Clinical trial NCT06399523: A Study to Evaluate the Efficacy of VR for Bipolar Disorder
Official title: A Prospective, Randomized Controlled Clinical Trial to Evaluate the Efficacy of VR for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
VR
Interventional Study
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Nanjing XR-Oasis Technology Co., Ltd.
First posted: 2024-05-03
Enrollment: 48
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of Depression
timeFrame: 1 month
Secondary outcomes:
measure: Early Response
timeFrame: 2 weeks
measure: Clinical Response
timeFrame: 2 months
measure: Clinical Remission
timeFrame: 2 months
measure: Changes in the Clinical Global Impression Scale
timeFrame: 2 months
measure: Conversion to mania
timeFrame: 2 months
measure: Changes in Patient Satisfaction Scale
timeFrame: 2 months
measure: Change in biological rhythms
timeFrame: 2 months
measure: Change in Quality of life
timeFrame: 2 months
measure: Intervention Acceptability
timeFrame: 2 months
measure: Adverse Events
timeFrame: 2 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References: