Bipolar DisorderNCT06399523
A Study to Evaluate the Efficacy of VR for Bipolar Disorder
A study testing VR therapy in people with Bipolar Disorder and VR, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Bipolar Disorder, VR, Interventional Study
- What is being tested?
- VR therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 4 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Daihui Peng, M.D.,Ph.D., 18017311136, pdhsh@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bipolar Disorder, VR, Interventional Study
- Being tested
- VR therapy, VR sham
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR therapyDevice
Participants this group received additional VR therapy , with a total 20 sessions over a period of 4 weeks based on routine treatment.
VR shamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VR therapy | Experimental | Not described Receives: Device: VR therapy |
| VR sham | Placebo comparator | Not described Receives: Device: VR sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of Depression
Changes in the total score of HAMD-17 at the end of the study compared to baseline
Measured: 1 month
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 2 months
Changes in the Clinical Global Impression Scale
Improvement (CGI-I) and Severity (CGI-S) scores compared to baseline
Measured: 2 months
Conversion to mania
Change of A Young Mania Rating Scale(YMRS) >13 before and after treatment, and 1 month follow-up
Measured: 2 months
Changes in Patient Satisfaction Scale
Changes in patients satisfaction scale before and after treatment, and 1 month follow-up
Measured: 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
Measured: 2 months
Change in Quality of life
Change in quality of life score before and after treatment, and 1 month follow-up
Measured: 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
Measured: 2 months
Adverse Events
Change of Treatment Emergent Symptom Scale(TESS)before and after treatment, and 1 month follow-up
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start4 Mar 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion4 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing XR-Oasis Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399523
- Sponsor's protocol ID
- YYLZ-CTP-001
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Clinical Trial to Evaluate the Efficacy of VR for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06399523
- Acronym / sponsor ID
- YYLZ-CTP-001
- Conditions
- Bipolar Disorder, VR, Interventional Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Nanjing XR-Oasis Technology Co., Ltd.
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 4 Mar 2025 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR therapy | Experimental | Device: VR therapy |
| VR sham | Placebo comparator | Device: VR sham |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR therapyParticipants this group received additional VR therapy , with a total 20 sessions over a period of 4 weeks based on routine treatment. | Device | VR therapy |
| VR shamParticipants 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. | Device | VR sham |
Primary outcome
Evolution of Depression
Time frame: 1 month
Changes in the total score of HAMD-17 at the end of the study compared to baseline
10 secondary outcomes
Early Response
Time frame: 2 weeks
Clinical Response
Time frame: 2 months
Clinical Remission
Time frame: 2 months
Changes in the Clinical Global Impression Scale
Time frame: 2 months
Conversion to mania
Time frame: 2 months
Changes in Patient Satisfaction Scale
Time frame: 2 months
Change in biological rhythms
Time frame: 2 months
Change in Quality of life
Time frame: 2 months
Intervention Acceptability
Time frame: 2 months
Adverse Events
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR therapy in people with Bipolar Disorder and VR, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of Depression (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.