A Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of Flying

Virtual Reality Exposure Therapy Clinical Trial

Official title:

A Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of Flying

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085768
• Other study ID #: SMHC-VR-002
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: November 2023

Study information

• Verified date: October 2023
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore the efficacy of VR exposure intervention in alleviating fear of flying through a randomized controlled study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The flight anxiety situations questionnaire (FAS) score is no less than 56 points (the critical value is set as two or more standard deviations higher than the average of the normal population);
• Aged between 18 and 65 years old;
• Have normal intelligence and good or corrected vision;
• No family history of any mental illness or other mental disorders other than anxiety disorder;
• Currently not receiving any treatment for phobia, including but not limited to taking psychotropic drugs (unless the dose is stable for more than 3 months, and the subject agrees to continue taking the dose throughout the study);
• Have at least 1 flight experience;

Exclusion Criteria:

• The participant cannot tolerate or adapt to VR stimulation;
• The participant was unable to immerse themselves well in the VR environment;
• Severe physical diseases and physical diseases induced by stimulation, including cardiovascular and respiratory diseases, etc.;
• Have a history of neurological diseases (such as epilepsy, cerebrovascular accident, etc.) or brain trauma or brain surgery;
• The subject suffers from a physical disease and is not in a stable treatment period (such as hyperthyroidism, visual impairment, etc.), resulting in the inability to fully participate in the experimental process;
• Pregnant women.

Related Conditions & MeSH terms

• Fear of Flying
• Virtual Reality Exposure Therapy

Intervention

Behavioral:
• VRE intervention
Virtual reality exposure therapy is a new treatment technology developed in recent years. This technology combines virtual reality technology with traditional exposure therapy, and uses virtual reality technology to present the exposure scenes required for exposure therapy. Therefore, it can break through the limitations of time and space and more intuitively display some things that are difficult to simulate in the treatment room. Scenes do not require the client to undergo treatment through imaginary exposure, thereby increasing the immersion and reality of the treatment. Over the past two decades, numerous studies have explored and proven the effectiveness of virtual exposure therapy.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flight Anxiety Situations Questionnaire(FAS)	It was compiled by Van Gerwen et al. in 1999 to assess flight-related anxiety in different situations. It consists of 32 items rated on a 5-point scale from 1 ("Not at all anxious") to 5 ("Extremely anxious"). "), with a total score of 32-160 points. The scale consists of three subscales that assess anticipatory flight anxiety (anxiety that occurs when a person anticipates flying), in-flight anxiety, and generalized flight anxiety, with item numbers of 14, 11, and 7 respectively. This questionnaire has good reliability and validity, has established norms, can be used as a clinical measurement tool for fear of flying, is widely used in clinical practice and research, and is used as the main efficacy indicator.	from baseline to 4 weeks
Secondary	Flight Anxiety Modality Questionnaire(FAM)	It was compiled by Van Gerwen et al. in 1999 and is used to measure the symptom pattern of expressing anxiety in flight situations, including a somatic pattern related to physical symptoms and a cognitive pattern related to the cognition of presence of pain, with a total of 18 items. , rated on a 5-point scale from 1 ("not at all") to 5 ("very strongly"), with a total score of 18-90. The questionnaire has good reliability and validity.	from baseline to 4 weeks
Secondary	The Beck Anxiety Inventory(BAI)	It was compiled by Aaron T. Beck et al. in 1988, there are 21 items in total. The person who fills out the form needs to select the impact of each symptom on him, using a 4-point rating, from 0 ("no impact") to 3 ("severe impact") "), the total score is the sum of all question scores, ranging from 0 to 63 points. The higher the total score, the more serious the subject's anxiety. The Chinese version of BAI has good reliability and validity and is widely used in clinical patients and the general population.	from baseline to 4 weeks
Secondary	State-Trait Anxiety Inventory(STAI)	It was developed by American psychologist Spielberg and others in the late 1960s. It consists of two subscales, including state anxiety subscale and trait anxiety subscale. Each subscale contains 20 items, rated on a 4-point scale from 1 ("not at all") to 4 ("very much"), with higher scores indicating higher levels of anxiety. The Chinese version of STAI has good reliability and validity, and the state anxiety consistency coefficient is 0.90.	STAI-t is assessed only once at baseline. STAI-s is assessed from baseline to 4 weeks.
Secondary	Subjective Units of Distress(SUDs)	It was developed by Wolpe in 1969 that measures the subjective intensity of the pain or distress an individual is currently experiencing through the individual's self-assessment of the position of the current anxiety, fear, or pain situation on the scale. It is primarily used in exposure therapy and is one of the most common scales used to assess treatment progress and how anxiety levels are reduced.	assessed every one minute during intervention, up to 24 hours
Secondary	Igroup Presence Questionnaire(IPQ)	It was compiled by Schubert et al. in 2001, with a total of 14 items and a 5-level score, including three dimensions: spatial immersion, involvement and realism. Wang Xi and others revised the Chinese version on this basis. After exploratory factor analysis, they found that the load of question 11 "How real is the virtual environment to you" was low, so it was deleted. The questionnaire has good reliability and validity.	The IPQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2)
Secondary	Stimulator Sickness Questionnaire(SSQ)	It was developed by Kennedy et al. in 1993 and is widely used in the evaluation of virtual reality systems. It is divided into three categories: eye discomfort, disorientation and nausea, including general discomfort, fatigue, headache, visual fatigue, difficulty Sixteen indicators including concentration.	The SSQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2)
Secondary	Physiological indicators	Data recording uses shimmer3 GSR biosensors, including galvanic skin response sensors, light pulse sensors (earlobes), and a notebook equipped with signal acquisition software to record the participant's galvanic skin response and heart rate.	from baseline to 2 weeks