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

May 13, 2024 updated by: Iony Ezawa, University of Southern California

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

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Iony D Ezawa, PhD
  • Phone Number: (213) 262-9992
  • Email: ezawa@usc.edu

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Recruiting
        • University of Southern California
        • Contact:
          • Iony D Ezawa, PhD
          • Phone Number: 213-262-9992
          • Email: ezawa@usc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.
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 (PHQ-9)
Time Frame: Post-treatment (8-weeks) and follow-up (6-months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generalized Anxiety Disorder Questionnaire (GAD-7)
Time Frame: Post-treatment (8-weeks) and follow-up (6-months)
The GAD-7 (Spitzer et al., 2006) is a 7-item self-report measure with strong psychometric properties based on the diagnostic criteria for Generalized Anxiety Disorder (GAD-7) from the DSM-IV (American Psychiatric Association, 1994). Scores range from 0 to 21, with higher scores indicating great symptom severity.
Post-treatment (8-weeks) and follow-up (6-months)
WHO Quality of Life-Brief (QOL)
Time Frame: Post-treatment (8-weeks) and 1-item version at follow-up (6-months)
The WHO QOL (Whoqol Group, 1998) is a 26-item self-report cross-cultural measure of quality of life within the domains of physical health, psychological health, social relationships, and environment. During the follow-up period, we will transition to using only the first item of the measure assessing overall quality of life. Scores are transformed on a scale from 0 to 100, with higher scores indicating a higher quality of life.
Post-treatment (8-weeks) and 1-item version at follow-up (6-months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Iony D Ezawa, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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