Symptoms of Depression and AnxietyNCT06219642
Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador
A study testing Mindfulness using virtual reality in people with Symptoms of Depression and Anxiety, run by Universidad San Francisco de Quito at 1 site in Ecuador.
Trial summary
The availability of affordable hardware and rapidly growing content that can be freely accessed in the public domain raises the possibility of VR being used across the world globally and, in a very broad range of settings, including low-income populations and middle-income countries. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symptoms of Depression and Anxiety
- What is being tested?
- Mindfulness using virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEcuador
- Study dates
- 15 Mar 2023to 24 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal cognitive functioning or mild cognitive impairment
- Being able to give written consent
- Being a Spanish speaker.
Who cannot join
- Moderate to severe cognitive impairment
- Blindness or severe vision problems
- Deafness or hearing problems, history of dizziness
- Current psychosis or mania.
Trial locations and contacts
1 site in 1 country.
About this study
The availability of affordable hardware and rapidly growing content that can be freely accessed in the public domain raises the possibility of VR being used across the world globally and, in a very broad range of settings, including low-income populations and middle-income countries. The goal of this study is implement a randomized control trial using a low-cost VR mindfulness intervention within older adults in Quito, Ecuador compared. The control group will only receive a check-in phone call.
Read the detailed description
The investigators created a guided mindfulness intervention using low-cost VR (smartphones and Destek V5 headsets) for older adults with anxiety in Quito, Ecuador. This project is a collaboration between the Technology and Aging Lab at McLean Hospital and the Universidad San Francisco de Quito in Ecuador. The investigators aim to recruit 90 older adults with anxiety from various outpatient settings in Quito. Participants will be randomized to either a control group or an intervention group.
The control group will receive weekly phone calls in which they are asked how they are doing over 10 weeks. Participants in the intervention group will receive 10 sessions of mindfulness using VR. The investigators will use the free "Sites in VR" app and select different nature scenes for each session.
The intervention consists of 10 sessions, each lasting 30 minutes. In each session, participants are fitted with a VR headset containing a smartphone running the Sites in VR app. The phone, placed in the viewing compartment of the headset, displays a nature scene chosen by the participant. Once participants have acclimated to the scene and understand how to look around (by moving their heads in different directions), the investigators will read a mindfulness script that includes a guided body scan and instructions to engage participants in experiencing the virtual nature scene using multiple senses.
The Ecuador team was trained by the McLean team on the specifications of the intervention, including reviewing the protocol and resolving any problems encountered during administration. The mindfulness sessions will be recorded with video and audio for quality control and supervision to ensure consistency in implementation.
- Conditions
- Symptoms of Depression and Anxiety
- Being tested
- Mindfulness using virtual reality
- Keywords
- Virtual reality, Mindfulness, Ecuador, older adults
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness using virtual realityBehavioural
In each session, participants will be led through the following mindfulness script while using the VR device here is an abbreviated version with excerpts:
"Look around. Try to bring yourself to the moment you are in. Notice the presence of the scene around you. How does the air feel against your skin?" "How do your feet feel against the ground? Where are you? What do you see?" "Do you hear anything?" "What do you smell? What do you taste? While you stay seated, imagine you are walking." "What body sensations are you experiencing? What thoughts are you having? What emotions are you feeling?" At the end of the intervention, participants are asked questions like, "What did you notice about your thoughts and mood before, during, and after the VR session? Did you notice a change in how your body felt or your emotions? Was there anything difficult or uncomfortable about the experience that you feel comfortable sharing?"
| Study group | Role | What they receive |
|---|---|---|
| VR mindfulness intervention | Experimental | The intervention consists of a total of 10 sessions, each lasting 30 minutes. In each session, the investigators fit participants with a VR headset equipped with a smartphone running the Sites in VR app. The phone, placed in the viewing compartment of the headset, displays a nature scene of the participant's choosing. Once participants have acclimated to the scene and understand how to look around the VR environment (by moving their heads in different directions), the investigators read a mindfulness script that includes a guided body scan and instructions to engage participants in experiencing the virtual reality nature scene using multiple senses. Receives: Behavioral: Mindfulness using virtual reality |
| Phone call check-in | No intervention | Investigators will call patients every week and ask how they are doing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Activation Scale for Depression (BADS)
Behavioral Activation for Depression Scale (BADS), a 25-item self-report measure assessing levels of behavioral activation and avoidance associated with depression. Items are rated on a seven-point Likert scale ranging from 0 (not at all) to 6 (completely). Item scores are summed to obtain a total score ranging from 0 to 150. Higher total scores indicate greater behavioral activation, increased engagement in goal-directed activities, and lower levels of depressive avoidance.
Measured: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
Mindfulness Attention Awareness Scale (MAAS)
The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report measure assessing dispositional mindfulness and attention to present-moment experiences. Items are rated on a 6-point Likert scale and summed to obtain a total score ranging from 15 to 90. Higher scores indicate greater mindfulness and awareness of present-moment experiences.
Measured: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
Geriatric Depression Scale (GDS-15)
Geriatric Depression Scale (GDS-15), a 15-item self-report screening instrument designed for older adults. Items are answered in a dichotomous yes/no format and summed to obtain a total score ranging from 0 to 15, with higher scores indicating greater depressive symptom severity. Scores of 0-4 indicate no depressive symptoms, whereas scores ≥5 suggest the presence of depressive symptomatology.
Measured: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
Generalized Anxiety Disorder (GAD-7)
Generalized Anxiety Disorder Scale (GAD-7) , a seven-item self-report measure assessing the frequency of core symptoms of generalized anxiety disorder during the previous two weeks. Items are rated on a four-point scale ranging from 0 "not at all" to 3 "nearly every day,"- Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 5, 10, and 15 represent mild, moderate, and severe anxiety symptoms, respectively.
Measured: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start15 Mar 2023
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Symptoms of Depression and AnxietyStudies 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
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Francisco de Quito
- Sponsor type
- University, hospital or other
- Collaborators
- Mclean Hospital
- Responsible party
- Principal investigator, Ana F Trueba, Universidad San Francisco de Quito
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219642
- Sponsor's protocol ID
- 2022-034M
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2024
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share analytical plan and outcome, as well as study protocol and informed consent to any researcher that requests it.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador
- ClinicalTrials.gov ID
- NCT06219642
- Acronym / sponsor ID
- 2022-034M
- Conditions
- Symptoms of Depression and Anxiety
- Keywords
- Virtual reality, Mindfulness, Ecuador, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Universidad San Francisco de QuitoUniversity, hospital or other
- Collaborators
- Mclean Hospital
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Posted 21 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The availability of affordable hardware and rapidly growing content that can be freely accessed in the public domain raises the possibility of VR being used across the world globally and, in a very broad range of settings, including low-income populations and middle-income countries. The goal of this study is implement a randomized control trial using a low-cost VR mindfulness intervention within older adults in Quito, Ecuador compared. The control group will only receive a check-in phone call.
Detailed description
The investigators created a guided mindfulness intervention using low-cost VR (smartphones and Destek V5 headsets) for older adults with anxiety in Quito, Ecuador. This project is a collaboration between the Technology and Aging Lab at McLean Hospital and the Universidad San Francisco de Quito in Ecuador. The investigators aim to recruit 90 older adults with anxiety from various outpatient settings in Quito. Participants will be randomized to either a control group or an intervention group.
The control group will receive weekly phone calls in which they are asked how they are doing over 10 weeks. Participants in the intervention group will receive 10 sessions of mindfulness using VR. The investigators will use the free "Sites in VR" app and select different nature scenes for each session.
The intervention consists of 10 sessions, each lasting 30 minutes. In each session, participants are fitted with a VR headset containing a smartphone running the Sites in VR app. The phone, placed in the viewing compartment of the headset, displays a nature scene chosen by the participant. Once participants have acclimated to the scene and understand how to look around (by moving their heads in different directions), the investigators will read a mindfulness script that includes a guided body scan and instructions to engage participants in experiencing the virtual nature scene using multiple senses.
The Ecuador team was trained by the McLean team on the specifications of the intervention, including reviewing the protocol and resolving any problems encountered during administration. The mindfulness sessions will be recorded with video and audio for quality control and supervision to ensure consistency in implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR mindfulness intervention | Experimental | Behavioral: Mindfulness using virtual realityThe intervention consists of a total of 10 sessions, each lasting 30 minutes. In each session, the investigators fit participants with a VR headset equipped with a smartphone running the Sites in VR app. The phone, placed in the viewing compartment of the headset, displays a nature scene of the participant's choosing. Once participants have acclimated to the scene and understand how to look around the VR environment (by moving their heads in different directions), the investigators read a mindfulness script that includes a guided body scan and instructions to engage participants in experiencing the virtual reality nature scene using multiple senses. |
| Phone call check-in | No intervention | –Investigators will call patients every week and ask how they are doing. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal cognitive functioning or mild cognitive impairment
- Being able to give written consent
- Being a Spanish speaker.
Key exclusion criteria (4 listed)
- Moderate to severe cognitive impairment
- Blindness or severe vision problems
- Deafness or hearing problems, history of dizziness
- Current psychosis or mania.
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 |
|---|---|---|
| Mindfulness using virtual realityIn each session, participants will be led through the following mindfulness script while using the VR device here is an abbreviated version with excerpts: "Look around. Try to bring yourself to the moment you are in. Notice the presence of the scene around you. How does the air feel against your skin?" "How do your feet feel against the ground? Where are you? What do you see?" "Do you hear anything?" "What do you smell? What do you taste? While you stay seated, imagine you are walking." "What body sensations are you experiencing? What thoughts are you having? What emotions are you feeling?" At the end of the intervention, participants are asked questions like, "What did you notice about your thoughts and mood before, during, and after the VR session? Did you notice a change in how your body felt or your emotions? Was there anything difficult or uncomfortable about the experience that you feel comfortable sharing?" | Behavioural | VR mindfulness intervention |
Primary outcome
Behavioral Activation Scale for Depression (BADS)
Time frame: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
Behavioral Activation for Depression Scale (BADS), a 25-item self-report measure assessing levels of behavioral activation and avoidance associated with depression. Items are rated on a seven-point Likert scale ranging from 0 (not at all) to 6 (completely). Item scores are summed to obtain a total score ranging from 0 to 150. Higher total scores indicate greater behavioral activation, increased engagement in goal-directed activities, and lower levels of depressive avoidance.
Mindfulness Attention Awareness Scale (MAAS)
Time frame: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report measure assessing dispositional mindfulness and attention to present-moment experiences. Items are rated on a 6-point Likert scale and summed to obtain a total score ranging from 15 to 90. Higher scores indicate greater mindfulness and awareness of present-moment experiences.
Geriatric Depression Scale (GDS-15)
Time frame: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
Geriatric Depression Scale (GDS-15), a 15-item self-report screening instrument designed for older adults. Items are answered in a dichotomous yes/no format and summed to obtain a total score ranging from 0 to 15, with higher scores indicating greater depressive symptom severity. Scores of 0-4 indicate no depressive symptoms, whereas scores ≥5 suggest the presence of depressive symptomatology.
Generalized Anxiety Disorder (GAD-7)
Time frame: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
Generalized Anxiety Disorder Scale (GAD-7) , a seven-item self-report measure assessing the frequency of core symptoms of generalized anxiety disorder during the previous two weeks. Items are rated on a four-point scale ranging from 0 "not at all" to 3 "nearly every day,"- Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 5, 10, and 15 represent mild, moderate, and severe anxiety symptoms, respectively.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We can share analytical plan and outcome, as well as study protocol and informed consent to any researcher that requests it.
Related trials for Symptoms of Depression and Anxiety
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
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 Mindfulness using virtual reality in people with Symptoms of Depression and Anxiety, run by Universidad San Francisco de Quito at 1 site in Ecuador.
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 3 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 21 Aug 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 Ecuador. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Behavioral Activation Scale for Depression (BADS) (time frame: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).). The study lists 4 primary outcomes in all. 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 21 Aug 2026.