Cognitive Behavioral Immersion for Depression

N/A

Recruiting

Led By Iony D Ezawa, PhD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment (8-weeks) and 1-item version at follow-up (6-months)

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test a new cognitive-behavioral skills training program delivered in a virtual world called the metaverse. The program aims to help individuals with depression. Participants will be divided into three groups

Who is the study for?

This trial is for individuals with depression or anxiety. Participants must complete initial screenings and evaluations to join. They will be divided into three groups: one using virtual reality, another using flat-screen devices like computers for CBI sessions, and a control group without any intervention for the first 8 weeks.

What is being tested?

The study tests a cognitive-behavioral skills training program (CBI) in the metaverse to see if it helps with depression or anxiety. It compares the effectiveness of CBI delivered via virtual reality versus flat-screen devices against no treatment over an 8-week period followed by a 6-month follow-up.

What are the potential side effects?

Since this is a psychological therapy trial conducted in the metaverse, there may not be direct physical side effects; however, participants might experience discomfort with VR technology or increased awareness of emotional issues during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment (8-weeks) and 1-item version at follow-up (6-months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment (8-weeks) and 1-item version at follow-up (6-months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment (8-weeks) and 1-item version at follow-up (6-months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Health Questionnaire (PHQ-9)

Secondary study objectives

Generalized Anxiety Disorder Questionnaire (GAD-7)

WHO Quality of Life-Brief (QOL)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: CBI-Virtual RealityActive Control1 Intervention

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.

Group II: Delayed-Access ControlActive Control1 Intervention

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

Group III: CBI-Flat ScreenActive Control1 Intervention

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.

0 / 1Eligibility criteria met