Cognitive behavioral therapy using virtual reality for depression

JRCT ID: jRCTs032220481

Registered date:30/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Major Depressive Disoder
• Date of first enrollment: 27/01/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Participants will be scheduled for 16 weekly sessions using CBT-VR as outpatients.

Outcome(s)

• Primary Outcome: Changes in HAMD-17 from baseline to session 16

Secondary Outcome

1)Adherence to treatment
2)Time of consultation for CBT therapy
3)Usability, satisfaction, and homework compliance
4)Changes in HAMD-17 from baseline to session 8
5)Changes in MADRS, QIDS-SR, EQ-5D-5L, and CGI from baseline to session 8 or 16
6)Rates of remission defined as HAMD-17<=7 or MADRS<=10
7)Rates of response defined as a reduction of 50% or more of HAMD-17 or MADRS
8)Changes in HAMD-17, MADRS, QIDS-SR, EQ-5D-5L, and CGI for the follow-up period.
9)Rates of subjects who achieve a success in reducing psychiatric medications at 3- or 6-month follow-up
10)Adverse events
11)Malfunction

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1)Subjects with a diagnosis of Major Depressive Disorder as defined by DSM-5
2)Subjects with HAMD-17 score >=12 at screening
3)Subjects who have not responded to at least one antidepressant treatment or subjects who are not suitable for antidepressants due to tolerability, comorbidity, pregnancy, or noncompliance of medications
4)Between 18 and 65 years of age
5)Subjects who give full consent in the participation of the study

Exclude criteria

1)History or concurrent manic, hypomanic, or psychotic episode
2)History or concurrent personality disorder or PTSD
3)History or concurrent alcohol or substance use disorder
4)Serious suicidal ideation
5)Subjects who have not responded to CBT
6)Subjects who have any difficulty using the VR device and the mobile application
7)Other relevant reason decided by the investigators

Related Information

• Primary Sponsor: Kito Shinsuke
• Source(s) of Monetary Support: Jolly Good Inc.