JMIR Publications

ABSTRACT

Background:

Depression and anxiety are among the most common mental health concerns globally. Efficacious treatments such as cognitive behavioral therapy exist for such disorders but remain difficult to access and scale. Cognitive Behavioral Immersion (CBI) – a cognitive behavioral skills training intervention delivered by peer coaches in the metaverse – has been developed to address these barriers to care. CBI can be used through a virtual reality (VR) headset or via flat screen devices such as phones, tablets or computers. Pilot data has established the usability of CBI among participants with clinical levels of depression and anxiety. However, more research is needed to determine whether CBI causes decreases in these symptoms, as well as the impact of delivering CBI through VR technology versus flat screen devices.

Objective:

Our primary aim is to conduct a randomized controlled trial to evaluate the efficacy of immersive CBI accessed via VR headset (CBI-VR) compared to a less immersive (but more accessible) CBI condition accessed via flat screen devices (CBI-FS) and each to a delayed access control (DAC).

Methods:

A total of 306 adults experiencing clinical levels of depressive symptoms are being recruited nationally to participate in this trial. Participants will be evenly randomized to one of three conditions: (1) CBI-VR, (2) CBI-FS, and (3) DAC. The CBI program consists of eight weekly 60-minute group sessions led by trained peer coaches who teach cognitive behavioral skills. The acute period of each condition will last eight weeks with a follow-up period of six months. The primary outcome is depressive symptoms, while secondary outcomes are anxiety symptoms and quality of life. These outcomes will be assessed once at baseline, weekly during the course of the intervention, and monthly during follow-up. We will use hierarchical linear models (HLM) to assess differences in the rate of symptom change among conditions. We also will explore prescriptive (cognitive behavioral skills, group alliance, and program engagement), prognostic (demographics, immersion), and potential mechanisms (cognitive change and social support) of response.

Results:

We hypothesize that participants randomized to either CBI group will experience greater symptom improvement than participants randomized to DAC, and that participants randomized to CBI-VR will experience greater symptom improvement than those randomized to CBI-FS. Data collection began in March 2024 and should conclude by September 2025, with first results submitted for publication in 2025.

Conclusions:

This trial will determine if CBI is efficacious as compared to a control condition and whether VR access enhances CBI outcomes. Findings will contribute to the literature on the use of the metaverse and VR to facilitate effective and accessible mental health interventions, particularly for depression. Clinical Trial: https://clinicaltrials.gov/study/NCT06418997