Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder

Phobia Clinical Trial

Official title:

A Randomized Controlled Study of Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04977544
• Other study ID #: 2019232
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: zheng lin, doctor
• Phone: 13606509130
• Email: linzzr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the efficacy of drugs combined with virtual reality exposure therapy in the treatment of phobias compared with single drug treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Exclude other psychiatric diagnosis and treatment history.

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia
• Phobia, Social

Intervention

Device:
• vert
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.

Drug:
• Sertraline
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.

Locations

Country	Name	City	State
China	The Fourth Affiliated Hospital of Zhejiang University Medical College	Yiwu	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	heart rate of the patients	take the heart rate as a biomarker of fear, the faster heart rate means the participate is more afraid	3 months