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.

Study Overview

• Status: Recruiting
• Conditions: Symptoms of Depression and Anxiety
• Intervention / Treatment: Behavioral: Mindfulness using virtual reality

Detailed Description

We 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. Our goal is to recruit 90 older adults with anxiety from various outpatient settings in Quito. They will be randomized to control or to the intervention group. The control group gets a phone call in which they are asked how they are doing during 10 weeks. Those in the intervention group will receive 10 sessions of mindfulness using VR. We will use the free "Sites in VR" app and select different nature scenes for each intervention. The intervention consists of a total of 10 sessions each lasting 30 minutes. In each session, we fit participants with the VR headset with a smartphone running the Sites for VR app. The phone, placed in the viewing compartment of the headset, shows a nature scene of the participant's choosing. Once participants have acclimated to the scene and understand how to look around the VR scene (by moving their heads in different directions), we will read a mindfulness script with a guided body scan and instructions to engage participants through experiencing the virtual reality nature scene with all senses. The Ecuador team was trained by the McLean Team on the specifications of the intervention, to review the protocol, and to resolve any problems encountered during the administration of the intervention. The mindfulness sessions will be recorded with video and audio for quality control and intervention supervision to ensure that there is consistency in how the intervention is implemented.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Crespo, PhD; Phone Number: +593 99 715 0912; Email: mcrespoa@usfq.edu.ec
• Study Contact Backup: Name: Ana F Trueba, PhD; Phone Number: +1 8328686081; Email: atruebayepez@mclean.harvard.edu

Study Locations

• Ecuador
  • Pichincha
    • Quito, Pichincha, Ecuador
      • Recruiting
      • Universidad San Francisco de Quito
      • Contact: Cristina Crespo, PhD; Phone Number: +593 99 715 0912; Email: mcrespoa@usfq.edu.ec
      • Contact: Ana F Trueba, PhD; Phone Number: +18328686081; Email: atruebayepez@mclean.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Normal cognitive functioning or mild cognitive impairment determined using the Montreal Cognitive Assessment (MoCA), being able to give written consent, and being a Spanish speaker. Exclusion criteria were

Exclusion Criteria:

• moderate to severe cognitive impairment, blindness or severe vision problems, deafness or hearing problems, history of dizziness, and current psychosis or mania.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR mindfulness intervention; The intervention consists of a total of 10 sessions each lasting 30 minutes. In each session, we fit participants with the VR headset with a smartphone running the Sites for VR app. The phone, placed in the viewing compartment of the headset, shows a nature scene of the participant's choosing. Once participants have acclimated to the scene and understand how to look around the VR scene (by moving their heads in different directions), we will read a mindfulness script with a guided body scan and instructions to engage participants through experiencing the virtual reality nature scene with all 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?"
No Intervention: Phone call check-in; Investigators will call patients every week and ask how they are doing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Activation Scale for Depression (BADS)	Overall behavior activation	pre and 10 week post intervention
Mindfulness Attention Awareness Scale (MAAS)	Mindfulness skills and state	pre and 10 week post intervention
Geriatric Depression Scale (GDS-15)	depression symptoms	pre and 10 week post intervention
Generalized Anxiety Disorder (GAD-7)	Anxiety symptoms	pre and 10 week post intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad San Francisco de Quito
• Collaborators: Mclean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): August 15, 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): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• 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