participants in this group do not receive the VR intervention during the active study period, serving as a comparison baseline to accurately measure the specific effects of the VR software.
However, to ensure ethical standards and support all participants, individuals in this group receive psychological education (psychoeducation) after the data collection phase is fully completed.
Research Goals The primary goal is to determine if the VR-focused behavioral activation program successfully reduces depression severity and enhances overall behavioral activation levels compared to the control group.
Additionally, researchers will evaluate how the intervention influences the body's behavioral approach and inhibition systems, providing insights into the underlying psychological mechanisms of VR-driven therapy.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
This study was conducted to evaluate the effect of a virtual reality-based behavioral activation intervention on reducing depression symptoms.
Considering that depression negatively affects the daily functionality of individuals, an interactive behavioral activation intervention was developed in a virtual reality environment and the effectiveness of this intervention was tested.
A randomized controlled experimental design was used in the study.
The sample consisted of 50 participants with moderate to high levels of depression (experimental group = 25, control group = 25).
The experimental group received a behavioral activation intervention in a virtual reality environment for 4 weeks, while the control group was placed on a waiting list.
The intervention was delivered through virtual reality goggles in the morning.
In the virtual reality environment, participants simulated their morning routines, such as waking up, tidying the room, preparing breakfast, and getting dressed.
Sociodemographic Information Form, Behavioral Inhibition System and Behavioral Activation System Scale, Beck Depression Inventory, Presence Questionnaire, Virtual Reality Application Observation Form and Semi-Structured Interview Form for Virtual Reality Applications were used in the data collection process.
In the data analysis phase, Mixed Design Repeated Measures ANOVA was planned for behavioral activation and behavioral inhibition variables, and F1-LD-F1 design analysis was planned for depression and emotion regulation variables.
Type d'étude
Interventionnel
Inscription (Réel)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Aydin, Turquie (Türkiye), 09010
- Aydin Adnan Menderes University, Department of Psychology
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Being 18 years of age or older.
- Being literate (ability to read and write).
- Providing written informed consent by reading and signing the informed consent form.
- Having a score of 17 or above on the Beck Depression Inventory (BDI).
- Having a score of 41 or below on the Behavioral Activation subscale of the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) Scale.
- Having a score of 21 or above on the Behavioral Inhibition subscale of the Behavioral Inhibition System and Behavioral Activation System (BIS/BAS) Scale.
Exclusion Criteria:
- Having advanced vision problems that impair visual function, such as cataracts.
- Having uncorrected visual impairments, such as color blindness.
- Having any psychiatric or neurological disorder characterized by impaired reality testing.
- Being under 18 years of age.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: VR Behavioral Activation Group
Participants in this group receive a structured behavioral activation program delivered entirely within a customized virtual reality environment using hand-tracking technology to reduce depressive symptoms and enhance behavioral activation.
|
A customized virtual reality (VR) software application developed for Meta Quest hardware, utilizing hand-tracking technology.
The software delivers a structured behavioral activation program designed to treat depressive symptoms by engaging participants in immersive, therapeutic activities.
|
|
Autre: Waitlist Control Group
Participants in this group serve as a comparison baseline and do not receive the VR intervention during the active study period.
After all post-test data collection is completed, they are provided with a psychological education (psychoeducation) program for ethical support.
|
Participants remain on a waitlist during the active implementation phase to serve as a control group.
Upon completion of all post-test data collection, they receive a comprehensive psychological education (psychoeducation) program to ensure ethical treatment standards.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Beck Depression Inventory (BDI) Scores
Délai: Baseline (Pre-test) and Post-test (Week 4)
|
The BDI is a 21-item self-report questionnaire used to measure the severity of depressive symptoms.
Each item is rated on a 4-point scale ranging from 0 to 3. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
|
Baseline (Pre-test) and Post-test (Week 4)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Mehmet Şakiroğlu, Assoc. Prof., Aydin Adnan Menderes University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 décembre 2024
Achèvement primaire (Réel)
22 septembre 2025
Achèvement de l'étude (Réel)
1 novembre 2025
Dates d'inscription aux études
Première soumission
4 juillet 2026
Première soumission répondant aux critères de contrôle qualité
11 juillet 2026
Première publication (Réel)
14 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ali.yasin.kafes
- 2023/1-12 31906847/050.04.04-9 (Autre identifiant: Aydin Adnan Menderes Univ Social & Human Sci Ethics Comm)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .