Symptoms of Depression and Anxiety
Conditions
Keywords
Virtual reality, Mindfulness, Ecuador, older adults
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
The investigators 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. The investigators aim to recruit 90 older adults with anxiety from various outpatient settings in Quito. Participants will be randomized to either a control group or an intervention group. The control group will receive weekly phone calls in which they are asked how they are doing over 10 weeks. Participants in the intervention group will receive 10 sessions of mindfulness using VR. The investigators will use the free "Sites in VR" app and select different nature scenes for each session. The intervention consists of 10 sessions, each lasting 30 minutes. In each session, participants are fitted with a VR headset containing a smartphone running the Sites in VR app. The phone, placed in the viewing compartment of the headset, displays a nature scene chosen by the participant. Once participants have acclimated to the scene and understand how to look around (by moving their heads in different directions), the investigators will read a mindfulness script that includes a guided body scan and instructions to engage participants in experiencing the virtual nature scene using multiple senses. The Ecuador team was trained by the McLean team on the specifications of the intervention, including reviewing the protocol and resolving any problems encountered during administration. The mindfulness sessions will be recorded with video and audio for quality control and supervision to ensure consistency in implementation.
Interventions
BEHAVIORALMindfulness 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?"
Sponsors
Universidad San Francisco de Quito
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Normal cognitive functioning or mild cognitive impairment * Being able to give written consent * Being a Spanish speaker.
Exclusion criteria
* Moderate to severe cognitive impairment * Blindness or severe vision problems * Deafness or hearing problems, history of dizziness * Current psychosis or mania.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Activation Scale for Depression (BADS) | Week 10 (Experimental group post-intervention vs. Control group wait-list condition). | Behavioral Activation for Depression Scale (BADS), a 25-item self-report measure assessing levels of behavioral activation and avoidance associated with depression. Items are rated on a seven-point Likert scale ranging from 0 (not at all) to 6 (completely). Item scores are summed to obtain a total score ranging from 0 to 150. Higher total scores indicate greater behavioral activation, increased engagement in goal-directed activities, and lower levels of depressive avoidance. |
| Mindfulness Attention Awareness Scale (MAAS) | Week 10 (Experimental group post-intervention vs. Control group wait-list condition). | The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report measure assessing dispositional mindfulness and attention to present-moment experiences. Items are rated on a 6-point Likert scale and summed to obtain a total score ranging from 15 to 90. Higher scores indicate greater mindfulness and awareness of present-moment experiences. |
| Geriatric Depression Scale (GDS-15) | Week 10 (Experimental group post-intervention vs. Control group wait-list condition). | Geriatric Depression Scale (GDS-15), a 15-item self-report screening instrument designed for older adults. Items are answered in a dichotomous yes/no format and summed to obtain a total score ranging from 0 to 15, with higher scores indicating greater depressive symptom severity. Scores of 0-4 indicate no depressive symptoms, whereas scores ≥5 suggest the presence of depressive symptomatology. |
| Generalized Anxiety Disorder (GAD-7) | Week 10 (Experimental group post-intervention vs. Control group wait-list condition). | Generalized Anxiety Disorder Scale (GAD-7) , a seven-item self-report measure assessing the frequency of core symptoms of generalized anxiety disorder during the previous two weeks. Items are rated on a four-point scale ranging from 0 "not at all" to 3 "nearly every day,"- Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Scores of 5, 10, and 15 represent mild, moderate, and severe anxiety symptoms, respectively. |
Countries
Ecuador
Participant flow
Recruitment details
Participant recruitment took place between March and November 2023. The intervention began in March 2023 and continued until April 2024 as participants completed the ten-session program and follow-up assessments. Participants were recruited in Quito, Ecuador, through social media announcements and outreach at daytime clubs offering activities for older adults. Recruitment targeted community-dwelling older adults rather than individuals residing in institutional care settings.
Pre-assignment details
A total of 158 individuals initially completed the screening process. Of these, 74 did not meet the inclusion criteria and were excluded from the study. The remaining 84 participants met the eligibility criteria and were enrolled in the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 7.1 |
| Race/Ethnicity, Customized Mestizo | 38 Participants |
| Race/Ethnicity, Customized white | 4 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
None listed