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

Not Applicable

Recruiting

• Conditions: Symptoms of Depression and Anxiety
• Interventions: Behavioral: Mindfulness using virtual reality

• Registration Number: NCT06219642
• Lead Sponsor: Universidad San Francisco de Quito

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.

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 Timeline

• Study Start: 2023-03-15
• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-07-15
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR mindfulness intervention	Mindfulness using virtual reality	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS)	pre and 10 week post intervention	Stress measure

Trial Locations

Locations (1)

Universidad San Francisco de Quito; 🇪🇨 Quito, Pichincha, Ecuador