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Behavioral Intervention
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
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 belowSelect...
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Health Questionnaire (PHQ-9)
Secondary outcome measures
Generalized Anxiety Disorder Questionnaire (GAD-7)
WHO Quality of Life-Brief (QOL)
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.
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,175 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,868 Previous Clinical Trials
2,777,180 Total Patients Enrolled
Iony D Ezawa, PhDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
150 Total Patients Enrolled
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