JPRN-jRCTs032220481
Active, not recruiting
Phase 1
A feasibility study of cognitive behavioral therapy using virtual reality for depression - CBT-VR
Kito Shinsuke0 sites12 target enrollmentNovember 30, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Major Depressive Disoder
- Sponsor
- Kito Shinsuke
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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