A Prospective, Randomized Controlled Clinical Trial to Evaluate the Efficacy of VR for Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evolution of Depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evolution of Depression
时间窗: 1 month
Changes in the total score of HAMD-17 at the end of the study compared to baseline
次要结局
- Changes in Patient Satisfaction Scale(2 months)
- Changes in the Clinical Global Impression Scale(2 months)
- Conversion to mania(2 months)
- Change in Quality of life(2 months)
- Intervention Acceptability(2 months)
- Clinical Response(2 months)
- Change in biological rhythms(2 months)
- Adverse Events(2 months)
- Early Response(2 weeks)
- Clinical Remission(2 months)