Cognitive Behavioral Therapy Based on Virtual Reality and Biofeedback Technology

NCT04107532 | Unknown

• 1 other identifier: 2016-KY095
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The subjects were randomly assigned to VR treatment group and imaginary leak treatment group. In the VR treatment group, there were six VR exposure experiences, ranging from low to high levels of exposure, about 20 minutes each time, twice a week. During the course of treatment, physiological data such as skin electricity, skin temperature, heart rate and blood volume were measured, and the state of the subjects was evaluated more objectively. At the same time, every two minutes, the participants were asked the SUD value and recorded. AQ, ATHQ and BAT were recorded before treatment, after treatment and during the follow-up period of six months. The two groups were treated differently. n addition, at the beginning of this treatment program, an experimental study was added to understand the eye movement characteristics of patients with acrophobia. By viewing a group of high-altitude pictures, recording their eye movement characteristics and physiological feedback data, and scoring the anxiety level of each picture, and joining the normal control group, we can find a group of high-altitude pictures which can cause high-altitude fear in patients with high-altitude fear, and lay a foundation for future related research.

Conditions

Virtual Reality Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• AQ

  There were a total of 20 questions on the anxiety scale in the Acrophobia Questionnaire. Each topic scored 0-6 points. More than 45.45 points were included in the group to assess the differences in scores between the subjects before and after treatment.

  3 weeks

Study Arms (2)

Virtual Reality Therapy for Acrophobia

OTHER

There were a total of 5 treatments in the VR treatment group, followed by cliffs, cliffs, cliffs, single-plank bridges, and high-altitude rescues. The difficulty of the scene increased in turn. The frequency of treatment twice a week, about 30 minutes each time, fills in the motion sickness questionnaire before and after each treatment to understand the safety of VR treatment. In the course of treatment, physiological data such as skin electricity, skin temperature, heart rate, and blood volume were measured, and the state of the subjects was objectively evaluated. At the same time, every two minutes, participants were asked about sud values and recorded.

Other: Virtual Reality Therapy and Imagination Exposure Therapy

Imagination Exposure Therapy for Acrophobia

OTHER

The imaginary exposure treatment program is to convert the five scenes of VR exposure treatment through language, guide the subjects through the guidance language, guide the subjects to expose, and achieve the purpose of adaptation. Both treatment groups were required to collect scales and nuclear magnetic data before, after and after six months of follow-up.

Other: Virtual Reality Therapy and Imagination Exposure Therapy

Interventions

Virtual Reality Therapy and Imagination Exposure Therapy OTHER

Virtual Reality Therapy and Imagination Exposure Therapy

Imagination Exposure Therapy for Acrophobia; Virtual Reality Therapy for Acrophobia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old; 2.The anxiety scale in AQ scored more than 45.45 points ; 3.Meeting the DSM-IV criteria for specific phobia.

You may not qualify if:

• Other current or recent mental disorders, such as post-traumatic stress disorder;
• Other physical diseases (such as heart disease and epilepsy) that may affect treatment;
• Pregnancy or lactation;
• No effect of psychotropic drugs or psychotherapy or prior exposure to heightphobia within 6 months (2013).

Sponsors & Collaborators

• Nanjing Medical University: lead

MeSH Terms

Interventions

Virtual Reality Exposure Therapy

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Chun Wang, doc.

  Nanjing Brain Hospital Nanjing, Jiangsu China

  STUDY CHAIR

Central Study Contacts

Chun Wang, doc.

CONTACT

15850566376; fm51109@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 27, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: September 27, 2019

Record last verified: 2019-09