Fear of FlyingNCT06758635
Online Versions of Single Session Virtual Reality (VR) Therapy and EMDR Flash Therapy on the Treatment of Flying Fear
A study testing VRET-O Group, Flash-O Group and PYSCHOEDU-O Group in people with Fear of Flying, run by Ibn Haldun University at 1 site in Turkey (Türkiye).
Trial summary
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. 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
- What is being tested?
- VRET-O Group, Flash-O Group and PYSCHOEDU-O Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 1 Sep 2024
- 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
- Between the ages of 18-65
- clinical diagnosis of fear of flying
Who cannot join
- risk of suicide or self-harm,
- psychosis,
- pregnancy
- PTSD,
- recent changes for psychotropic medicine use,
- current receipt of therapy about flying phobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Fear of Flying
- Being tested
- VRET-O Group, Flash-O Group, PYSCHOEDU-O Group
- Keywords
- fear of flying, aviophobia, virtual reality therapy, emdr therapy
- Medical subject headings
- Aerophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRET-O GroupBehavioural
Also called single session online VRET
Arm Description: the participants of this group will get 3 hours lasting online single session VR therapy
Flash-O GroupBehavioural
Arm Description: the participants of this group will get 3 hours lasting online single session EMDR Flash therapy
PYSCHOEDU-O GroupBehavioural
Also called only psychoeducation
Arm Description: the participants of this group will get 1 hour lasting online psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| VRET-O Group | Experimental | the participants of this group will get 3 hours lasting online single session VR therapy Receives: Behavioral: Flash-O Group; Behavioral: PYSCHOEDU-O Group |
| Flash-O Group | Experimental | the participants of this group will get 3 hours lasting online single session EMDR Flash therapy Receives: Behavioral: VRET-O Group; Behavioral: PYSCHOEDU-O Group |
| PYSCHOEDU-O Group | Placebo comparator | the participants of this group will get 1 hour lasting online psychotherapy Receives: Behavioral: VRET-O Group; Behavioral: Flash-O Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAS Test
The Flight Anxiety Situation Questionnaire (FAS)
Measured: From enrollment to the end of the follow up at 4 weeks
VAFAS
A Visual Analogue Flight Anxiety Scale
Measured: From enrollment to the end of the follow up at 4 weeks
FAM Test
The Flight Anxiety Modality Questionnaire (FAM)
Measured: From enrollment to the end of the follow up at 4 weeks
Actual flight
Have an actual flight within 4 weeks after the treatment.
Measured: From enrollment to the end of the follow up at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start15 Dec 2023
- Primary completion15 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Model description
- Accordingly, 89 people who applied voluntarily were divided into three groups randomly: a) psychoeducation and VR exposure b) psychoeducation-only. All participants were given a set of scales consisting: Clinical Global Impression Scale; FAM (Flight Anxiety Modality Questionnaire), FAS (Flight Anxiety Situations Questionnaire), and a Visual Analogue Flight Anxiety Scale (VAFAS), to assess the level of fear of flying before and one month after the treatment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Haldun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Özdil Arıkan, Ibn Haldun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758635
- Sponsor's protocol ID
- E-71395021-020-11584
- Status last verified
- Dec 2024
- First submitted
- 3 Oct 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35401305Van 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.
PubMed 17291954Rothbaum 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.
PubMed 16942963Muhlberger 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.
PubMed 11520010Manfield 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.
PubMed 38260782Maltby 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.
PubMed 12362961Campos 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.
PubMed 30841930
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Versions of Single Sessions Virtual Reality (VR) Therapy and EMDR Flash Therapy on the Treatment of Flying Fear
- ClinicalTrials.gov ID
- NCT06758635
- Acronym / sponsor ID
- E-71395021-020-11584
- Conditions
- Fear of Flying
- Keywords
- fear of flying, aviophobia, virtual reality therapy, emdr therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ibn Haldun UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 Jan 2025 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Accordingly, 89 people who applied voluntarily were divided into three groups randomly: a) psychoeducation and VR exposure b) psychoeducation-only. All participants were given a set of scales consisting: Clinical Global Impression Scale; FAM (Flight Anxiety Modality Questionnaire), FAS (Flight Anxiety Situations Questionnaire), and a Visual Analogue Flight Anxiety Scale (VAFAS), to assess the level of fear of flying before and one month after the treatment.
| Arm | Type | Receives |
|---|---|---|
| VRET-O Group | Experimental | Behavioral: Flash-O Group, Behavioral: PYSCHOEDU-O Groupthe participants of this group will get 3 hours lasting online single session VR therapy |
| Flash-O Group | Experimental | Behavioral: VRET-O Group, Behavioral: PYSCHOEDU-O Groupthe participants of this group will get 3 hours lasting online single session EMDR Flash therapy |
| PYSCHOEDU-O Group | Placebo comparator | Behavioral: VRET-O Group, Behavioral: Flash-O Groupthe participants of this group will get 1 hour lasting online psychotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 18-65
- clinical diagnosis of fear of flying
Key exclusion criteria (6 listed)
- risk of suicide or self-harm,
- psychosis,
- pregnancy
- PTSD,
- recent changes for psychotropic medicine use,
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 |
|---|---|---|
| VRET-O GroupAlso: single session online VRETArm Description: the participants of this group will get 3 hours lasting online single session VR therapy | Behavioural | Flash-O Group, PYSCHOEDU-O Group |
| Flash-O GroupArm Description: the participants of this group will get 3 hours lasting online single session EMDR Flash therapy | Behavioural | PYSCHOEDU-O Group, VRET-O Group |
| PYSCHOEDU-O GroupAlso: only psychoeducationArm Description: the participants of this group will get 1 hour lasting online psychotherapy | Behavioural | Flash-O Group, VRET-O Group |
Primary outcome
FAS Test
Time frame: From enrollment to the end of the follow up at 4 weeks
The Flight Anxiety Situation Questionnaire (FAS)
VAFAS
Time frame: From enrollment to the end of the follow up at 4 weeks
A Visual Analogue Flight Anxiety Scale
FAM Test
Time frame: From enrollment to the end of the follow up at 4 weeks
The Flight Anxiety Modality Questionnaire (FAM)
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.
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 6 Jan 2025.
- Background: PubMed 35401305Yasar 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.
- Background: PubMed 17291954Van 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.
- Background: PubMed 16942963Rothbaum 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.
- Background: PubMed 11520010Muhlberger 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.
- Background: PubMed 38260782Manfield 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.
- Background: PubMed 12362961Maltby 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.
- Background: PubMed 30841930Campos 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.
- Individual participant dataSharing planned: No
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 VRET-O Group, Flash-O Group and PYSCHOEDU-O Group in people with Fear of Flying, run by Ibn Haldun University at 1 site in Turkey (Türkiye).
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 2 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 6 Jan 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
FAS Test (time frame: From enrollment to the end of the follow up at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06758635, which also lists 7 linked publications.
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 6 Jan 2025.