search
Back to results

Efficacy of an Internet-based Treatment for Flying Phobia: NO-FEAR Airlines

Primary Purpose

Flying Phobia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
NO-FEAR Airlines
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flying Phobia focused on measuring Self-help, Computer-aided Treatment, Internet, Flying phobia, minimal contact therapies, Cognitive-Behavioural Treatment, Waiting list control group

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University Jaume I

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Group without support by the therapist

Group with support by the therapist

Waiting list control group

Arm Description

Intervention group that do the "NO-FEAR Airlines" program and does not receive support by the therapist.

Intervention group that do the "NO-FEAR Airlines" program and receives support by the therapist (a brief weekly five-minutes call).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 3, 2014
Last Updated
March 12, 2018
Sponsor
Universitat Jaume I
search

1. Study Identification

Unique Protocol Identification Number
NCT02298478
Brief Title
Efficacy of an Internet-based Treatment for Flying Phobia: NO-FEAR Airlines
Official Title
Efficacy of an Internet-based Treatment for Flying Phobia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flying Phobia
Keywords
Self-help, Computer-aided Treatment, Internet, Flying phobia, minimal contact therapies, Cognitive-Behavioural Treatment, Waiting list control group

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group without support by the therapist
Arm Type
Experimental
Arm Description
Intervention group that do the "NO-FEAR Airlines" program and does not receive support by the therapist.
Arm Title
Group with support by the therapist
Arm Type
Experimental
Arm Description
Intervention group that do the "NO-FEAR Airlines" program and receives support by the therapist (a brief weekly five-minutes call).
Arm Title
Waiting list control group
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
NO-FEAR Airlines
Other Intervention Name(s)
SIN MIEDO Airlines, Computer-aided Self-help Treatment for Flying Phobia, Internet-based treatment for flying phobia
Intervention Description
"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.
Primary Outcome Measure Information:
Title
The Fear of Flying Questionnaire-II (FFQ-II; Bornas, Tortella-Feliu, García de la Banda, Fullana, & Llabrés, 1999).
Description
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.
Time Frame
up to 12 months
Title
The Fear of Flying scale (FFS; Haug et al. (1987)
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)
Description
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.
Time Frame
up to 12 months
Title
The Fear of flying scale (FFS; Haug et al., 1987)
Description
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.
Time Frame
up to 12 months
Other Pre-specified Outcome Measures:
Title
The Patient improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).
Description
One item of the CGI scale was adapted in order to assess the level of improvement achieved by the patient (compared to the baseline status) on a 7-point scale (1 "much worse" to 7 "much better"). This scale is answered by the patient.
Time Frame
up to 12 months
Title
Treatment Preferences Questionnaire (Labpsitec, 2015)
Description
This instrument was specifically developed for this research. It is composed by 5 questions to measure participant's preferences regarding both treatment conditions included in this study (with and without therapist support): (1) Preference (2) Subjective effectiveness 3) Logical (4) Subjective aversion (5) Recommendation. Questions are composed by two response options in accordance with the two treatment conditions. This scale will be completed before participants know the treatment condition assigned and after treatment.
Time Frame
up to 12 months
Title
Qualitative interview (Labpsitec, 2015).
Description
This interview was also specifically developed for this research. It contains 11 items in order to assess participants' opinion regarding NO-FEAR Airlines program and about the support received. The interview includes questions that are rated on 1 to 5 scales (1= very little; 5= very much) and Dichotomous Questions ("Yes" or "No"). Additionally, options to extend the qualitative participants' responses are available.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soledad Quero, Full professor
Organizational Affiliation
University Jaume I, Castellon, Spain.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juana Bretón, Assistant professor
Organizational Affiliation
University Jaume I, Castellon, Spain.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel Campos, PhD student
Organizational Affiliation
University Jaume I, Castellon, Spain
Official's Role
Study Chair
Facility Information:
Facility Name
University Jaume I
City
Castellon
ZIP/Postal Code
12006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21177516
Citation
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.
Results Reference
background
Citation
Bornas, 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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18991528
Citation
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.
Results Reference
background
PubMed Identifier
26799907
Citation
Quero 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.
Results Reference
background
PubMed Identifier
30841930
Citation
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.
Results Reference
derived
PubMed Identifier
27544428
Citation
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.
Results Reference
derived
Links:
URL
http://www.labpsitec.uji.es
Description
Laboratory of Psychology and Technology of the University Jaume I (Labpsitec)
URL
http://www.fobiavolar.es/
Description
NO-FEAR Airlines website

Learn more about this trial

Efficacy of an Internet-based Treatment for Flying Phobia: NO-FEAR Airlines

We'll reach out to this number within 24 hrs