An interventional study of Mindfulness using virtual reality in Symptoms of Depression and Anxiety, sponsored by Universidad San Francisco de Quito. Completed at 1 site in Ecuador. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Universidad San Francisco de Quito · Not applicable, Interventional, and Treatment
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 84 is close to the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Universidad San Francisco de Quito is the lead sponsor of 6 studies on the registry; none are open to participants now.
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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.
Behavioral: Mindfulness using virtual reality
Investigators will call patients every week and ask how they are doing.
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?"
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
Participant recruitment took place between March and November 2023. The intervention began in March 2023 and continued until April 2024 as participants completed the ten-session program and follow-up assessments. Participants were recruited in Quito, Ecuador, through social media announcements and outreach at daytime clubs offering activities for older adults. Recruitment targeted community-dwelling older adults rather than individuals residing in institutional care settings.
| Milestone | Control | VR Intervention |
|---|---|---|
| Started | 42 | 42 |
| Completed | 29 | 35 |
| Not completed | 13 | 7 |
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.
| scores of participants | Control | VR Intervention |
|---|---|---|
| Behavioral Activation Scale for Depression (BADS) | 77 ± 21.9 | 89.9 ± 20.2 |
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.
| scores of participants | Control | VR Intervention |
|---|---|---|
| Mindfulness Attention Awareness Scale (MAAS) | 51.6 ± 13.3 | 60.4 ± 14.2 |
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.
| scores of participants | Control | VR Intervention |
|---|---|---|
| Geriatric Depression Scale (GDS-15) | 5.2 ± 3.4 | 2.5 ± 2.3 |
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.
| scores of participants | Control | VR Intervention |
|---|---|---|
| Generalized Anxiety Disorder (GAD-7) | 9 ± 4 | 9 ± 4 |
Collected over Adverse events were monitored from enrollment through completion of follow-up (up to 20 weeks per participant).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| VR Intervention | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
The population assessed were non-institutionalized older adults aged sixty years or older who had the capacity to give consent and who had minimal cognitive impairment, anxiety, and depressive symptoms.
| Age, Continuous(years) | Control | VR Intervention | Total |
|---|---|---|---|
| Mean | 69.3 ± 7.1 | 70.6 ± 7.0 | 69.9 ± 7.0 |
| Sex: Female, Male(Participants) | Control | VR Intervention | Total |
|---|---|---|---|
| Female | 40 | 34 | 74 |
| Male | 2 | 8 | 10 |
| Race/Ethnicity, Customized(Participants) | Control | VR Intervention | Total |
|---|---|---|---|
| Mestizo | 39 | 38 | 77 |
| white | 3 | 4 | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — We can share analytical plan and outcome, as well as study protocol and informed consent to any researcher that requests it.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available during the process of publication if peer-reviewers would like to review it and post publication upon request
Access criteria: Data is available upon request
Ran from Mar 2023 to primary completion in Apr 2024, 13 months.
Results were first posted in Aug 2026, 2 years 3 months after primary completion.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 13 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Universidad San Francisco de Quito