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

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder; Interventional Study; VR
• Intervention / Treatment: Device: VR therapy; Device: VR sham

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Daihui Peng, M.D.,Ph.D.; Phone Number: 18017311136; Email: pdhsh@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR therapy	Device: VR therapy; Participants this group received additional VR therapy , with a total 20 sessions over a period of 4 weeks based on routine treatment.
Placebo Comparator: VR sham	Device: VR 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of Depression	Changes in the total score of HAMD-17 at the end of the study compared to baseline	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Response	A reduction of ≥20% in the total score of HAMD-17 at the end of the 2nd week of treatment compared to baseline	2 weeks
Clinical Response	A reduction of ≥50% in the total score of HAMD-17 compared to baseline; specifically, sustained response is defined as a continuous reduction of ≥50% in the total score of HAMD-17 at the end of the 4th and 8th weeks of treatment compared to baseline	2 months
Clinical Remission	A total score of HAMD-17 ≤7; particularly, complete remission is defined as a total score of HAMD-17 ≤7 at the end of both the 4th and 8th weeks of treatment	2 months
Changes in the Clinical Global Impression Scale	Improvement (CGI-I) and Severity (CGI-S) scores compared to baseline	2 months
Conversion to mania	Change of A Young Mania Rating Scale(YMRS) >13 before and after treatment, and 1 month follow-up	2 months
Changes in Patient Satisfaction Scale	Changes in patients satisfaction scale before and after treatment, and 1 month follow-up	2 months
Change in biological rhythms	Change in Biological Rhythms Interview of Assessment in Neuropsychiatry(BRAIN) Scale before and after treatment, and 1 month follow-up	2 months
Change in Quality of life	Change in quality of life score before and after treatment, and 1 month follow-up	2 months
Intervention Acceptability	Acceptability was assessed by questions, "Rate the VR storyline on a scale of 0 to 5". Acceptability was measured with total score of the scale	2 months
Adverse Events	Change of Treatment Emergent Symptom Scale(TESS)before and after treatment, and 1 month follow-up	2 months

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Nanjing XR-Oasis Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): March 4, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: YYLZ-CTP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The prescription data will not be shared with the public. However, if the intervention is effective, the educational materials will be released to the public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No