Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
A Randomized Controlled Study of Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
1 other identifier
interventional
200
1 country
1
Brief Summary
To explore the efficacy of drugs combined with virtual reality exposure therapy in the treatment of phobias compared with single drug treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 20, 2021
CompletedFirst Posted
Study publicly available on registry
July 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJuly 27, 2021
June 1, 2021
3 years
June 20, 2021
July 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
drug only
ACTIVE COMPARATORSertraline 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
EXPERIMENTALOn 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Exclude other psychiatric diagnosis and treatment history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fourth Affiliated Hospital of Zhejiang University Medical College
Yiwu, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2021
First Posted
July 27, 2021
Study Start
September 1, 2019
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
July 27, 2021
Record last verified: 2021-06