Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399523
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-24
Brief Title:
A Study to Evaluate the Efficacy of VR for Bipolar Disorder
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
A Prospective Randomized Controlled Clinical Trial to Evaluate the Efficacy of VR for Bipolar Disorder
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bipolar disorder is characterized by high morbidity recurrence disability suicide and comorbidity rate which need novel efficient and safe treatment methods and VR has demonstrate its efficacy in mental disease but not few focus on bipolar disorder A prospective single center randomize clinical study therefore would be carried on to evaluate the efficacy of VR for Bipolar Disorder in China
Detailed Description:
Bipolar disorder BD refers to a type of mood disorder that clinically manifests as both manic or hypomanic episodes and depressive episodes Bipolar disorder is characterized by high morbidity recurrence disability suicide and comorbidity rate The first episode often occurs before age 20 with a lifetime morbidity rate ranging from 15 to 64 Patients with bipolar disorder spend significantly more time experiencing depressive episodes than manic or mixed symptoms throughout their lives At the same time depressive episodes can cause severe psycho-social disabilities imposing a heavy economic burden on their families and society
Despite being the first-line recommended treatment for bipolar depression pharmacotherapy still cannot fully meet the clinical needs Some patients do not achieve clinical remission even after receiving adequate and full-course pharmacotherapy Even if clinical remission is achieved many patients still have residual symptoms and those in the maintenance phase still face a high risk of relapse Psychotherapy has been reported to have various benefits such as improving interpersonal communication skills enhancing cohesion and building social support systems and it has been widely used in the treatment of depression Although psychological intervention plays a crucial role in the treatment of bipolar depression its application in reality is still limited One important reason is the shortage of psychological treatment service resources
The application of virtual reality VR technology in the treatment of mental illnesses has overcome the limitations of traditional psychotherapy techniques It provides a safer more controllable and personalized treatment approach enabling patients to experience environments and events more intuitively and vividly This study aims to explore the clinical intervention effects of a mental disorder adjuvant treatment software developed by Nanjing XR-Oasis Technology Co Ltd on patients with bipolar disorder experiencing depressive episodes The technology is based on the theoretical frameworks of cognitive behavioral therapy interpersonal therapy mental health education and Naikan therapy combined with VR technology
Despite being the first-line recommended treatment for bipolar depression pharmacotherapy still cannot fully meet the clinical needs Some patients do not achieve clinical remission even after receiving adequate and full-course pharmacotherapy Even if clinical remission is achieved many patients still have residual symptoms and those in the maintenance phase still face a high risk of relapse Psychotherapy has been reported to have various benefits such as improving interpersonal communication skills enhancing cohesion and building social support systems and it has been widely used in the treatment of depression Although psychological intervention plays a crucial role in the treatment of bipolar depression its application in reality is still limited One important reason is the shortage of psychological treatment service resources
The application of virtual reality VR technology in the treatment of mental illnesses has overcome the limitations of traditional psychotherapy techniques It provides a safer more controllable and personalized treatment approach enabling patients to experience environments and events more intuitively and vividly This study aims to explore the clinical intervention effects of a mental disorder adjuvant treatment software developed by Nanjing XR-Oasis Technology Co Ltd on patients with bipolar disorder experiencing depressive episodes The technology is based on the theoretical frameworks of cognitive behavioral therapy interpersonal therapy mental health education and Naikan therapy combined with VR technology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None