CClinicalTrials.gg
Status unknownNCT04107532VRETUpdated Sep 27, 2019

Cognitive Behavioral Therapy Based on Virtual Reality and Biofeedback Technology

An interventional study of Virtual Reality Therapy and Imagination Exposure Therapy in Virtual Reality Exposure Therapy, sponsored by Nanjing Medical University. Status unknown. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Virtual Reality Exposure Therapy
03

In context

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherVirtual Reality Therapy and Imagination Exposure Therapy

    Virtual Reality Therapy and Imagination Exposure Therapy

06

What researchers measure

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.

    Time frame: 3 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04107532
Lead sponsor
Nanjing Medical University
Responsible party
Chun Wang (associate chief physician, Nanjing Medical University) — Principal investigator
First posted
Sep 27, 2019
Start date
Oct 1, 2019 (estimated)
Primary completion
Oct 1, 2019 (estimated)
Completion
Oct 1, 2020 (estimated)
Last update
Sep 27, 2019

Study contacts

Chun Wang, doc.
Contact
fm51109@163.com
15850566376
Chun Wang, doc.
study chair · Nanjing Brain Hospital Nanjing, Jiangsu China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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