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VR-Based Behavioral Activation in Adults

Behavioural Activation Intervention for Depression in a Virtual Reality Environment: Software Development and Effectiveness Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07703397
Acronym
VR-Dep
Enrollment
50
Registered
2026-07-14
Start date
2024-12-10
Completion date
2025-11-01
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral Activation, Behavioral Inhibition, Depression - Major Depressive Disorder, Virtual Reality Therapy

Keywords

Depression, Virtual Reality, Behavioural Activation, Behavioural Inhibition, Software Development, F1-LD-F1

Brief summary

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.

Detailed description

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.

Interventions

DEVICEVirtual Reality Behavioral Activation Software

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.

BEHAVIORALWaitlist Control and Psychoeducation

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.

Sponsors

KTO Karatay University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study utilizes a 2-arm parallel-group randomized controlled trial design with a 1:1 allocation ratio. Participants are randomly assigned to either the experimental group (VR Behavioral Activation with hand-tracking technology) or the waitlist control group. The experimental group receives a structured VR-based behavioral activation intervention. The waitlist control group receives no intervention during the active study period but is provided with a full psychoeducation program immediately after the post-test data collection is completed for ethical support.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Beck Depression Inventory (BDI) ScoresBaseline (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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORMehmet Şakiroğlu, Assoc. Prof.

Aydin Adnan Menderes University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026