Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418997
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
Cognitive Behavioral Immersion A Randomized Control Trial of Peer-Based Coaching in the Metaverse
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Cognitive Behavioral Immersion A Randomized Control Trial of Peer-Based Coaching in the Metaverse
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test a new cognitive-behavioral skills training program CBI delivered in the metaverse Although initial evidence suggested CBI was feasible for individuals experiencing depression or anxiety CBIs effectiveness compared to no intervention has yet to be determined The intervention may be delivered through virtual reality as well as flat-screen devices such as a computer which may also affect CBIs effectiveness
The study will enroll up to 306 participants with depression One third of the participants will access CBI through virtual reality one third of the participants will access CBI through a flat-screen device and one third of the participants will be asked not to attend CBI sessions for the first 8 weeks of participation of the trial For both CBI conditions treatment will be provided over 8 weeks with a 6-month follow-up period Enrollment will be ongoing and groups will occur simultaneously
Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility They will then receive 8-weeks of treatment Participants will complete brief weekly self-report questionnaires throughout their time in the study
The study will enroll up to 306 participants with depression One third of the participants will access CBI through virtual reality one third of the participants will access CBI through a flat-screen device and one third of the participants will be asked not to attend CBI sessions for the first 8 weeks of participation of the trial For both CBI conditions treatment will be provided over 8 weeks with a 6-month follow-up period Enrollment will be ongoing and groups will occur simultaneously
Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility They will then receive 8-weeks of treatment Participants will complete brief weekly self-report questionnaires throughout their time in the study
Detailed Description:
Cognitive behavioral therapy CBT is one of the most effective tools for the treatment of depression and anxiety Despite its many strengths CBT-based clinical care is often very expensive and difficult to access To address problems of accessibility the field is increasingly utilizing lay therapists also commonly referred to as coaches or peers to provide cognitive behavioral coaching There is also accumulating evidence indicating that technology can be used to deliver affordable and accessible treatments with outcomes comparable to traditional face-to-face psychotherapy treatments Karyotaki et al 2021 In particular the metaverse Internet-connected 3-D virtual environments have also that allow end-users to interact as avatars may be a distinctively powerful medium through which to deliver engaging affordable accessible and scalable mental health interventions In addition the use of social virtual reality VR mental health interventions is relatively unexplored yet the sense of presence being there it provides may be useful to increase immersiveness in a digital intervention or facilitate social interaction in a digital space
Therefore the investigators plan to conduct a randomized controlled trial on CBI in order to investigate its effectiveness among different groups of people and investigate the role immersive VR as opposed to a flat screen may play in predicting outcome measures Upon joining the study participants are asked to complete surveys once a week for 8 weeks and brief monthly follow-up surveys for 6 months If you are randomized to either of the CBI conditions you will also be asked to attend 8 weekly 1-hour sessions through a virtual application from a VR headset or flat-screen depending on your condition This study seeks to address the main following research questions 1 Is CBI efficacious and for whom is it more or less efficacious And 2 Does immersive VR confer any advantage over and above accessing CBI via less immersive flat screen devices
Therefore the investigators plan to conduct a randomized controlled trial on CBI in order to investigate its effectiveness among different groups of people and investigate the role immersive VR as opposed to a flat screen may play in predicting outcome measures Upon joining the study participants are asked to complete surveys once a week for 8 weeks and brief monthly follow-up surveys for 6 months If you are randomized to either of the CBI conditions you will also be asked to attend 8 weekly 1-hour sessions through a virtual application from a VR headset or flat-screen depending on your condition This study seeks to address the main following research questions 1 Is CBI efficacious and for whom is it more or less efficacious And 2 Does immersive VR confer any advantage over and above accessing CBI via less immersive flat screen devices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44MH132202 | NIH | None | httpsreporternihgovquickSearchR44MH132202 |