- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06758635
Online Versions of Single Session Virtual Reality (VR) Therapy and EMDR Flash Therapy on the Treatment of Flying Fear
Online Versions of Single Sessions Virtual Reality (VR) Therapy and EMDR Flash Therapy on the Treatment of Flying Fear
The purpose of this experimental study is to explore effectiveness of Cognitive Behavioural Therapy based Virtual Reality Therapy and Eye Movement Desensitization and Reprocessing Therapy based Flash Technique compared to psychoeducation only group through developing one session online protocols. Follow up will be performed one month after the intervention.
Accordingly, 89 people who applied voluntarily were divided into three groups randomly:
- psychoeducation and Virtual reality therapy
- Flash technique
- psychoeducation-only.
All participants were given a set of scales consisting:
- The Clinical Global Impressions Scale
- FAM (Flight Anxiety Modality Questionnaire),
- FAS (Flight Anxiety Situations Questionnaire), and
- Visual Analogue Flight Anxiety Scale (VAFAS), to assess the level of fear of flying before and one month after the treatment.
This work was supported by the Research Fund of Ibn Haldun University. Project Name: Online Single Session Virtual Reality Therapy Programme for Fear of Flying. Project Number: 2238.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are several therapy methods that can help individuals to overcome their flying phobia. Although traditional fear of flying exposure approaches is extensively employed, they have substantial limitations. Classical in vivo exposure for flying is not common because it is very expensive and very hard to adapt for every flight condition. Whereas VRET can give uniquely tailored exposure scenarios like air turbulence or weather conditions, in vivo exposure is harder to deliver since the therapist has little control over the scenario (Rothbaum et al., 2006). In the therapy of specific phobias, virtual reality therapy has been the most widely employed and has garnered the most empirical attention (Price et al., 2008).
While cognitive behavioral therapy (CBT) is the mainstream in the flight phobia treatment, empirical research on different psychotherapy strategies is similarly useful in the treatment of flight phobia (Triscari et al., 2015). Specific phobia studies on the Eye Movement Desensitization and Reprocessing (EMDR) therapy indicated that EMDR therapy can provide important developments within a restricted variety of sessions (De Jongh et al., 1999). The Flash technique is a new individual or group intervention technique of EMDR that aims to reduce distress and suffering related to traumatic memories quickly (Wong, 2019).
The purpose of this experimental study is to explore the effectiveness of Cognitive Behavioural Therapy based Virtual Reality Therapy and Eye Movement Desensitization and Reprocessing Therapy based Flash Technique compared to Psychoeducation only groups through developing one-session protocols.
Hypothesis
- Is VRET-O more effective than the psychoeducation-only group for reducing participants' anxiety and avoidance behavior for fear of flying?
- Is FLASH-O more effective than the psychoeducation-only group for reducing participants' anxiety and avoidance behaviour for fear of flying?
- Is there any significantly meaningful decrease in post-test scores of participants' anxiety and avoidance behaviour for fear of flying when compared to the pretest scores?
Participants were blinded to which group they would be in when they started the study via the Google form link. Randomization was performed by two independent investigators according to the order of application. Randomization was performed according to the order of the list in which the participants signed the consent form. Participants were randomly assigned to one of the three groups according to the computer-generated number sequence in a 1:1:1 ratio from https://www.randomizer.org/. both study investigators and participants were blinded to the group to which they were assigned. After randomization, each participant was informed in detail about the treatment and waiting process.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34660
- Zehra Ozdil Arikan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 18-65
- clinical diagnosis of fear of flying
Exclusion Criteria:
risk of suicide or self-harm,
- psychosis,
- pregnancy
- PTSD,
- recent changes for psychotropic medicine use,
- current receipt of therapy about flying phobia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VRET-O Group
the participants of this group will get 3 hours lasting online single session VR therapy
|
Arm Description: the participants of this group will get 3 hours lasting online single session EMDR Flash therapy
Arm Description: the participants of this group will get 1 hour lasting online psychotherapy
Other Names:
|
|
Experimental: Flash-O Group
the participants of this group will get 3 hours lasting online single session EMDR Flash therapy
|
Arm Description: the participants of this group will get 1 hour lasting online psychotherapy
Other Names:
Arm Description: the participants of this group will get 3 hours lasting online single session VR therapy
Other Names:
|
|
Placebo Comparator: PYSCHOEDU-O Group
the participants of this group will get 1 hour lasting online psychotherapy
|
Arm Description: the participants of this group will get 3 hours lasting online single session EMDR Flash therapy
Arm Description: the participants of this group will get 3 hours lasting online single session VR therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FAS Test
Time Frame: From enrollment to the end of the follow up at 4 weeks
|
The Flight Anxiety Situation Questionnaire (FAS)
|
From enrollment to the end of the follow up at 4 weeks
|
|
VAFAS
Time Frame: From enrollment to the end of the follow up at 4 weeks
|
A Visual Analogue Flight Anxiety Scale
|
From enrollment to the end of the follow up at 4 weeks
|
|
FAM Test
Time Frame: From enrollment to the end of the follow up at 4 weeks
|
The Flight Anxiety Modality Questionnaire (FAM)
|
From enrollment to the end of the follow up at 4 weeks
|
|
Actual flight
Time Frame: From enrollment to the end of the follow up at 4 weeks
|
Have an actual flight within 4 weeks after the treatment.
|
From enrollment to the end of the follow up at 4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rothbaum BO, Anderson P, Zimand E, Hodges L, Lang D, Wilson J. Virtual reality exposure therapy and standard (in vivo) exposure therapy in the treatment of fear of flying. Behav Ther. 2006 Mar;37(1):80-90. doi: 10.1016/j.beth.2005.04.004. Epub 2006 Feb 24.
- Campos D, Breton-Lopez J, Botella C, Mira A, Castilla D, Mor S, Banos R, Quero S. Efficacy of an internet-based exposure treatment for flying phobia (NO-FEAR Airlines) with and without therapist guidance: a randomized controlled trial. BMC Psychiatry. 2019 Mar 6;19(1):86. doi: 10.1186/s12888-019-2060-4.
- Yasar AB, Konuk E, Kavakci O, Uygun E, Gundogmus I, Taygar AS, Uludag E. A Randomized-Controlled Trial of EMDR Flash Technique on Traumatic Symptoms, Depression, Anxiety, Stress, and Life of Quality With Individuals Who Have Experienced a Traffic Accident. Front Psychol. 2022 Mar 24;13:845481. doi: 10.3389/fpsyg.2022.845481. eCollection 2022.
- Van Gerwen LJ, Diekstra RF, Arondeus JM, Wolfger R. Fear of flying treatment programs for passengers: an international update. Travel Med Infect Dis. 2004 Feb;2(1):27-35. doi: 10.1016/j.tmaid.2004.01.002.
- Muhlberger A, Herrmann MJ, Wiedemann GC, Ellgring H, Pauli P. Repeated exposure of flight phobics to flights in virtual reality. Behav Res Ther. 2001 Sep;39(9):1033-50. doi: 10.1016/s0005-7967(00)00076-0.
- Manfield PE, Taylor G, Dornbush E, Engel L, Greenwald R. Preliminary evidence for the acceptability, safety, and efficacy of the flash technique. Front Psychiatry. 2024 Jan 8;14:1273704. doi: 10.3389/fpsyt.2023.1273704. eCollection 2023.
- Maltby N, Kirsch I, Mayers M, Allen GJ. Virtual reality exposure therapy for the treatment of fear of flying: a controlled investigation. J Consult Clin Psychol. 2002 Oct;70(5):1112-8. doi: 10.1037//0022-006x.70.5.1112.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E-71395021-020-11584
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fear of Flying
-
Emory UniversityNational Institute of Mental Health (NIMH)Completed
-
Shanghai Mental Health CenterCompletedA Preliminary Study on the Intervention Effect of Virtual Reality Exposure Therapy on Fear of FlyingFear of Flying | Virtual Reality Exposure TherapyChina
-
Idan Moshe AderkaCompleted
-
University of RegensburgCompleted
-
Cukurova UniversityCompletedPregnancy | Fear | Education | Fear of Childbirth | BirthTurkey
-
University of Social Sciences and Humanities, WarsawCompletedFear of FailurePoland
-
University of Las Palmas de Gran CanariaServicio Canario de SaludCompleted
-
Uppsala UniversityCompleted
-
Marmara UniversityCompleted
-
Nagihan AcetCompletedFear of Falling | Fear of MovementTurkey
Clinical Trials on Flash-O Group
-
Trauma Institute & Child Trauma InstituteUnknown
-
Yuzuncu Yıl UniversityRecruiting
-
Trauma Institute & Child Trauma InstituteUnknownTrauma, Psychological | Motor Vehicle AccidentUnited States
-
The University of Hong KongLondon School of Hygiene and Tropical Medicine; Nagasaki UniversityCompleted
-
Bursa Yüksek İhtisas Education and Research HospitalNot yet recruiting
-
Varian, a Siemens Healthineers CompanyActive, not recruitingBone Metastases in the ThoraxUnited States
-
Varian, a Siemens Healthineers CompanyCompletedBone MetastasisUnited States
-
Seoul National University HospitalUnknownEndotracheal IntubationKorea, Republic of
-
Campus Bio-Medico UniversityActive, not recruiting
-
Ain Shams UniversityCompletedPropofol Adverse Reaction | Injection Site ColdnessEgypt