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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04977544

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Phobia	Device: vert Drug: Sertraline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: drug only 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.	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.
Experimental: vert combine with drug 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.	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.

Arm

Intervention/Treatment

Active Comparator: drug only

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.

Drug: Sertraline

Experimental: vert combine with drug

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.

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

Outcome Measures

Primary Outcome Measures

the level of anxiety [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 [3 months]
take the heart rate as a biomarker of fear, the faster heart rate means the participate is more afraid

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Fourth Affiliated Hospital of Zhejiang University Medical College	Yiwu	Zhejiang	China

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04977544

Other Study ID Numbers:

2019232

First Posted:

Jul 27, 2021

Last Update Posted:

Jul 27, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

phobia

Additional relevant MeSH terms:

Anxiety Disorders

Phobia, Social

Sertraline

Study Results

No Results Posted as of Jul 27, 2021