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OpenTrials
Completed

NCT Number: NCT06219642

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

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.

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Key information

Conditions

Symptoms of Depression and Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad San Francisco de Quito

Quito, Pichincha, Ecuador

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness using virtual reality

Behavioral

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?"

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Universidad San Francisco de Quito

Other

Collaborators

  • Mclean Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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