NCT06758635

Brief 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. Follow up will be performed one month after the intervention. Accordingly, 89 people who applied voluntarily were divided into three groups randomly:

  1. 1.psychoeducation and Virtual reality therapy
  2. 2.Flash technique
  3. 3.psychoeducation-only.
  4. 4.The Clinical Global Impressions Scale
  5. 5.FAM (Flight Anxiety Modality Questionnaire),
  6. 6.FAS (Flight Anxiety Situations Questionnaire), and
  7. 7.Visual Analogue Flight Anxiety Scale (VAFAS), to assess the level of fear of flying before and one month after the treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
Last Updated

January 6, 2025

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

October 3, 2024

Last Update Submit

December 27, 2024

Conditions

Keywords

fear of flyingaviophobiavirtual reality therapyemdr therapy

Outcome Measures

Primary Outcomes (4)

  • FAS Test

    The Flight Anxiety Situation Questionnaire (FAS)

    From enrollment to the end of the follow up at 4 weeks

  • VAFAS

    A Visual Analogue Flight Anxiety Scale

    From enrollment to the end of the follow up at 4 weeks

  • FAM Test

    The Flight Anxiety Modality Questionnaire (FAM)

    From enrollment to the end of the follow up at 4 weeks

  • Actual flight

    Have an actual flight within 4 weeks after the treatment.

    From enrollment to the end of the follow up at 4 weeks

Study Arms (3)

VRET-O Group

EXPERIMENTAL

the participants of this group will get 3 hours lasting online single session VR therapy

Behavioral: Flash-O GroupBehavioral: PYSCHOEDU-O Group

Flash-O Group

EXPERIMENTAL

the participants of this group will get 3 hours lasting online single session EMDR Flash therapy

Behavioral: VRET-O GroupBehavioral: PYSCHOEDU-O Group

PYSCHOEDU-O Group

PLACEBO COMPARATOR

the participants of this group will get 1 hour lasting online psychotherapy

Behavioral: VRET-O GroupBehavioral: Flash-O Group

Interventions

VRET-O GroupBEHAVIORAL

Arm Description: the participants of this group will get 3 hours lasting online single session VR therapy

Also known as: single session online VRET
Flash-O GroupPYSCHOEDU-O Group
Flash-O GroupBEHAVIORAL

Arm Description: the participants of this group will get 3 hours lasting online single session EMDR Flash therapy

PYSCHOEDU-O GroupVRET-O Group

Arm Description: the participants of this group will get 1 hour lasting online psychotherapy

Also known as: only psychoeducation
Flash-O GroupVRET-O Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18-65
  • clinical diagnosis of fear of flying

You may not qualify if:

  • risk of suicide or self-harm,
  • psychosis,
  • pregnancy
  • PTSD,
  • recent changes for psychotropic medicine use,
  • current receipt of therapy about flying phobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zehra Ozdil Arikan

Istanbul, Turkey, 34660, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 35401305BACKGROUND
  • 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.

    PMID: 17291954BACKGROUND
  • 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.

    PMID: 16942963BACKGROUND
  • 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.

    PMID: 11520010BACKGROUND
  • 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.

    PMID: 38260782BACKGROUND
  • 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.

    PMID: 12362961BACKGROUND
  • 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.

    PMID: 30841930BACKGROUND

MeSH Terms

Conditions

Aerophobia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Psychologist

Study Record Dates

First Submitted

October 3, 2024

First Posted

January 6, 2025

Study Start

December 15, 2023

Primary Completion

August 15, 2024

Study Completion

September 1, 2024

Last Updated

January 6, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations