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

NCT06085768 | Completed

• 1 other identifier: SMHC-VR-002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fear of Flying; Virtual Reality Exposure Therapy

Keywords

fear of flying; virtual reality exposure therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Flight Anxiety Modality Questionnaire(FAM)

  from baseline to 4 weeks

• The Beck Anxiety Inventory(BAI)

  from baseline to 4 weeks

• State-Trait Anxiety Inventory(STAI)

  STAI-t is assessed only once at baseline. STAI-s is assessed from baseline to 4 weeks.

• Subjective Units of Distress(SUDs)

  assessed every one minute during intervention, up to 24 hours

• Igroup Presence Questionnaire(IPQ)

  The IPQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2)

Study Arms (2)

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.

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.

Interventions

VRE intervention BEHAVIORAL

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.

VRE intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Aerophobia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 17, 2023
• Study Start: May 19, 2023
• Primary Completion: June 9, 2023
• Study Completion: November 5, 2023
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

CN (1)