JMIR Publications

ABSTRACT

Background:

The clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, due to the large time burden on healthcare professionals when conducting CBT and the lack of a system for providing CBT, there is currently an inadequate provision of CBT for patients who wish to receive it.

Objective:

This study will evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression.

Methods:

This is a single-center, interventional, exploratory, single-arm, non-randomized, open, pre/post-comparative, feasibility study of an unapproved medical device program (JOLLY GOOD Inc., Teijin Pharma Ltd.) to evaluate the acceptability and preliminary efficacy and safety of the study device. The sample size will be 12 patients. Patients who consent to participate in the study will be screened, and baseline testing will be performed on eligible participants prior to the start of the intervention. In principle, 16 sessions of CBT-VR will be conducted once a week in an outpatient setting. The CBT-VR has been developed in accordance with the six stages and 16 sessions described in the current CBT therapist manual, and the contents of the VR and other components correspond to the themes of each of the 16 sessions. The treatment flow using CBT-VR is similar to that of normal CBT; however, this product replaces a portion of the CBT that is conducted in person by a healthcare professional. Feasibility of CBT-VR will be assessed by testing at baseline, at the end of eight sessions, at the end of 16 sessions, or at treatment discontinuation, and by measuring the time required for testing and medical care during each session and by patient questionnaire. After discontinuation of the intervention, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study. Follow-up evaluations will be performed after 3 and 6 months.

Results:

Inclusion started on November 30, 2022, and data collection is ongoing as of May 2023.

Conclusions:

This study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of implementing CBT-VR for patients with depression. If this study confirms the feasibility of CBT-VR for depression, we intend to proceed to a large-scale validation study. Clinical Trial: Japan Registry of Clinical Trials, ID: jRCTs032220481. Registered November 30, 2022.