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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032220481

Registered date:30/11/2022

Cognitive behavioral therapy using virtual reality for depression

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedMajor Depressive Disoder
Date of first enrollment27/01/2023
Target sample size12
Countries of recruitment
Study typeInterventional
Intervention(s)Participants will be scheduled for 16 weekly sessions using CBT-VR as outpatients.

Outcome(s)

Primary OutcomeChanges in HAMD-17 from baseline to session 16
Secondary Outcome1)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
GenderBoth
Include criteria1)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 criteria1)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

Contact

Public contact
Name Ai Ito
Address 4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8551, Japan. Tokyo Japan 187-8551
Telephone +81-423412711
E-mail ai.ito@ncnp.go.jp
Affiliation National Center of Neurology and Psychiatry Hospital
Scientific contact
Name Shinsuke Kito
Address 4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8551, Japan. Tokyo Japan 187-8551
Telephone +81-423412711
E-mail kito@ncnp.go.jp
Affiliation National Center of Neurology and Psychiatry Hospital