Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador

August 20, 2026 updated by: Ana F Trueba, Universidad San Francisco de Quito
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

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

  • Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador
        • Universidad San Francisco de Quito

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

Yes

Description

Inclusion Criteria:

  • Normal cognitive functioning or mild cognitive impairment
  • Being able to give written consent
  • Being a Spanish speaker.

Exclusion Criteria:

  • Moderate to severe cognitive impairment
  • Blindness or severe vision problems
  • Deafness or hearing problems, history of dizziness
  • Current psychosis or mania.

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
No Intervention: Phone call check-in
Investigators will call patients every week and ask how they are doing.
Experimental: VR mindfulness intervention
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

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?"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
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.
Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
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.
Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
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.
Week 10 (Experimental group post-intervention vs. Control group wait-list condition).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale (PSS)
Time Frame: pre and 10 week post intervention
Stress measure
pre and 10 week post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad San Francisco de Quito

Collaborators

Mclean Hospital

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)

March 15, 2023

Primary Completion (Actual)

April 24, 2024

Study Completion (Actual)

April 24, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-034M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We can share analytical plan and outcome, as well as study protocol and informed consent to any researcher that requests it.

IPD Sharing Time Frame

Data will be available during the process of publication if peer-reviewers would like to review it and post publication upon request

IPD Sharing Access Criteria

Data is available upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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.

Subscribe