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

NCT ID: NCT06219642

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-08-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Symptoms of Depression and Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness using virtual reality

Intervention Type 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?"

Phone call check-in

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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?"

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mclean Hospital

OTHER

Sponsor Role collaborator

Universidad San Francisco de Quito

OTHER

Sponsor Role lead

Responsible Party

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Ana F Trueba

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad San Francisco de Quito

Quito, Pichincha, Ecuador

Site Status RECRUITING

Countries

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Ecuador

Central Contacts

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Cristina Crespo, PhD

Role: CONTACT

+593 99 715 0912

Ana F Trueba, PhD

Role: CONTACT

+1 8328686081

Facility Contacts

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Cristina Crespo, PhD

Role: primary

+593 99 715 0912

Ana F Trueba, PhD

Role: backup

+18328686081

Other Identifiers

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2022-034M

Identifier Type: -

Identifier Source: org_study_id

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