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

NCT06418997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2025-12-15

No results posted yet for this study

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

Interventions

BEHAVIORAL

CBI

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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Iony D Ezawa, PhD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2025-09-24
Completion
2025-09-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418997 on ClinicalTrials.gov