Cognitive Behavioral Therapy Based on Virtual Reality and Biofeedback Technology (VRET)

September 25, 2019 updated by: Chun Wang, Nanjing Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Virtual Reality Therapy for Acrophobia
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
Virtual Reality Therapy and Imagination Exposure Therapy
OTHER: Imagination Exposure Therapy for Acrophobia
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
Virtual Reality Therapy and Imagination Exposure Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AQ
Time Frame: 3 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chun Wang, doc., Nanjing Brain Hospital Nanjing, Jiangsu China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-KY095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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