RecruitingNot ApplicableNCT06399523

A Study to Evaluate the Efficacy of VR for Bipolar Disorder

A Prospective, Randomized Controlled Clinical Trial to Evaluate the Efficacy of VR for Bipolar Disorder

Sponsor

Shanghai Mental Health Center

Enrollment

48 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Bipolar Disorder VR Interventional Study

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.

Eligibility

Min Age: 13 Years

Inclusion Criteria6

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 Criteria7

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

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Interventions

DEVICEVR therapy

Participants this group received additional VR therapy , with a total 20 sessions over a period of 4 weeks based on routine treatment.

DEVICEVR sham

Participants in this group received additional VR sham(health education videos,a total of 20 health education videos over a period of 4 weeks) under virtual reality conditions on the basis of routine treatment.