Trial Outcomes & Findings for Cognitive Behavioral Immersion: A Randomized Control Trial of Peer-Based Coaching in the Metaverse (NCT NCT06418997)
NCT ID: NCT06418997
Last Updated: 2026-09-03
Results Overview
The Patient Health Questionnaire is a 9-item self-report measure of depression symptom severity. Scores range from 0 to 27, with higher scale scores indicating greater depression symptom severity. Scale scores were assessed and are presented for post-intervention week 8.
COMPLETED
NA
306 participants
post-intervention week 8
2026-09-03
Participant Flow
Participants were recruited through posts on clinical trial registries, advertisements on social media apps, lab websites, and word of mouth. Participants were recruited from February 2024 to January 2025. The first intervention groups (8 weeks in duration) began in March 2024, and the final groups ended in March 2025 when the prespecified sample size was reached. Follow-up data (6 months in duration) were collected from May 2024 to September 2025.
Participant milestones
| Measure |
CBI-Virtual Reality
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a virtual reality headset.
|
CBI-Flat Screen
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills and habits that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a flat-screen device, such as a computer.
|
Delayed-Access Control
Participants randomized to this arm asked not to attend CBI sessions for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
102
|
|
Overall Study
COMPLETED
|
66
|
66
|
88
|
|
Overall Study
NOT COMPLETED
|
36
|
36
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Behavioral Immersion: A Randomized Control Trial of Peer-Based Coaching in the Metaverse
Baseline characteristics by cohort
| Measure |
CBI-Virtual Reality
n=102 Participants
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a virtual reality headset.
|
CBI-Flat Screen
n=102 Participants
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills and habits that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a flat-screen device, such as a computer.
|
Delayed-Access Control
n=102 Participants
Participants randomized to this arm asked not to attend CBI sessions for 8 weeks.
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.39 Years
STANDARD_DEVIATION 12.10 • n=136 Participants
|
37.65 Years
STANDARD_DEVIATION 13.38 • n=136 Participants
|
36.90 Years
STANDARD_DEVIATION 11.67 • n=272 Participants
|
37.31 Years
STANDARD_DEVIATION 12.34 • n=60 Participants
|
|
Sex/Gender, Customized
Female
|
71 Participants
n=136 Participants
|
64 Participants
n=136 Participants
|
74 Participants
n=272 Participants
|
209 Participants
n=60 Participants
|
|
Sex/Gender, Customized
Male
|
31 Participants
n=136 Participants
|
37 Participants
n=136 Participants
|
28 Participants
n=272 Participants
|
96 Participants
n=60 Participants
|
|
Sex/Gender, Customized
Not reported
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=136 Participants
|
27 Participants
n=136 Participants
|
23 Participants
n=272 Participants
|
62 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Black
|
26 Participants
n=136 Participants
|
19 Participants
n=136 Participants
|
28 Participants
n=272 Participants
|
73 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 Participants
n=136 Participants
|
27 Participants
n=136 Participants
|
16 Participants
n=272 Participants
|
62 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Native American
|
2 Participants
n=136 Participants
|
7 Participants
n=136 Participants
|
6 Participants
n=272 Participants
|
15 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
5 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
59 Participants
n=136 Participants
|
51 Participants
n=136 Participants
|
46 Participants
n=272 Participants
|
156 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
6 Participants
n=272 Participants
|
11 Participants
n=60 Participants
|
|
Patient Health Questionnaire-9
|
16.86 scores on a scale
STANDARD_DEVIATION 5.00 • n=136 Participants
|
16.27 scores on a scale
STANDARD_DEVIATION 4.36 • n=136 Participants
|
15.93 scores on a scale
STANDARD_DEVIATION 4.96 • n=272 Participants
|
16.35 scores on a scale
STANDARD_DEVIATION 4.78 • n=60 Participants
|
|
Generalized Anxiety Disorder-7
|
13.10 scores on a scale
STANDARD_DEVIATION 4.85 • n=136 Participants
|
12.98 scores on a scale
STANDARD_DEVIATION 4.86 • n=136 Participants
|
13.18 scores on a scale
STANDARD_DEVIATION 5.06 • n=272 Participants
|
13.09 scores on a scale
STANDARD_DEVIATION 4.91 • n=60 Participants
|
|
World Health Organization Quality of Life - General scale
|
51.96 scores on a scale
STANDARD_DEVIATION 19.49 • n=136 Participants
|
55.88 scores on a scale
STANDARD_DEVIATION 22.02 • n=136 Participants
|
52.94 scores on a scale
STANDARD_DEVIATION 22.05 • n=272 Participants
|
53.59 scores on a scale
STANDARD_DEVIATION 21.22 • n=60 Participants
|
PRIMARY outcome
Timeframe: post-intervention week 8Population: N=4 randomized to CBI-VR and N=16 randomized to CBI-FS completed 0 surveys during the intervention and follow-up periods, and therefore were not included in the primary analyses.
The Patient Health Questionnaire is a 9-item self-report measure of depression symptom severity. Scores range from 0 to 27, with higher scale scores indicating greater depression symptom severity. Scale scores were assessed and are presented for post-intervention week 8.
Outcome measures
| Measure |
CBI-Virtual Reality
n=98 Participants
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a virtual reality headset.
|
CBI-Flat Screen
n=86 Participants
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills and habits that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a flat-screen device, such as a computer.
|
Delayed-Access Control
n=102 Participants
Participants randomized to this arm asked not to attend CBI sessions for 8 weeks.
|
|---|---|---|---|
|
Patient Health Questionnaire-9
|
8.94 scores on a scale
Standard Deviation 0.54
|
10.11 scores on a scale
Standard Deviation 0.57
|
11.25 scores on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: post-intervention week 8Population: N=4 randomized to CBI-VR and N=16 randomized to CBI-FS completed 0 surveys during the intervention and follow-up periods, and therefore were not included in the primary analyses.
The Generalized Anxiety Disorder-7 is a 7-item self-report measure of anxiety symptom severity. Scores range from 0 to 21, with higher scale scores indicating greater anxiety symptom severity. Scale scores were assessed and are presented for post-intervention week 8.
Outcome measures
| Measure |
CBI-Virtual Reality
n=98 Participants
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a virtual reality headset.
|
CBI-Flat Screen
n=86 Participants
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills and habits that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a flat-screen device, such as a computer.
|
Delayed-Access Control
n=102 Participants
Participants randomized to this arm asked not to attend CBI sessions for 8 weeks.
|
|---|---|---|---|
|
Generalized Anxiety Disorder-7
|
7.27 scores on a scale
Standard Deviation 0.51
|
8.73 scores on a scale
Standard Deviation 0.54
|
9.23 scores on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: post-intervention week 8Population: N=4 randomized to CBI-VR and N=16 randomized to CBI-FS completed 0 surveys during the intervention and follow-up periods, and therefore were not included in the primary analyses.
The World Health Organization Quality of Life - General scale is a 1-item self-report scale of general quality of life. Scores on this scale range from 0 to 100. Higher scores on this scale reflect a higher general quality of life. Scale scores were assessed and are presented for post-intervention week 8.
Outcome measures
| Measure |
CBI-Virtual Reality
n=98 Participants
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a virtual reality headset.
|
CBI-Flat Screen
n=86 Participants
Over 8 weekly 1-hour sessions, participants learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills and habits that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm access these sessions using a flat-screen device, such as a computer.
|
Delayed-Access Control
n=102 Participants
Participants randomized to this arm asked not to attend CBI sessions for 8 weeks.
|
|---|---|---|---|
|
World Health Organization Quality of Life-General Scale
|
66.51 scores on a scale
Standard Deviation 1.52
|
64.43 scores on a scale
Standard Deviation 1.56
|
57.58 scores on a scale
Standard Deviation 1.38
|
Adverse Events
CBI-Virtual Reality
CBI-Flat Screen
Delayed-Access Control
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