Anxiety DisordersVR-PADNCT07250971
Virtual Reality-Based Psychotherapeutic and Psychoeducational Intervention for Anxiety and Depression in Children, Adolescents, and Adults
A study testing Virtual Reality-Based Psychotherapeutic Program in people with Anxiety Disorders and Depressive Disorders, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed as a non-pharmacological, interventional clinical research project to evaluate the feasibility, safety, and implementation of virtual reality (VR)-based psychoeducational and psychotherapeutic interventions for individuals with anxiety and/or depression. Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Anxiety Disorders, Depressive Disorders
- What is being tested?
- Virtual Reality-Based Psychotherapeutic Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jul 2025to 15 Sep 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 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of anxiety and/or depression according to DSM-5 criteria, or presence of subthreshold symptoms associated with functional impairment.
- Age between 12 and 25 years.
- No psychopharmacological treatment within the past 12 months.
- Voluntary participation and written informed consent for the virtual reality sessions.
- Sufficient cognitive capacity to understand and engage with VR-based interventions.
- Referred by a qualified mental health professional for non-pharmacological therapy.
Who cannot join
- History of epilepsy, hypertension, or neurological/cardiovascular conditions that contraindicate the use of virtual reality.
- Presence of psychotic disorder or severe cognitive impairment.
- Stent placement in cerebral or cardiac vessels.
- Current or past-year use of psychiatric medication.
- Refusal or inability to tolerate virtual reality exposure.
- Any medical or psychiatric condition that prevents safe participation in VR sessions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydın University, Department of Child and Adolescent Psychiatry
Istanbul
About this study
Official title: Efficacy of Virtual Reality-Based Psychotherapeutic and Psychoeducational Interventions on Anxiety and Depression Symptoms
This study is designed as a non-pharmacological, interventional clinical research project to evaluate the feasibility, safety, and implementation of virtual reality (VR)-based psychoeducational and psychotherapeutic interventions for individuals with anxiety and/or depression. Participants include children, adolescents, and adults who meet DSM-5 diagnostic criteria or present with subthreshold symptoms associated with functional impairment and who decline pharmacological treatment.
A total of 40 participants are planned to receive five weekly individual VR sessions conducted under the supervision of a psychiatrist or clinical psychologist. The VR intervention will be administered using Meta Quest 2 headsets and will include modules focused on relaxation and breathing exercises, exposure-based tasks, coping strategies for anxiety and procrastination, study skills (e.g., Pomodoro technique), sleep hygiene, and psychoeducation about healthy behaviors. Each session will last approximately 20-40 minutes and will be conducted in a controlled clinical environment to ensure participant safety.
Anxiety and depression levels will be assessed before and after the intervention using validated clinical scales, including the Hamilton Depression Rating Scale and the Beck Depression Inventory. Side effects such as dizziness, nausea, and disorientation will be monitored throughout the study. The primary objective is to evaluate feasibility, implementation, and acceptability of VR-based interventions in a clinical mental health setting. Secondary objectives include exploring pre-post changes in anxiety and depression scores and documenting safety and tolerability of the VR intervention.
Read the detailed description
This study is designed as a non-pharmacological, interventional clinical research project to evaluate the feasibility, safety, and implementation of virtual reality (VR)-based psychoeducational and psychotherapeutic interventions for individuals with anxiety and/or depression. Participants include children, adolescents, and adults who meet DSM-5 diagnostic criteria or present with subthreshold symptoms associated with functional impairment and who decline pharmacological treatment.
A total of 40 participants are planned to receive five weekly individual VR sessions conducted under the supervision of a psychiatrist or clinical psychologist. The VR intervention will be administered using Meta Quest 2 headsets and will include modules focused on relaxation and breathing exercises, exposure-based tasks, coping strategies for anxiety and procrastination, study skills (e.g., Pomodoro technique), sleep hygiene, and psychoeducation about healthy behaviors. Each session will last approximately 20-40 minutes and will be conducted in a controlled clinical environment to ensure participant safety.
Anxiety and depression levels will be assessed before and after the intervention using validated clinical scales, including the Hamilton Depression Rating Scale and the Beck Depression Inventory. Side effects such as dizziness, nausea, and disorientation will be monitored throughout the study. The primary objective is to evaluate feasibility, implementation, and acceptability of VR-based interventions in a clinical mental health setting. Secondary objectives include exploring pre-post changes in anxiety and depression scores and documenting safety and tolerability of the VR intervention.
- Conditions
- Anxiety Disorders, Depressive Disorders
- Being tested
- Virtual Reality-Based Psychotherapeutic Program
- Keywords
- Virtual Reality, Psychotherapy, Psychoeducation, Non-Pharmacological Treatment, Mental Health, Adolescents, Depression, Anxiety, Digital Therapeutics, Immersive Therapy
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Psychotherapeutic ProgramBehavioural
A behavioral intervention delivered through virtual reality (VR) technology designed to reduce symptoms of anxiety and depression. The program included immersive psychoeducational and psychotherapeutic content focusing on relaxation, exposure, coping skills, and healthy routines. Each participant completed five supervised weekly sessions using Meta Quest 2 headsets.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Based Psychotherapeutic and Psychoeducational Intervention | Experimental | All participants received a virtual reality (VR)-based psychotherapeutic and psychoeducational program consisting of five weekly individual sessions lasting 20-40 minutes each. The intervention included modules on relaxation and breathing exercises, exposure, coping strategies, study skills, and sleep hygiene. Sessions were delivered using Meta Quest 2 headsets under professional supervision. Receives: Behavioral: Virtual Reality-Based Psychotherapeutic Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Severity Measured by Hamilton Depression Rating Scale (HAM-D)
Depression severity will be measured using the Hamilton Depression Rating Scale (HAM-D) before and after completion of the five-session VR intervention. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. A decrease in total score represents clinical improvement.
Measured: Baseline and Week 5 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start9 Jul 2025
- Primary completion15 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received the same virtual reality (VR)-based psychotherapeutic and psychoeducational intervention consisting of five weekly sessions. Each session included relaxation, exposure, coping skills, and psychoeducation modules delivered through Meta Quest 2 headsets under professional supervision. There were no control or comparison groups. A pre-test-post-test design was used to measure changes in anxiety and depression symptoms before and after the VR intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağlar Charles Daniel Jaicks, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250971
- Sponsor's protocol ID
- IAU-VR-160-2025
- Other IDs
- 160/2025
- Acronym
- VR-PAD
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and ethical considerations involving sensitive mental health information.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality-Based Psychotherapeutic and Psychoeducational Interventions on Anxiety and Depression Symptoms
- ClinicalTrials.gov ID
- NCT07250971
- Acronym / sponsor ID
- VR-PAD / IAU-VR-160-2025
- Conditions
- Anxiety Disorders, Depressive Disorders
- Keywords
- Virtual Reality, Psychotherapy, Psychoeducation, Non-Pharmacological Treatment, Mental Health, Adolescents, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 26 Nov 2025 (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.
This study is designed as a non-pharmacological, interventional clinical research project to evaluate the feasibility, safety, and implementation of virtual reality (VR)-based psychoeducational and psychotherapeutic interventions for individuals with anxiety and/or depression. Participants include children, adolescents, and adults who meet DSM-5 diagnostic criteria or present with subthreshold symptoms associated with functional impairment and who decline pharmacological treatment.
A total of 40 participants are planned to receive five weekly individual VR sessions conducted under the supervision of a psychiatrist or clinical psychologist. The VR intervention will be administered using Meta Quest 2 headsets and will include modules focused on relaxation and breathing exercises, exposure-based tasks, coping strategies for anxiety and procrastination, study skills (e.g., Pomodoro technique), sleep hygiene, and psychoeducation about healthy behaviors. Each session will last approximately 20-40 minutes and will be conducted in a controlled clinical environment to ensure participant safety.
Anxiety and depression levels will be assessed before and after the intervention using validated clinical scales, including the Hamilton Depression Rating Scale and the Beck Depression Inventory. Side effects such as dizziness, nausea, and disorientation will be monitored throughout the study. The primary objective is to evaluate feasibility, implementation, and acceptability of VR-based interventions in a clinical mental health setting. Secondary objectives include exploring pre-post changes in anxiety and depression scores and documenting safety and tolerability of the VR intervention.
Detailed description
This study is designed as a non-pharmacological, interventional clinical research project to evaluate the feasibility, safety, and implementation of virtual reality (VR)-based psychoeducational and psychotherapeutic interventions for individuals with anxiety and/or depression. Participants include children, adolescents, and adults who meet DSM-5 diagnostic criteria or present with subthreshold symptoms associated with functional impairment and who decline pharmacological treatment.
A total of 40 participants are planned to receive five weekly individual VR sessions conducted under the supervision of a psychiatrist or clinical psychologist. The VR intervention will be administered using Meta Quest 2 headsets and will include modules focused on relaxation and breathing exercises, exposure-based tasks, coping strategies for anxiety and procrastination, study skills (e.g., Pomodoro technique), sleep hygiene, and psychoeducation about healthy behaviors. Each session will last approximately 20-40 minutes and will be conducted in a controlled clinical environment to ensure participant safety.
Anxiety and depression levels will be assessed before and after the intervention using validated clinical scales, including the Hamilton Depression Rating Scale and the Beck Depression Inventory. Side effects such as dizziness, nausea, and disorientation will be monitored throughout the study. The primary objective is to evaluate feasibility, implementation, and acceptability of VR-based interventions in a clinical mental health setting. Secondary objectives include exploring pre-post changes in anxiety and depression scores and documenting safety and tolerability of the VR intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received the same virtual reality (VR)-based psychotherapeutic and psychoeducational intervention consisting of five weekly sessions. Each session included relaxation, exposure, coping skills, and psychoeducation modules delivered through Meta Quest 2 headsets under professional supervision. There were no control or comparison groups. A pre-test-post-test design was used to measure changes in anxiety and depression symptoms before and after the VR intervention.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Based Psychotherapeutic and Psychoeducational Intervention | Experimental | Behavioral: Virtual Reality-Based Psychotherapeutic ProgramAll participants received a virtual reality (VR)-based psychotherapeutic and psychoeducational program consisting of five weekly individual sessions lasting 20-40 minutes each. The intervention included modules on relaxation and breathing exercises, exposure, coping strategies, study skills, and sleep hygiene. Sessions were delivered using Meta Quest 2 headsets under professional supervision. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosis of anxiety and/or depression according to DSM-5 criteria, or presence of subthreshold symptoms associated with functional impairment.
- Age between 12 and 25 years.
- No psychopharmacological treatment within the past 12 months.
- Voluntary participation and written informed consent for the virtual reality sessions.
- Sufficient cognitive capacity to understand and engage with VR-based interventions.
Key exclusion criteria (6 listed)
- History of epilepsy, hypertension, or neurological/cardiovascular conditions that contraindicate the use of virtual reality.
- Presence of psychotic disorder or severe cognitive impairment.
- Stent placement in cerebral or cardiac vessels.
- Current or past-year use of psychiatric medication.
- Refusal or inability to tolerate virtual reality exposure.
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-Based Psychotherapeutic ProgramA behavioral intervention delivered through virtual reality (VR) technology designed to reduce symptoms of anxiety and depression. The program included immersive psychoeducational and psychotherapeutic content focusing on relaxation, exposure, coping skills, and healthy routines. Each participant completed five supervised weekly sessions using Meta Quest 2 headsets. | Behavioural | Virtual Reality-Based Psychotherapeutic and Psychoeducational Intervention |
Primary outcome
Change in Depression Severity Measured by Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline and Week 5 (end of intervention)
Depression severity will be measured using the Hamilton Depression Rating Scale (HAM-D) before and after completion of the five-session VR intervention. The total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. A decrease in total score represents clinical improvement.
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 26 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and ethical considerations involving sensitive mental health information.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-Based Psychotherapeutic Program in people with Anxiety Disorders and Depressive Disorders, run by Istanbul Aydın 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 6 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 26 Nov 2025. 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 in Depression Severity Measured by Hamilton Depression Rating Scale (HAM-D) (time frame: Baseline and Week 5 (end of intervention)). 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 26 Nov 2025.