PhobiaNCT04977544
Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
A study testing vert and Sertraline in people with Phobia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To explore the efficacy of drugs combined with virtual reality exposure therapy in the treatment of phobias compared with single drug treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Phobia
- What is being tested?
- vert and Sertraline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2022
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet the diagnostic criteria for phobias in DSM-IV.
- Age from 18 to 45 years old.
- Graduated from junior high school or above.
- No serious physical disease, no serious visual impairment, and no family history of mental illness.
Who cannot join
- Exclude other psychiatric diagnosis and treatment history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University Medical College
Yiwu, Zhejiang
yunrong lu, 13757118257, 13757118257@163.com
About this study
Official title: A Randomized Controlled Study of Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
To explore the efficacy of drugs combined with virtual reality exposure therapy in the treatment of phobias compared with single drug treatment.
- Conditions
- Phobia
- Being tested
- vert, Sertraline
- Keywords
- phobia, VR
- Medical subject headings
- Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vertDevice
On the basis of sertraline drug treatment, phobia patients were given 2d/times from the 5th week, each 35-45min VR exposure treatment, 15 times as a course of treatment.
SertralineDrug
Sertraline was given as a single drug, with an initial dose of 50 mg/d, and gradually increased to the maximum dose of 200 mg/d after 2 weeks. The treating physician will determine the specific dose adjustment according to the patient's condition.
| Study group | Role | What they receive |
|---|---|---|
| drug only | Active comparator | Sertraline was given as a single drug, with an initial dose of 50 mg/d, and gradually increased to the maximum dose of 200 mg/d after 2 weeks. The treating physician will determine the specific dose adjustment according to the patient's condition. Receives: Drug: Sertraline |
| vert combine with drug | Experimental | On the basis of sertraline drug treatment, phobia patients were given 2d/times from the 5th week, each 35-45min VR exposure treatment, 15 times as a course of treatment. Receives: Device: vert; Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the level of anxiety
the score of Hamilton anxiety scale, the minimum and maximum values are 0 and 56, and higher scores mean a worse outcome.
Measured: 3 months
heart rate of the patients
take the heart rate as a biomarker of fear, the faster heart rate means the participate is more afraid
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Sep 2019
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhobiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977544
- Sponsor's protocol ID
- 2019232
- Status last verified
- Jun 2021
- First submitted
- 20 Jun 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT04977544
- Acronym / sponsor ID
- 2019232
- Conditions
- Phobia
- Keywords
- phobia, VR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 27 Jul 2021 (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.
To explore the efficacy of drugs combined with virtual reality exposure therapy in the treatment of phobias compared with single drug treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug only | Active comparator | Drug: SertralineSertraline was given as a single drug, with an initial dose of 50 mg/d, and gradually increased to the maximum dose of 200 mg/d after 2 weeks. The treating physician will determine the specific dose adjustment according to the patient's condition. |
| vert combine with drug | Experimental | Device: vert, Drug: SertralineOn the basis of sertraline drug treatment, phobia patients were given 2d/times from the 5th week, each 35-45min VR exposure treatment, 15 times as a course of treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for phobias in DSM-IV.
- Age from 18 to 45 years old.
- Graduated from junior high school or above.
- No serious physical disease, no serious visual impairment, and no family history of mental illness.
Key exclusion criteria (1 listed)
- Exclude other psychiatric diagnosis and treatment history.
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 |
|---|---|---|
| vertOn the basis of sertraline drug treatment, phobia patients were given 2d/times from the 5th week, each 35-45min VR exposure treatment, 15 times as a course of treatment. | Device | vert combine with drug |
| SertralineSertraline was given as a single drug, with an initial dose of 50 mg/d, and gradually increased to the maximum dose of 200 mg/d after 2 weeks. The treating physician will determine the specific dose adjustment according to the patient's condition. | Drug | drug only, vert combine with drug |
Primary outcome
the level of anxiety
Time frame: 3 months
the score of Hamilton anxiety scale, the minimum and maximum values are 0 and 56, and higher scores mean a worse outcome.
heart rate of the patients
Time frame: 3 months
take the heart rate as a biomarker of fear, the faster heart rate means the participate is more afraid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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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 vert and Sertraline in people with Phobia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 inclusion and 1 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 27 Jul 2021. 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. 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?
Contact zheng lin, doctor (13606509130, linzzr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the level of anxiety (time frame: 3 months). The study lists 2 primary outcomes in all. 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 27 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.