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Clinical Trials/NCT04977544
NCT04977544UnknownNot Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country200 target enrollmentStarted: September 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
the level of anxiety

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Sertraline (Drug)

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.

Intervention: vert (Device)

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.

Intervention: Sertraline (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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