A Study to Evaluate the Efficacy of VR for Bipolar Disorder

Shanghai Mental Health Center

Status

Enrolling

Conditions

Interventional Study

Bipolar Disorder

Treatments

Device: VR therapy

Device: VR sham

Study type

Interventional

Funder types

Other

Identifiers

NCT06399523

YYLZ-CTP-001

Details and patient eligibility

About

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.

Full 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 1.5% to 6.4% . 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.

Enrollment

48 estimated patients

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

13 years or older
Meet the diagnostic criteria for bipolar disorder - depressive episode in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Able to understand the content of the scale
Certain abilities in expressive, reading, and listening
Total score of >17 on the Hamilton Rating Scale for Depression (HAMD-17)
Inform consent

Exclusion criteria

Poor physical condition unable to participate in the study
Currently or previously diagnosed with other major mental disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition（DSM-5）
Severe or active physical illnesses that interfere with the study treatment
Suicidal or self-harming ideas (defined as a score of >3 on item 3 of the Hamilton Depression Scale-17 suicide scale)
Pregnant or lactating women
Participate in other clinical trials within 1 month
Epilepsy or severe eye diseases