Clinical trial NCT06085768: A Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of Flying
Official title: A Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of Flying
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Flying
Virtual Reality Exposure Therapy
Keywords: fear of flying
virtual reality exposure therapy
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Flight Anxiety Situations Questionnaire(FAS)
timeFrame: from baseline to 4 weeks
Secondary outcomes:
measure: Flight Anxiety Modality Questionnaire(FAM)
timeFrame: from baseline to 4 weeks
measure: The Beck Anxiety Inventory(BAI)
timeFrame: from baseline to 4 weeks
measure: State-Trait Anxiety Inventory(STAI)
timeFrame: STAI-t is assessed only once at baseline. STAI-s is assessed from baseline to 4 weeks.
measure: Subjective Units of Distress(SUDs)
timeFrame: assessed every one minute during intervention, up to 24 hours
measure: Igroup Presence Questionnaire(IPQ)
timeFrame: The IPQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2)
measure: Stimulator Sickness Questionnaire(SSQ)
timeFrame: The SSQ should be assessed each time after the VRE intervention for participants with fear of flying. (at week 1, 2)
measure: Physiological indicators
timeFrame: from baseline to 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References: