- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07703397
VR-Based Behavioral Activation in Adults (VR-Dep)
July 11, 2026 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aydin, Turkey (Türkiye), 09010
- Aydin Adnan Menderes University, Department of Psychology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Other: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Beck Depression Inventory (BDI) Scores
Time Frame: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mehmet Şakiroğlu, Assoc. Prof., Aydin Adnan Menderes University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2024
Primary Completion (Actual)
September 22, 2025
Study Completion (Actual)
November 1, 2025
Study Registration Dates
First Submitted
July 4, 2026
First Submitted That Met QC Criteria
July 11, 2026
First Posted (Actual)
July 14, 2026
Study Record Updates
Last Update Posted (Actual)
July 14, 2026
Last Update Submitted That Met QC Criteria
July 11, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ali.yasin.kafes
- 2023/1-12 31906847/050.04.04-9 (Other Identifier: Aydin Adnan Menderes Univ Social & Human Sci Ethics Comm)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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