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

NCT06219642 | Unknown

• 1 other identifier: 2022-034M
• Study Type: interventional
• Target: 90
• 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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Perceived Stress Scale (PSS)

  pre and 10 week post intervention

Study Arms (2)

VR mindfulness intervention

EXPERIMENTAL

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

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 not qualify if:

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

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Cristina Crespo, PhD

CONTACT

+593 99 715 0912; mcrespoa@usfq.edu.ec

Ana F Trueba, PhD

CONTACT

+1 8328686081; atruebayepez@mclean.harvard.edu

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: July 15, 2024
• Study Completion: August 15, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

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)