Clinical trial NCT02298478: 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
Overall status: COMPLETED
Phase: NA
Conditions: Flying Phobia
Keywords: Self-help
Computer-aided Treatment
Internet
Flying phobia
minimal contact therapies
Cognitive-Behavioural Treatment
Waiting list control group
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Fear of Flying Questionnaire-II (FFQ-II; Bornas, Tortella-Feliu, García de la Banda, Fullana, & Llabrés, 1999).
timeFrame: up to 12 months
measure: The Fear of Flying scale (FFS; Haug et al. (1987)
timeFrame: up to 12 months
Secondary outcomes:
measure: Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)
timeFrame: up to 12 months
measure: The Fear of flying scale (FFS; Haug et al., 1987)
timeFrame: up to 12 months
Other outcomes:
measure: The Patient improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).
timeFrame: up to 12 months
measure: Treatment Preferences Questionnaire (Labpsitec, 2015)
timeFrame: up to 12 months
measure: Qualitative interview (Labpsitec, 2015).
timeFrame: up to 12 months
Locations:
city: Castellon
country: Spain
facility: University Jaume I
Study officials:
affiliation: University Jaume I, Castellon, Spain.
name: Soledad Quero, Full professor
role: STUDY_DIRECTOR
affiliation: University Jaume I, Castellon, Spain.
name: Juana Bretón, Assistant professor
role: STUDY_DIRECTOR
affiliation: University Jaume I, Castellon, Spain
name: Daniel Campos, PhD student
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.