Evaluating virtual reality therapy for bipolar disorder
A Prospective, Randomized Controlled Clinical Trial to Evaluate the Efficacy of VR for Bipolar Disorder
This study is testing if virtual reality therapy can help people with bipolar disorder feel better during their depressive episodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06399523 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of virtual reality (VR) therapy in treating patients with bipolar disorder, particularly during depressive episodes. It will be a prospective, single-center, randomized clinical trial conducted at the Shanghai Mental Health Center in China. Participants aged 13 and older who meet the diagnostic criteria for bipolar disorder will be enrolled, and they will receive either VR therapy or a VR sham intervention. The study seeks to address the limitations of current pharmacotherapy and psychotherapy options for bipolar disorder.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 13 years or older who have been diagnosed with a depressive episode of bipolar disorder.
Not a fit: Patients with severe physical illnesses, other major mental disorders, or those exhibiting suicidal tendencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel and effective treatment option for patients suffering from bipolar disorder.
How similar studies have performed: While VR has shown efficacy in treating various mental health conditions, its application specifically for bipolar disorder is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai
- Shanghai Mental Health Center — Shanghai, Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.