Efficacy of an Internet-based Treatment for Flying Phobia: NO-FEAR Airlines
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMarch 13, 2018
March 1, 2018
2 years
November 3, 2014
March 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
up to 12 months
Secondary Outcomes (2)
Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)
up to 12 months
The Fear of flying scale (FFS; Haug et al., 1987)
up to 12 months
Other Outcomes (3)
The Patient improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).
up to 12 months
Treatment Preferences Questionnaire (Labpsitec, 2015)
up to 12 months
Qualitative interview (Labpsitec, 2015).
up to 12 months
Study Arms (3)
Group without support by the therapist
EXPERIMENTALIntervention group that do the "NO-FEAR Airlines" program and does not receive support by the therapist.
Group with support by the therapist
EXPERIMENTALIntervention group that do the "NO-FEAR Airlines" program and receives support by the therapist (a brief weekly five-minutes call).
Waiting list control group
OTHERControl 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).
Interventions
"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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Jaume I
Castellon, Castellon, 12006, Spain
Related Publications (8)
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.
PMID: 21177516BACKGROUNDBornas, 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.
BACKGROUNDBotella 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.
PMID: 18991528BACKGROUNDQuero 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.
PMID: 26799907BACKGROUNDCampos 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: 30841930DERIVEDCampos 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.
PMID: 27544428DERIVED
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Soledad Quero, Full professor
University Jaume I, Castellon, Spain.
- STUDY DIRECTOR
Juana Bretón, Assistant professor
University Jaume I, Castellon, Spain.
- STUDY CHAIR
Daniel Campos, PhD student
University Jaume I, Castellon, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2014
First Posted
November 24, 2014
Study Start
September 1, 2015
Primary Completion
September 1, 2017
Study Completion
October 1, 2017
Last Updated
March 13, 2018
Record last verified: 2018-03