Back to resultsVirtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
Primary Purpose
Phobia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vert
Sertraline
Sponsored by
About this trial
This is an interventional treatment trial for Phobia focused on measuring phobia, VR
Eligibility Criteria
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.
Sites / Locations
- The Fourth Affiliated Hospital of Zhejiang University Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
drug only
vert combine with drug
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
heart rate of the patients
take the heart rate as a biomarker of fear, the faster heart rate means the participate is more afraid
Secondary Outcome Measures
Full Information
NCT ID
NCT04977544
First Posted
June 20, 2021
Last Updated
July 25, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04977544
Brief Title
Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
Official Title
A Randomized Controlled Study of Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobia
Keywords
phobia, VR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
drug only
Arm Type
Active Comparator
Arm Description
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 Title
vert combine with drug
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
vert
Intervention Description
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 Type
Drug
Intervention Name(s)
Sertraline
Intervention Description
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.
Primary Outcome Measure Information:
Title
the level of anxiety
Description
the score of Hamilton anxiety scale, the minimum and maximum values are 0 and 56, and higher scores mean a worse outcome.
Time Frame
3 months
Title
heart rate of the patients
Description
take the heart rate as a biomarker of fear, the faster heart rate means the participate is more afraid
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zheng lin, doctor
Phone
13606509130
Email
linzzr@126.com
Facility Information:
Facility Name
The Fourth Affiliated Hospital of Zhejiang University Medical College
City
Yiwu
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yunrong lu
Phone
13757118257
Email
13757118257@163.com
12. IPD Sharing Statement
Learn more about this trial
Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
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