Fear of FlyingNCT06085768
A Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of Flying
A study testing VRE intervention in people with Fear of Flying and Virtual Reality Exposure Therapy, run by Shanghai Mental Health Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Flying, Virtual Reality Exposure Therapy
- What is being tested?
- VRE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2023to 5 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
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.
- Conditions
- Fear of Flying, Virtual Reality Exposure Therapy
- Being tested
- VRE intervention
- Keywords
- fear of flying, virtual reality exposure therapy
- Medical subject headings
- Aerophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRE interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VRE intervention group | Experimental | The intervention group will receive 2 VR exposure interventions, once a week, and each intervention will experience 2 complete flight processes for about 90 minutes each time. A complete flight process includes: (1) waiting for the airport bus at the station, (2) check-in, security check, waiting, and boarding at the airport, (3) taxiing, taking off, cruising, landing, and leaving the aircraft during flight. Among them, the flight process requires the participant to sit on the flight seat, which takes about 24 minutes each time.
A scale assessment and skin electrode and heart rate data collection will be conducted before and after each intervention. The participants' skin electrode and heart rate data will also be collected during the intervention. They will be followed up in the 2nd week after the intervention. Follow-up content includes scale evaluation and safety evaluation. Receives: Behavioral: VRE intervention |
| wait-list control group | No intervention | The control group will receive scale assessments in weeks 1, 2, and 4, and after the waiting period, receive the same VR exposure intervention once a week for 2 weeks as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 4 weeks
Secondary outcomes (7)
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.
Measured: from baseline to 4 weeks
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.
Measured: from baseline to 4 weeks
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.
Measured: STAI-t is assessed only once at baseline. STAI-s is assessed from baseline to 4 weeks.
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.
Measured: assessed every one minute during intervention, up to 24 hours
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.
Measured: The IPQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2)
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.
Measured: The SSQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2)
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.
Measured: from baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start19 May 2023
- Primary completion9 Jun 2023
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of FlyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085768
- Sponsor's protocol ID
- SMHC-VR-002
- Status last verified
- May 2025
- First submitted
- 3 Oct 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of Flying
- ClinicalTrials.gov ID
- NCT06085768
- Acronym / sponsor ID
- SMHC-VR-002
- Conditions
- Fear of Flying, Virtual Reality Exposure Therapy
- Keywords
- fear of flying, virtual reality exposure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRE intervention group | Experimental | Behavioral: VRE interventionThe intervention group will receive 2 VR exposure interventions, once a week, and each intervention will experience 2 complete flight processes for about 90 minutes each time. A complete flight process includes: (1) waiting for the airport bus at the station, (2) check-in, security check, waiting, and boarding at the airport, (3) taxiing, taking off, cruising, landing, and leaving the aircraft during flight. Among them, the flight process requires the participant to sit on the flight seat, which takes about 24 minutes each time. A scale assessment and skin electrode and heart rate data collection will be conducted before and after each intervention. The participants' skin electrode and heart rate data will also be collected during the intervention. They will be followed up in the 2nd week after the intervention. Follow-up content includes scale evaluation and safety evaluation. |
| wait-list control group | No intervention | –The control group will receive scale assessments in weeks 1, 2, and 4, and after the waiting period, receive the same VR exposure intervention once a week for 2 weeks as the intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRE interventionVirtual 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. | Behavioural | VRE intervention group |
Primary outcome
Flight Anxiety Situations Questionnaire(FAS)
Time frame: from baseline to 4 weeks
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.
7 secondary outcomes
Flight Anxiety Modality Questionnaire(FAM)
Time frame: from baseline to 4 weeks
The Beck Anxiety Inventory(BAI)
Time frame: from baseline to 4 weeks
State-Trait Anxiety Inventory(STAI)
Time frame: STAI-t is assessed only once at baseline. STAI-s is assessed from baseline to 4 weeks.
Subjective Units of Distress(SUDs)
Time frame: assessed every one minute during intervention, up to 24 hours
Igroup Presence Questionnaire(IPQ)
Time frame: The IPQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2)
Stimulator Sickness Questionnaire(SSQ)
Time frame: The SSQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2)
Physiological indicators
Time frame: from baseline to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRE intervention in people with Fear of Flying and Virtual Reality Exposure Therapy, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flight Anxiety Situations Questionnaire(FAS) (time frame: from baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.