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

NCT06219642 | Completed Results

• 1 other identifier: 2022-034M
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Symptoms of Depression and Anxiety

Keywords

Virtual reality; Mindfulness; Ecuador; older adults

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Week 10 (Experimental group post-intervention vs. Control group wait-list condition).

Study Arms (2)

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.

Behavioral: Mindfulness using virtual reality

Phone call check-in

NO INTERVENTION

Investigators will call patients every week and ask how they are doing.

Interventions

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?"

VR mindfulness intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad San Francisco de Quito: lead
• Mclean Hospital: collaborator

Study Sites (1)

Universidad San Francisco de Quito

Quito, Pichincha, Ecuador

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Limitations and Caveats

The results of this study should be interpreted in light of several limitations. First, the sample did not consist of a clinically acute population. Second, the control condition consisted of phone-based contact, which may not provide a sufficiently rigorous comparison to isolate the additional effects of VR

Results Point of Contact

• Title: Cristina Crespo
• Organization: Universidad San Francisco de Quito

mcrespoa@usfq.edu.ec

593 99 715 0912

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: March 15, 2023
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: August 21, 2026
• Results First Posted: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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

Locations

EC (1)