Clinical trial NCT06219642: Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador
Official title: Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Symptoms of Depression and Anxiety
Lead sponsor: Universidad San Francisco de Quito
Sponsor class: OTHER
Collaborators: name: Mclean Hospital
First posted: 2024-01-23
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Behavioral Activation Scale for Depression (BADS)
timeFrame: pre and 10 week post intervention
measure: Mindfulness Attention Awareness Scale (MAAS)
timeFrame: pre and 10 week post intervention
measure: Geriatric Depression Scale (GDS-15)
timeFrame: pre and 10 week post intervention
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: pre and 10 week post intervention
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: pre and 10 week post intervention
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: Universidad San Francisco de Quito
state: Pichincha
Study officials:
References: