An interventional study of VRE intervention in Fear of Flying and Virtual Reality Exposure Therapy, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment
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.
Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: VRE 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.
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.
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.
Time frame: from baseline to 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
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
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.
Time frame: from baseline to 2 weeks
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Shanghai Mental Health Center