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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of an Internet-based Treatment for Flying Phobia: A Randomized Controlled Trial

Conditions
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Flying Phobia

Intervention / Treatment
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* Behavioral: NO-FEAR Airlines


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group without support by the therapist<br>Intervention group that do the NO-FEAR Airlines program and does not receive support by the therapist. | Behavioral: NO-FEAR Airlines<br>* 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.<br>* Other names: Internet-based treatment for flying phobia;|
| Experimental: Group with support by the therapist<br>Intervention group that do the NO-FEAR Airlines program and receives support by the therapist (a brief weekly five-minutes call). | Behavioral: NO-FEAR Airlines<br>* 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.<br>* Other names: Internet-based treatment for flying phobia;|
| Other: Waiting list control group<br>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). | Behavioral: NO-FEAR Airlines<br>* 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.<br>* Other names: Internet-based treatment for flying phobia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-help, Computer-aided Treatment, Internet, Flying phobia, minimal contact therapies, Cognitive-Behavioural Treatment, Waiting list control group