Cognitive Behavioral Immersion: A Randomized Control Trial of Peer-Based Coaching in the Metaverse

NCT06418997 | Completed DMC

• 2 other identifiers: UP-23-00491R44MH132202
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Depression, Anxiety

Keywords

Metaverse; virtual reality; cognitive-behavioral; depression; depressive Disorders; mental disorders; skills group

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  The PHQ-9 (Kroenke et al., 2001) is a 9-item self-report measure with strong psychometric properties that mirrors the nine criteria for evaluating whether someone meets criteria for major depressive disorder (MDD) in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV; American Psychiatric Association, 1994). Scores range from 0 to 27, with higher scores indicating great symptom severity.

  Post-treatment (8-weeks) and follow-up (6-months)

Secondary Outcomes (2)

• Generalized Anxiety Disorder Questionnaire (GAD-7)

  Post-treatment (8-weeks) and follow-up (6-months)

• WHO Quality of Life-Brief (QOL)

  Post-treatment (8-weeks) and 1-item version at follow-up (6-months)

Study Arms (3)

CBI-Virtual Reality

ACTIVE COMPARATOR

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.

Behavioral: CBI

CBI-Flat Screen

ACTIVE COMPARATOR

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.

Behavioral: CBI

Delayed-Access Control

NO INTERVENTION

Participants randomized to this arm will be asked not to attend CBI sessions.

Interventions

CBI BEHAVIORAL

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.

CBI-Flat Screen; CBI-Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern California: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (4)

• 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.

  PMID: 33471111 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 40327374 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Depressive Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders

Study Officials

• Iony D Ezawa, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: February 26, 2024
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)