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Flying PhobiaNCT03900559

An Internet-based Treatment for Flying Phobia

A study testing NO-FEAR Airlines in people with Flying Phobia, run by Universitat Jaume I at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Flying phobia (FP) is one of the most prevalent phobias in our society. However, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention, drop out when they are informed about the intervention procedure, or have problems accessing these therapies. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Flying Phobia
What is being tested?
NO-FEAR Airlines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteSpain
Study dates
1 Feb 2018to 1 May 2021
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be between 18-65 years of age
  • To meet current DSM-5 criteria for specific phobia (flying phobia).
  • Be willing to participate in the study.
  • Be able to use a computer and having an Internet connection.
  • Be able to understand and read Spanish.
  • Have an e-mail address.

Who cannot join

  • Be receiving psychological treatment for fear of flying.
  • A severe mental disorder on Axis I: abuse or dependence of alcohol or other substances, psychotic disorder, dementia, bipolar disorder.
  • Severe Personality Disorder.
  • Presence of depressive symptomatology, suicidal ideation or plan.
  • Presence of heart disease.
  • Pregnant women (from the fourth month).

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universitat Jaume I

    Castellon, Castellón, 12006

Other trials in Spain

About this study

Official title: An Internet-based Treatment for Flying Phobia Using 360º Images: A Feasibility Pilot Study

Flying phobia (FP) is one of the most prevalent phobias in our society. However, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention, drop out when they are informed about the intervention procedure, or have problems accessing these therapies.

The aim of the present study is to conduct a feasibility pilot with NO-FEAR Airlines ICBT (Campos et al., 2016) using two types of images in the exposure scenarios (still images vs 360º navigable images). A secondary aim is to explore the potential effectiveness of the two active treatment arms compared to a waiting list control group. Finally, we will explore the role of navigable images compared to the still images in the level of anxiety, sense of presence, and reality judgment in the exposure scenarios and whether the aforementioned variables mediate in treatment efficacy.

Regarding the main aim of this study, we hypothesize that both treatment conditions will be well accepted by the participants, but participants will prefer 360º images over still images.

Read the detailed description

Flying phobia (FP) is one of the most prevalent phobias in our society. Around 25% of the population that flies experiences intense distress during the flight; around 10% of the general population does not fly due to intense fear and 20% of people depend on alcohol or tranquilizers to overcome the fear of flying.

In vivo exposure is the most effective psychological treatment for specific phobias. However, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention, drop out when they are informed about the intervention procedure, or they have problems to access these therapies.

Information and Communication Technologies (ICTs) can improve treatment adherence and acceptance. Particularly, computerized programs offer remarkable advantages such as a reduction in direct therapeutic contact time, the possibility of standardizing treatment as much as possible with a steep exposure gradient, the low cost and, maybe most importantly, access to patients who would not be very willing to subject themselves to in vivo exposure. The application of cognitive-behavioural procedures such as exposure through interactive computer programs is especially recommended.

On the other hand, it is important to explore the role of the degree of immersion and sense of presence in the psychological treatments with iCBTs due to the contradictory conclusions that had been found in the literature. Therefore, it is expected that the present work advances in the knowledge in this field exploring these factors in an Internet-based self-applied treatment program for FP evaluating if a change in the exposure images used in the program NO-FEAR Airlines (Campos et al., 2016) will be feasible in a future RCT.

Conditions
Flying Phobia
Being tested
NO-FEAR Airlines
Keywords
Specific Phobia, Computer-Assisted Exposure, Self-help, Internet-based Therapy, Sense of presence
Medical subject headings
Aerophobia, Phobia, Specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NO-FEAR AirlinesBehavioural

    "NO-FEAR Airlines" is an Internet-based self-applied treatment program that allows people with Flying Phobia the exposure to images and sounds related to their phobic fears on a standard personal computer. The treatment can be totally self-applied.

    "NO-FEAR Airlines" contains 6 scenarios related to the flight process: (1) flight preparation, (2) airport, (3) boarding and taking off, (4) the central part of the flight, (5) the airplane's descent, approach to the runway, and landing, (6) sequences with images and auditory stimuli related to plane crashes.

Study groups in NCT03900559
Study groupRoleWhat they receive
"NO-FEAR Airlines" program with still imagesExperimentalIntervention group that uses "NO-FEAR Airlines" program with still images to carry out the exposure.
Receives: Behavioral: NO-FEAR Airlines
"NO-FEAR Airlines" program with still and navigable imagesExperimentalIntervention group that uses "NO-FEAR Airlines" program with still and navigable images to carry out the exposure.
Receives: Behavioral: NO-FEAR Airlines
Waiting list control groupNo interventionParticipants of this group are able to access "NO-FEAR Airlines" program after 6 weeks of waiting period. After that period, those participants still interested in receiving assistance are randomly assigned to one of two intervention conditions (only still images or still + navigable images).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Expectations Scale and Satisfaction Scale (adapted from Borkovec & Nau, 1972)

    This self-report inventory measures the patients' expectations before they start the treatment and after they receive a brief explanation about the intervention and their experimental condition. The same questions have to be answered when the patient completes the treatment in order to assess satisfaction. The 6 items are rated from 1 ("Not at all") to 10 ("Highly").

    Measured: Up to 12 months

  2. Preferences questionnaire

    This questionnaire collects the patient's preferences regarding the two types of images included in this study (navigable and still images) through 5 dichotomous questions where they have to choose one of the two conditions. Participants will answer these questions before the treatment and before knowing the condition to which they are allocated (after the characteristics of each type of image are explained) and after they have completed the treatment (and after seeing a short video showing the image condition they did not receive).

    Measured: Up to 12 months

  3. Qualitative Interview

    This interview assesses the participant's opinion of the intervention program after finishing it. The interview contains 13 items that the patient has to rate on a scale ranging from 1 ("very little") to 5 ("very much") and explain the reasons for their rating on each question. There are also two open questions where the participants have to give their overall opinion about the intervention program and the program images. In this interview, the perceived sense of presence and reality judgement in each scenario will also be assessed.

    Measured: Up to 12 months

Secondary outcomes (5)
  1. Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)

    Participants assessed their fear, avoidance and belief in catastrophic thought on a scale ranging from 0 ("No fear at all," "I never avoid") to 10 ("Severe fear," "I always avoid") for situations related with flying.

    Measured: Up to 12 months

  2. The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994).

    The clinician rates the severity of the patient's phobia on a scale from 0 to 8, where 0 = symptom free and 8 = extremely severe.

    Measured: Up to 12 months

  3. Patient's Improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).

    One item on the CGI scale was adapted in order to assess the level of improvement achieved by the patient (compared to the baseline) on a 7-point scale (1 "much worse" to 7 "much better"). This scale is answered by the patient.

    Measured: Up to 12 months

  4. Fear of Flying Questionnaire (FFQ-II; Bornas et al, 1999)

    The FFQ is a 30-item self-report questionnaire that assesses the anxiety the person feels in different situations of the flight process: anxiety during the flight, anxiety experienced getting on the plane, and anxiety experienced due to the observation of neutral or unpleasant flying-related situations. For each item, respondents rate their degree of discomfort associated with the situation on a scale from 1 to 9 (1 = not at all, 9 = very much). Scores range from 30 to 270. Internal consistency was α = .97, and test-retest reliability (15-day retest period) was r = .92 (Bornas et al. 1999).

    Measured: Up to 12 months

  5. Fear of Flying Scale (FFS; Haug et al., 1987).

    The FFS is a 21-item self-report measure to assess fear in different flying situations. Fear elicited by each situation was rated on a 4-point scale (1= not at all, 4 = very much), with scores ranging from 21 to 84. The original FFS reported a Cronbach's alpha of .94 and retest reliability (after a three-month period) of .86 (Haug et al., 1987).

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2019
  2. Study start1 Feb 2018
  3. Primary completion15 Oct 2020
  4. Study completion1 May 2021

Resources

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
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03900559
Sponsor's protocol ID
UJaumeI5
Status last verified
Jun 2021
First submitted
8 Jan 2019
Last updated
28 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Botella, C., Osma, J., García-Palacios, A., Quero, S., & Baños, R.M. (2004). Treatment of flying phobia using virtual reality: data from a 1-year follow-up using a multiple baseline design. Clinical Psychology and psychotherapy, 11, 311-323.

  • Campos D, Breton-Lopez J, Botella C, Mira A, Castilla D, Banos R, Tortella-Feliu M, Quero S. An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial. BMC Psychiatry. 2016 Aug 20;16:296. doi: 10.1186/s12888-016-0996-1.

    PubMed 27544428
  • Campos D, Mira A, Breton-Lopez J, Castilla D, Botella C, Banos RM, Quero S. The acceptability of an Internet-based exposure treatment for flying phobia with and without therapist guidance: patients' expectations, satisfaction, treatment preferences, and usability. Neuropsychiatr Dis Treat. 2018 Mar 28;14:879-892. doi: 10.2147/NDT.S153041. eCollection 2018.

    PubMed 29636613
  • Garcia-Palacios A, Botella C, Hoffman H, Fabregat S. Comparing acceptance and refusal rates of virtual reality exposure vs. in vivo exposure by patients with specific phobias. Cyberpsychol Behav. 2007 Oct;10(5):722-4. doi: 10.1089/cpb.2007.9962.

    PubMed 17927544
  • Kazdin, A. E. (2015). Evidence-based psychotherapies II: changes in models of treatment and treatment delivery. South African Journal of Psychology, 45(1), 3-21.

  • Tortella-Feliu M, Botella C, Llabres J, Breton-Lopez JM, del Amo AR, Banos RM, Gelabert JM. Virtual reality versus computer-aided exposure treatments for fear of flying. Behav Modif. 2011 Jan;35(1):3-30. doi: 10.1177/0145445510390801.

    PubMed 21177516
  • Mor S, Botella C, Campos D, Carlbring P, Tur C, Quero S. An internet-based treatment for flying phobia using 360 degrees images: A feasibility pilot study. Internet Interv. 2022 Feb 16;28:100510. doi: 10.1016/j.invent.2022.100510. eCollection 2022 Apr.

    PubMed 35242593
  • Mor S, Botella C, Campos D, Tur C, Castilla D, Soler C, Quero S. An Internet-based treatment for Flying Phobia using 360 degrees images: Study protocol for a feasibility pilot study. Internet Interv. 2021 Apr 6;24:100387. doi: 10.1016/j.invent.2021.100387. eCollection 2021 Apr.

    PubMed 33936953

Questions about this trial

What is this clinical trial studying?

A study testing NO-FEAR Airlines in people with Flying Phobia, run by Universitat Jaume I at 1 site in Spain.

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 6 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 28 Jun 2021. 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 Spain. 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. 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?

Expectations Scale and Satisfaction Scale (adapted from Borkovec & Nau, 1972) (time frame: Up to 12 months). The study lists 3 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 NCT03900559, which also lists 8 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 28 Jun 2021.

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