Cognitive Behavioral Therapy Based on Virtual Reality and Biofeedback Technology

Virtual Reality Exposure Therapy Clinical Trial

— VRET  

Official title:

Cognitive Behavioral Therapy Based on Virtual Reality and Biofeedback Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04107532
• Other study ID #: 2016-KY095
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2019
• Source: Nanjing Medical University
• Contact: Chun Wang, doc.
• Phone: 15850566376
• Email: fm51109[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study recruited 60 patients with Acrophobia and randomly assigned them to the VR treatment group and the imaginary exposure treatment group. Recruitment conditions for Acrophobia: The Acrophobia questionnaire scored more than 45.45 points; Age 18-55 years old; Right-handedness; No psychotherapy or psychiatric medication for six months; Normal vision or corrective vision; Not during pregnancy or lactation. Before the formal treatment, the participants were interviewed, mainly to understand in detail the fear of heights in the subjects, and to tell the subjects the reasons for the fear of heights and the principles of our treatment. After confirming the participants 'intention to participate in the treatment, a heart test was conducted to eliminate heart problems and finally sign an informed consent form. At the end of the interview, pre-tests were performed to collect fear of heights questionnaires, high attitude questionnaires, behavioral avoidance tests, and nuclear magnetic data collection. 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. Visualizing exposure therapy is to achieve the goal of exposure by transforming the five scenes of VR exposure therapy through language and guiding the subjects through the guidance language. Both treatment groups were required to collect scales and nuclear magnetic data before, after and after six months of follow-up. In addition, at the beginning of this treatment program, an experimental study was added to understand the characteristics of eye movement in people with anorexia. By looking at high altitude images, recording their eye movement characteristics and physiological feedback, and rating the anxiety levels of each image, adding to the normal control group, we found a high altitude image that can cause high altitude fear in people with high altitude fear. And lay the foundation for future related research.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1.18-55 years old; 2.The anxiety scale in AQ scored more than 45.45 points ; 3.Meeting the DSM-IV criteria for specific phobia.

Exclusion Criteria:

1. Other current or recent mental disorders, such as post-traumatic stress disorder;

2. Other physical diseases (such as heart disease and epilepsy) that may affect treatment;

3. Pregnancy or lactation;

4. No effect of psychotropic drugs or psychotherapy or prior exposure to heightphobia within 6 months (2013).

Related Conditions & MeSH terms

• Virtual Reality Exposure Therapy

Intervention

Other:
• Virtual Reality Therapy and Imagination Exposure Therapy
Virtual Reality Therapy and Imagination Exposure Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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