Cognitive Behavioral Immersion: A Randomized Control Trial of Peer-Based Coaching in the Metaverse
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, CBI's 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 CBI's 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.
Study Overview
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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90089
- University of Southern California
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- Proficient in reading and speaking English
- Have a computer with a stable internet connection
- Score at or above the clinical threshold on the Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001)
Exclusion Criteria:
- Sufficiently elevated levels of negative thoughts such that the individual is considered at high risk of harm, according to the Columbia Suicide Severity Rating Scale (CSSRS)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: CBI-Virtual Reality
Over 8 weekly 1-hour sessions, participants will 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 will access these sessions using a virtual reality headset.
|
CBI sessions follow a detailed manual to teach a group of peers cognitive and behavioral strategies that they may utilize in their daily lives, often based around the cognitive-behavioral model as a teaching tool.
CBI aims to develop cognitive-behaviorally-based skills and habits in participants, such as behavioral activation, mood tracking, the identification and reframing of automatic thoughts, and assertion training.
|
|
Active Comparator: CBI-Flat Screen
Over 8 weekly 1-hour sessions, participants will 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 will access these sessions using a flat-screen device, such as a computer.
|
CBI sessions follow a detailed manual to teach a group of peers cognitive and behavioral strategies that they may utilize in their daily lives, often based around the cognitive-behavioral model as a teaching tool.
CBI aims to develop cognitive-behaviorally-based skills and habits in participants, such as behavioral activation, mood tracking, the identification and reframing of automatic thoughts, and assertion training.
|
|
No Intervention: Delayed-Access Control
Participants randomized to this arm will be asked not to attend CBI sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-9
Time Frame: post-intervention week 8
|
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.
|
post-intervention week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder-7
Time Frame: post-intervention week 8
|
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.
|
post-intervention week 8
|
|
World Health Organization Quality of Life-General Scale
Time Frame: post-intervention week 8
|
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.
|
post-intervention week 8
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Iony D Ezawa, PhD, University of Southern California
Publications and helpful links
General Publications
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration; Riper H, Patel V, Mira A, Gemmil AW, Yeung AS, Lange A, Williams AD, Mackinnon A, Geraedts A, van Straten A, Meyer B, Bjorkelund C, Knaevelsrud C, Beevers CG, Botella C, Strunk DR, Mohr DC, Ebert DD, Kessler D, Richards D, Littlewood E, Forsell E, Feng F, Wang F, Andersson G, Hadjistavropoulos H, Christensen H, Ezawa ID, Choi I, Rosso IM, Klein JP, Shumake J, Garcia-Campayo J, Milgrom J, Smith J, Montero-Marin J, Newby JM, Breton-Lopez J, Schneider J, Vernmark K, Bucker L, Sheeber LB, Warmerdam L, Farrer L, Heinrich M, Huibers MJH, Kivi M, Kraepelien M, Forand NR, Pugh N, Lindefors N, Lintvedt O, Zagorscak P, Carlbring P, Phillips R, Johansson R, Kessler RC, Brabyn S, Perini S, Rauch SL, Gilbody S, Moritz S, Berger T, Pop V, Kaldo V, Spek V, Forsell Y. Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis. JAMA Psychiatry. 2021 Apr 1;78(4):361-371. doi: 10.1001/jamapsychiatry.2020.4364.
- Robinson N, Ramos FN, Hollon SD, Han GT, Ezawa ID. Cognitive Behavioral Immersion for Depression: Protocol for a Three-Arm Randomized Controlled Trial of Peer-Based Coaching in the Metaverse. JMIR Res Protoc. 2025 May 6;14:e65970. doi: 10.2196/65970.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-23-00491
- R44MH132202 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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