Depression - Major Depressive DisorderVR-DepNCT07703397
VR-Based Behavioral Activation in Adults
A study testing Virtual Reality Behavioral Activation Software in people with Depression - Major Depressive Disorder and Behavioral Activation, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Behavioral Activation, Virtual Reality Therapy
- What is being tested?
- Virtual Reality Behavioral Activation Software
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydin Adnan Menderes University, Department of Psychology
Aydin, 09010
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression - Major Depressive Disorder, Behavioral Activation, Virtual Reality Therapy, Behavioral Inhibition
- Being tested
- Virtual Reality Behavioral Activation Software, Waitlist Control and Psychoeducation
- Keywords
- Depression, Virtual Reality, Behavioural Activation, Behavioural Inhibition, Software Development, F1-LD-F1
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Behavioral Activation SoftwareDevice
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.
Waitlist Control and PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Waitlist Control and Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Pre-test) and Post-test (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start10 Dec 2024
- Primary completion22 Sep 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Şakiroğlu, Assoc. Prof., Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703397
- Sponsor's protocol ID
- ali.yasin.kafes
- Other IDs
- 2023/1-12 31906847/050.04.04-9
- Acronym
- VR-Dep
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural Activation Intervention for Depression in a Virtual Reality Environment: Software Development and Effectiveness Study
- ClinicalTrials.gov ID
- NCT07703397
- Acronym / sponsor ID
- VR-Dep / ali.yasin.kafes
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR Behavioral Activation Group | Experimental | Device: Virtual Reality Behavioral Activation SoftwareParticipants 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. |
| Waitlist Control Group | Other | Behavioral: Waitlist Control and PsychoeducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Behavioral Activation SoftwareA 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. | Device | VR Behavioral Activation Group |
| Waitlist Control and PsychoeducationParticipants 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. | Behavioural | Waitlist Control Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Şakiroğlu, Assoc. Prof. study director
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Behavioral Activation Software in people with Depression - Major Depressive Disorder and Behavioral Activation, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Beck Depression Inventory (BDI) Scores (time frame: Baseline (Pre-test) and Post-test (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.