VR-Based Behavioral Activation in Adults

NCT07703397 | Completed

• 2 other identifiers: ali.yasin.kafes2023/1-12 31906847/050.04.04-9
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Beck Depression Inventory (BDI) Scores

  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)

Study Arms (2)

VR Behavioral Activation Group

EXPERIMENTAL

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.

Device: Virtual Reality Behavioral Activation Software

Waitlist Control Group

OTHER

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.

Behavioral: Waitlist Control and Psychoeducation

Interventions

Virtual Reality Behavioral Activation Software DEVICE

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.

VR Behavioral Activation Group

Waitlist Control and Psychoeducation BEHAVIORAL

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.

Waitlist Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Aydin Adnan Menderes University, Department of Psychology

Aydin, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mehmet Şakiroğlu, Assoc. Prof.

  Aydin Adnan Menderes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 14, 2026
• Study Start: December 10, 2024
• Primary Completion: September 22, 2025
• Study Completion: November 1, 2025
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)