Trial Outcomes & Findings for Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador (NCT NCT06219642)
NCT ID: NCT06219642
Last Updated: 2026-08-21
Results Overview
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.
COMPLETED
NA
84 participants
Week 10 (Experimental group post-intervention vs. Control group wait-list condition).
2026-08-21
Participant Flow
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.
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.
Participant milestones
| Measure |
Control
Participants assigned to the control group underwent a 10-week waiting period. During this period, they received a brief weekly phone call to assess their emotional state, physical activity, and eating habits, and to maintain regular contact with the research team. The calls followed a structured script, lasted approximately 10 minutes, and were conducted by the same psychologists who delivered the intervention. During each call, participants' responses were transcribed and recorded in the study documentation. After the waiting period, participants in the control group also received the 10-session VR-assisted mindfulness intervention
|
VR Intervention
Participants assigned to the experimental group received a weekly mindfulness session using virtual reality (VR) goggles for 10 weeks, beginning immediately after the baseline assessment. All sessions were conducted individually, either in participants' homes or in quiet, private spaces in community settings, to minimize interruptions and ensure a comfortable environment for the intervention. The VR experience was delivered using the Sites in VR platform (http://www.sitesinvr.com), which provides immersive 360° environments. Natural landscape scenes available within the platform were used to facilitate the mindfulness exercises
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
29
|
35
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness Intervention Using Virtual Reality in Older Adults With Symptoms of Anxiety and Depression in Ecuador
Baseline characteristics by cohort
| Measure |
Control
n=42 Participants
Participants assigned to the control group underwent a 10-week waiting period. During this period, they received a brief weekly phone call to assess their emotional state, physical activity, and eating habits, and to maintain regular contact with the research team. The calls followed a structured script, lasted approximately 10 minutes, and were conducted by the same psychologists who delivered the intervention. During each call, participants' responses were transcribed and recorded in the study documentation. After the waiting period, participants in the control group also received the 10-session VR-assisted mindfulness intervention.
Average age: 69.3 Race: 39 Mestizo, and 3 White Gender: 40 females
|
VR Intervention
n=42 Participants
Participants assigned to the experimental group received a weekly mindfulness session using virtual reality (VR) goggles for 10 weeks, beginning immediately after the baseline assessment. All sessions were conducted individually, either in participants' homes or in quiet, private spaces in community settings, to minimize interruptions and ensure a comfortable environment for the intervention. The VR experience was delivered using the Sites in VR platform (http://www.sitesinvr.com), which provides immersive 360° environments. Natural landscape scenes available within the platform were used to facilitate the mindfulness exercises.
Average age: 70.6 Race: 38 Mestizo, and 4 White Gender: 34 females
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
70.6 years
STANDARD_DEVIATION 7.0 • n=109 Participants
|
69.9 years
STANDARD_DEVIATION 7.0 • n=133 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
34 Participants
n=109 Participants
|
74 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
8 Participants
n=109 Participants
|
10 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
Mestizo
|
39 Participants
n=5 Participants
|
38 Participants
n=109 Participants
|
77 Participants
n=133 Participants
|
|
Race/Ethnicity, Customized
white
|
3 Participants
n=5 Participants
|
4 Participants
n=109 Participants
|
7 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=37 Participants
Participants assigned to the control group underwent a 10-week waiting period. During this period, they received a brief weekly phone call to assess their emotional state, physical activity, and eating habits, and to maintain regular contact with the research team. The calls followed a structured script, lasted approximately 10 minutes, and were conducted by the same psychologists who delivered the intervention. During each call, participants' responses were transcribed and recorded in the study documentation. After the waiting period, participants in the control group also received the 10-session VR-assisted mindfulness intervention
|
VR Intervention
n=36 Participants
Participants assigned to the experimental group received a weekly mindfulness session using virtual reality (VR) goggles for 10 weeks, beginning immediately after the baseline assessment. All sessions were conducted individually, either in participants' homes or in quiet, private spaces in community settings, to minimize interruptions and ensure a comfortable environment for the intervention. The VR experience was delivered using the Sites in VR platform (http://www.sitesinvr.com), which provides immersive 360° environments. Natural landscape scenes available within the platform were used to facilitate the mindfulness exercises
|
|---|---|---|
|
Behavioral Activation Scale for Depression (BADS)
|
77 scores of participants
Standard Deviation 21.9
|
89.9 scores of participants
Standard Deviation 20.2
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=37 Participants
Participants assigned to the control group underwent a 10-week waiting period. During this period, they received a brief weekly phone call to assess their emotional state, physical activity, and eating habits, and to maintain regular contact with the research team. The calls followed a structured script, lasted approximately 10 minutes, and were conducted by the same psychologists who delivered the intervention. During each call, participants' responses were transcribed and recorded in the study documentation. After the waiting period, participants in the control group also received the 10-session VR-assisted mindfulness intervention
|
VR Intervention
n=36 Participants
Participants assigned to the experimental group received a weekly mindfulness session using virtual reality (VR) goggles for 10 weeks, beginning immediately after the baseline assessment. All sessions were conducted individually, either in participants' homes or in quiet, private spaces in community settings, to minimize interruptions and ensure a comfortable environment for the intervention. The VR experience was delivered using the Sites in VR platform (http://www.sitesinvr.com), which provides immersive 360° environments. Natural landscape scenes available within the platform were used to facilitate the mindfulness exercises
|
|---|---|---|
|
Mindfulness Attention Awareness Scale (MAAS)
|
51.6 scores of participants
Standard Deviation 13.3
|
60.4 scores of participants
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=37 Participants
Participants assigned to the control group underwent a 10-week waiting period. During this period, they received a brief weekly phone call to assess their emotional state, physical activity, and eating habits, and to maintain regular contact with the research team. The calls followed a structured script, lasted approximately 10 minutes, and were conducted by the same psychologists who delivered the intervention. During each call, participants' responses were transcribed and recorded in the study documentation. After the waiting period, participants in the control group also received the 10-session VR-assisted mindfulness intervention
|
VR Intervention
n=36 Participants
Participants assigned to the experimental group received a weekly mindfulness session using virtual reality (VR) goggles for 10 weeks, beginning immediately after the baseline assessment. All sessions were conducted individually, either in participants' homes or in quiet, private spaces in community settings, to minimize interruptions and ensure a comfortable environment for the intervention. The VR experience was delivered using the Sites in VR platform (http://www.sitesinvr.com), which provides immersive 360° environments. Natural landscape scenes available within the platform were used to facilitate the mindfulness exercises
|
|---|---|---|
|
Geriatric Depression Scale (GDS-15)
|
5.2 scores of participants
Standard Deviation 3.4
|
2.5 scores of participants
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control
n=37 Participants
Participants assigned to the control group underwent a 10-week waiting period. During this period, they received a brief weekly phone call to assess their emotional state, physical activity, and eating habits, and to maintain regular contact with the research team. The calls followed a structured script, lasted approximately 10 minutes, and were conducted by the same psychologists who delivered the intervention. During each call, participants' responses were transcribed and recorded in the study documentation. After the waiting period, participants in the control group also received the 10-session VR-assisted mindfulness intervention
|
VR Intervention
n=36 Participants
Participants assigned to the experimental group received a weekly mindfulness session using virtual reality (VR) goggles for 10 weeks, beginning immediately after the baseline assessment. All sessions were conducted individually, either in participants' homes or in quiet, private spaces in community settings, to minimize interruptions and ensure a comfortable environment for the intervention. The VR experience was delivered using the Sites in VR platform (http://www.sitesinvr.com), which provides immersive 360° environments. Natural landscape scenes available within the platform were used to facilitate the mindfulness exercises
|
|---|---|---|
|
Generalized Anxiety Disorder (GAD-7)
|
9 scores of participants
Standard Deviation 4
|
9 scores of participants
Standard Deviation 4
|
Adverse Events
Control
VR Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place