Flying PhobiaNCT02298478
Efficacy of an Internet-based Treatment for Flying Phobia: NO-FEAR Airlines
A study testing NO-FEAR Airlines in people with Flying Phobia, run by Universitat Jaume I at 1 site in Spain.
Trial summary
The purpose of this study is to determine the efficacy of a computer-aided self-help treatment for flying phobia with or without support by the therapist, compared to a waiting list control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flying Phobia
- What is being tested?
- NO-FEAR Airlines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2015to Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be older than 18 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 at home.
- 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: abuse or dependence of alcohol or other substances, psychotic disorder, dementia or bipolar disorder.
- Presence of depressive symptomatology, suicidal ideation or plan.
- Presence of heart disease.
- Pregnant women (from the fourth month).
- Receiving pharmacological treatment is not an exclusion criterion during the study period, but the increase, decrease and/or change in the medication during the study period will imply the participant's exclusion from subsequent analyses.
- Participants with comorbid and related disorders (i.e., panic disorder, agoraphobia, claustrophobia or acrophobia) will be included once flying phobia is the primary diagnosis. In contrast, participants who do not meet inclusion criteria will be encouraged to seek treatment alternatives better suited to their specific needs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Internet-based Treatment for Flying Phobia: A Randomized Controlled Trial
The purpose of this study is to determine the efficacy of a computer-aided self-help treatment for flying phobia with or without support by the therapist, compared to a waiting list control group.
Secondary objectives: a) to explore two ways of delivering NO-FEAR Airlines, with or without therapist guidance and b) to study the patients' acceptability through expectations, preferences and satisfaction towards the online program. In this work, we present the study design.
The principal hypothesis is that the two intervention groups will improve significantly compared to the waiting list control group.
Read the detailed description
One of the most prevalent phobias in our society is the fear of flying or flying phobia (FP). Surveys which identify clinically significant phobias estimate point prevalence at approximately 2.5% of the adult population. Around 10% of the general population do not fly due to intense fear, 25% of the population that fly experience intense distress during the flight and 20% of people depend on alcohol or tranquilizers to overcome the fear of flying.
The most effective psychological technique for the treatment of phobias is in vivo exposure. Besides, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention or drop out (around 25%) when they are informed about the intervention procedure or they have problems to access to these therapies.
Information and Communication Technologies (ICT) are pioneer applications that can improve treatment adherence and acceptance. Specifically, Computerized programs boasts remarkable advantages beyond strictly therapeutic and effectiveness-related ones in treating fear of flying: a reduction in direct therapeutic contact time, the possibility of standardizing treatment to the maximum, the low cost - which allows a greater extension - and, perhaps most importantly, access to patients who would not be very willing to subject themselves to live exposure (a real flight) with a steep exposure gradient. The application of cognitive-behavioural procedures such as exposure through interactive computer programs is especially recommended.
- Conditions
- Flying Phobia
- Being tested
- NO-FEAR Airlines
- Keywords
- Self-help, Computer-aided Treatment, Internet, Flying phobia, minimal contact therapies, Cognitive-Behavioural Treatment, Waiting list control group
- Medical subject headings
- Aerophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO-FEAR AirlinesBehavioural
Also called SIN MIEDO Airlines, Computer-aided Self-help Treatment for Flying Phobia, Internet-based treatment for flying phobia
"NO-FEAR Airlines" is a computer program that allows people who are afraid to fly to be exposed to images and sounds related to their phobic fears on a standard personal computer. The treatment can be totally self-applied.
"NO-FEAR Airlines" divides the flight process into six sequential stages: (1) flight preparation, (2) a series of activities immediately prior to flying on the day of the flight, (3) boarding and taking off, (4) the central part of the flight, (5) the airplane's descent, approach to the runway and landing, (6) sequence with images and auditory stimuli related to plane crashes.
| Study group | Role | What they receive |
|---|---|---|
| Group without support by the therapist | Experimental | Intervention group that do the "NO-FEAR Airlines" program and does not receive support by the therapist. Receives: Behavioral: NO-FEAR Airlines |
| Group with support by the therapist | Experimental | Intervention group that do the "NO-FEAR Airlines" program and receives support by the therapist (a brief weekly five-minutes call). Receives: Behavioral: NO-FEAR Airlines |
| Waiting list control group | Other | Control group that could access the "NO-FEAR Airlines" program after waiting for 6 weeks.
After that time, those participants still interested were randomly assigned to one of two intervention conditions (with or without support by the therapist). Receives: Behavioral: NO-FEAR Airlines |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fear of Flying Questionnaire-II (FFQ-II; Bornas, Tortella-Feliu, García de la Banda, Fullana, & Llabrés, 1999).
The FFQ is a 30-item self-report instrument describing situations related to flying: anxiety during flight, anxiety experienced getting on the plane, and anxiety experienced by the observation of neutral or unpleasant flying related situations. For each item, respondents rated their degree of discomfort associated with the situation on a scale of 1 to 9 (1 = not at all, 9 = very much). Scores ranged from 30 to 270. As reported by Bornas et al. (1999), internal consistency was α = .97 and retest reliability (15-day retest period) was r = .92.
Measured: up to 12 months
The Fear of Flying scale (FFS; Haug et al. (1987)
FFS is a 21-item self-report measure for assessing fear associated with various air travel situations. Fear elicited by each situation was rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84. In the original FFS (Haug et al., 1987) Cronbach's alpha was .94 and retest reliability (at three months) was .86.
Measured: up to 12 months
Secondary outcomes (2)
Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)
Participants assessed their fear and avoidance on a scale ranging from 0 ("No fear at all," "I never avoid") to 10 ("Severe fear," "I always avoid") for situations related to flying.
The degree of belief in catastrophic thought was also assessed on a 0 to 10 scale.
Measured: up to 12 months
The Fear of flying scale (FFS; Haug et al., 1987)
FFS is a 21-item self-report measure for assessing fear associated with various air travel situations. Fear elicited by each situation was rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84. In the original FFS (Haug et al., 1987) Cronbach's alpha was .94 and retest reliability (at three months) was .86.
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.
- First posted24 Nov 2014 (estimated)
- Study start1 Sep 2015
- Primary completionSep 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Flying PhobiaStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soledad Quero, Full professor, Study director, University Jaume I, Castellon, Spain.Juana Bretón, Assistant professor, Study director, University Jaume I, Castellon, Spain.Daniel Campos, PhD student, Study chair, University Jaume I, Castellon, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298478
- Sponsor's protocol ID
- UJaumeI05
- Status last verified
- Mar 2018
- First submitted
- 3 Nov 2014
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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 21177516Bornas, X., Fullana, M.A., Tortella-Feliu, M., Llabrés, J. & García de la Banda, G. Computer-assisted therapy in the treatment of flight phobia: a case report. Cognitive and Behavioral Practice, 8, 234-240, 2001.
Bornas, X., Tortella-Feliu, M. & Llabrés, J. Do all treatments work for flight phobia? Computer-assisted exposure versus a brief multicomponent nonexposure treatment. Psychotherapy Research, 16, 41-50, 2006.
Bornas, X., Tortella-Feliu, M., García de la Banda, G., Fullana, M. A., & Llabrés, J. Validación factorial del Cuestionario de Miedo a Volar [Factorial validation of the Fear of Flying Questionnaire]. Análisis y Modificación de Conducta, 25, 885-907, 1999.
Botella C, Quero S, Banos RM, Garcia-Palacios A, Breton-Lopez J, Alcaniz M, Fabregat S. Telepsychology and self-help: the treatment of phobias using the internet. Cyberpsychol Behav. 2008 Dec;11(6):659-64. doi: 10.1089/cpb.2008.0012.
PubMed 18991528Quero S, Campos D, Riera Del Amo A, Breton-Lopez J, Tortella-Feliu M, Banos RM, Botella C. NO-FEAR Airlines: A Computer-aided Self-help Treatment for Flying Phobia. Stud Health Technol Inform. 2015;219:197-201.
PubMed 26799907Campos 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 30841930Campos 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Internet-based Treatment for Flying Phobia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02298478
- Acronym / sponsor ID
- UJaumeI05
- Conditions
- Flying Phobia
- Keywords
- Self-help, Computer-aided Treatment, Internet, Flying phobia, minimal contact therapies, Cognitive-Behavioural Treatment, Waiting list control group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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 study is to determine the efficacy of a computer-aided self-help treatment for flying phobia with or without support by the therapist, compared to a waiting list control group.
Secondary objectives: a) to explore two ways of delivering NO-FEAR Airlines, with or without therapist guidance and b) to study the patients' acceptability through expectations, preferences and satisfaction towards the online program. In this work, we present the study design.
The principal hypothesis is that the two intervention groups will improve significantly compared to the waiting list control group.
Detailed description
One of the most prevalent phobias in our society is the fear of flying or flying phobia (FP). Surveys which identify clinically significant phobias estimate point prevalence at approximately 2.5% of the adult population. Around 10% of the general population do not fly due to intense fear, 25% of the population that fly experience intense distress during the flight and 20% of people depend on alcohol or tranquilizers to overcome the fear of flying.
The most effective psychological technique for the treatment of phobias is in vivo exposure. Besides, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention or drop out (around 25%) when they are informed about the intervention procedure or they have problems to access to these therapies.
Information and Communication Technologies (ICT) are pioneer applications that can improve treatment adherence and acceptance. Specifically, Computerized programs boasts remarkable advantages beyond strictly therapeutic and effectiveness-related ones in treating fear of flying: a reduction in direct therapeutic contact time, the possibility of standardizing treatment to the maximum, the low cost - which allows a greater extension - and, perhaps most importantly, access to patients who would not be very willing to subject themselves to live exposure (a real flight) with a steep exposure gradient. The application of cognitive-behavioural procedures such as exposure through interactive computer programs is especially recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group without support by the therapist | Experimental | Behavioral: NO-FEAR AirlinesIntervention group that do the "NO-FEAR Airlines" program and does not receive support by the therapist. |
| Group with support by the therapist | Experimental | Behavioral: NO-FEAR AirlinesIntervention group that do the "NO-FEAR Airlines" program and receives support by the therapist (a brief weekly five-minutes call). |
| Waiting list control group | Other | Behavioral: NO-FEAR AirlinesControl group that could access the "NO-FEAR Airlines" program after waiting for 6 weeks. After that time, those participants still interested were randomly assigned to one of two intervention conditions (with or without support by the therapist). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be older than 18 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 at home.
- Be able to understand and read Spanish.
Key exclusion criteria (7 listed)
- Be receiving psychological treatment for fear of flying.
- A severe mental disorder: abuse or dependence of alcohol or other substances, psychotic disorder, dementia or bipolar disorder.
- Presence of depressive symptomatology, suicidal ideation or plan.
- Presence of heart disease.
- Pregnant women (from the fourth month).
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 |
|---|---|---|
| NO-FEAR AirlinesAlso: SIN MIEDO Airlines, Computer-aided Self-help Treatment for Flying Phobia, Internet-based treatment for flying phobia"NO-FEAR Airlines" is a computer program that allows people who are afraid to fly to be exposed to images and sounds related to their phobic fears on a standard personal computer. The treatment can be totally self-applied. "NO-FEAR Airlines" divides the flight process into six sequential stages: (1) flight preparation, (2) a series of activities immediately prior to flying on the day of the flight, (3) boarding and taking off, (4) the central part of the flight, (5) the airplane's descent, approach to the runway and landing, (6) sequence with images and auditory stimuli related to plane crashes. | Behavioural | Group with support by the therapist, Group without support by the therapist, Waiting list control group |
Primary outcome
The Fear of Flying Questionnaire-II (FFQ-II; Bornas, Tortella-Feliu, García de la Banda, Fullana, & Llabrés, 1999).
Time frame: up to 12 months
The FFQ is a 30-item self-report instrument describing situations related to flying: anxiety during flight, anxiety experienced getting on the plane, and anxiety experienced by the observation of neutral or unpleasant flying related situations. For each item, respondents rated their degree of discomfort associated with the situation on a scale of 1 to 9 (1 = not at all, 9 = very much). Scores ranged from 30 to 270. As reported by Bornas et al. (1999), internal consistency was α = .97 and retest reliability (15-day retest period) was r = .92.
The Fear of Flying scale (FFS; Haug et al. (1987)
Time frame: up to 12 months
FFS is a 21-item self-report measure for assessing fear associated with various air travel situations. Fear elicited by each situation was rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84. In the original FFS (Haug et al., 1987) Cronbach's alpha was .94 and retest reliability (at three months) was .86.
2 secondary outcomes
Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)
Time frame: up to 12 months
The Fear of flying scale (FFS; Haug et al., 1987)
Time frame: up to 12 months
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 13 Mar 2018.
- Background: PubMed 21177516Tortella-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.
- BackgroundBornas, X., Fullana, M.A., Tortella-Feliu, M., Llabrés, J. & García de la Banda, G. Computer-assisted therapy in the treatment of flight phobia: a case report. Cognitive and Behavioral Practice, 8, 234-240, 2001.
- BackgroundBornas, X., Tortella-Feliu, M. & Llabrés, J. Do all treatments work for flight phobia? Computer-assisted exposure versus a brief multicomponent nonexposure treatment. Psychotherapy Research, 16, 41-50, 2006.
- BackgroundBornas, X., Tortella-Feliu, M., García de la Banda, G., Fullana, M. A., & Llabrés, J. Validación factorial del Cuestionario de Miedo a Volar [Factorial validation of the Fear of Flying Questionnaire]. Análisis y Modificación de Conducta, 25, 885-907, 1999.
- Background: PubMed 18991528Botella C, Quero S, Banos RM, Garcia-Palacios A, Breton-Lopez J, Alcaniz M, Fabregat S. Telepsychology and self-help: the treatment of phobias using the internet. Cyberpsychol Behav. 2008 Dec;11(6):659-64. doi: 10.1089/cpb.2008.0012.
- Background: PubMed 26799907Quero S, Campos D, Riera Del Amo A, Breton-Lopez J, Tortella-Feliu M, Banos RM, Botella C. NO-FEAR Airlines: A Computer-aided Self-help Treatment for Flying Phobia. Stud Health Technol Inform. 2015;219:197-201.
- Derived from this study: 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.
- Derived from this study: PubMed 27544428Campos 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.
- Laboratory of Psychology and Technology of the University Jaume I (Labpsitec)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Soledad Quero, Full professor study director
University Jaume I, Castellon, Spain.
Juana Bretón, Assistant professor study director
University Jaume I, Castellon, Spain.
Daniel Campos, PhD student study chair
University Jaume I, Castellon, Spain
1 site in 1 country: see every site and its status.
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 7 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 13 Mar 2018. 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?
The Fear of Flying Questionnaire-II (FFQ-II; Bornas, Tortella-Feliu, García de la Banda, Fullana, & Llabrés, 1999). (time frame: up to 12 months). The study lists 2 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 NCT02298478, 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 13 Mar 2018.