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An Internet-based Treatment for Flying Phobia

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 Specific Phobia, Computer-Assisted Exposure, Self-help, Internet-based Therapy, Sense of presence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be between 18-65 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.
  • 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 on Axis I: abuse or dependence of alcohol or other substances, psychotic disorder, dementia, bipolar disorder.
  • Severe Personality Disorder.
  • Presence of depressive symptomatology, suicidal ideation or plan.
  • Presence of heart disease.
  • Pregnant women (from the fourth month).

Sites / Locations

  • Universitat Jaume I

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

"NO-FEAR Airlines" program with still images

"NO-FEAR Airlines" program with still and navigable images

Waiting list control group

Arm Description

Intervention group that uses "NO-FEAR Airlines" program with still images to carry out the exposure.

Intervention group that uses "NO-FEAR Airlines" program with still and navigable images to carry out the exposure.

Participants of this group are able to access "NO-FEAR Airlines" program after 6 weeks of waiting period. After that period, those participants still interested in receiving assistance are randomly assigned to one of two intervention conditions (only still images or still + navigable images).

Outcomes

Primary Outcome Measures

Expectations Scale and Satisfaction Scale (adapted from Borkovec & Nau, 1972)
This self-report inventory measures the patients' expectations before they start the treatment and after they receive a brief explanation about the intervention and their experimental condition. The same questions have to be answered when the patient completes the treatment in order to assess satisfaction. The 6 items are rated from 1 ("Not at all") to 10 ("Highly").
Preferences questionnaire
This questionnaire collects the patient's preferences regarding the two types of images included in this study (navigable and still images) through 5 dichotomous questions where they have to choose one of the two conditions. Participants will answer these questions before the treatment and before knowing the condition to which they are allocated (after the characteristics of each type of image are explained) and after they have completed the treatment (and after seeing a short video showing the image condition they did not receive).
Qualitative Interview
This interview assesses the participant's opinion of the intervention program after finishing it. The interview contains 13 items that the patient has to rate on a scale ranging from 1 ("very little") to 5 ("very much") and explain the reasons for their rating on each question. There are also two open questions where the participants have to give their overall opinion about the intervention program and the program images. In this interview, the perceived sense of presence and reality judgement in each scenario will also be assessed.

Secondary Outcome Measures

Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)
Participants assessed their fear, avoidance and belief in catastrophic thought on a scale ranging from 0 ("No fear at all," "I never avoid") to 10 ("Severe fear," "I always avoid") for situations related with flying.
The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994).
The clinician rates the severity of the patient's phobia on a scale from 0 to 8, where 0 = symptom free and 8 = extremely severe.
Patient's Improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).
One item on the CGI scale was adapted in order to assess the level of improvement achieved by the patient (compared to the baseline) on a 7-point scale (1 "much worse" to 7 "much better"). This scale is answered by the patient.
Fear of Flying Questionnaire (FFQ-II; Bornas et al, 1999)
The FFQ is a 30-item self-report questionnaire that assesses the anxiety the person feels in different situations of the flight process: anxiety during the flight, anxiety experienced getting on the plane, and anxiety experienced due to the observation of neutral or unpleasant flying-related situations. For each item, respondents rate their degree of discomfort associated with the situation on a scale from 1 to 9 (1 = not at all, 9 = very much). Scores range from 30 to 270. Internal consistency was α = .97, and test-retest reliability (15-day retest period) was r = .92 (Bornas et al. 1999).
Fear of Flying Scale (FFS; Haug et al., 1987).
The FFS is a 21-item self-report measure to assess fear in different flying situations. Fear elicited by each situation was rated on a 4-point scale (1= not at all, 4 = very much), with scores ranging from 21 to 84. The original FFS reported a Cronbach's alpha of .94 and retest reliability (after a three-month period) of .86 (Haug et al., 1987).

Full Information

First Posted
January 8, 2019
Last Updated
June 25, 2021
Sponsor
Universitat Jaume I
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1. Study Identification

Unique Protocol Identification Number
NCT03900559
Brief Title
An Internet-based Treatment for Flying Phobia
Official Title
An Internet-based Treatment for Flying Phobia Using 360º Images: A Feasibility Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Flying phobia (FP) is one of the most prevalent phobias in our society. However, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention, drop out when they are informed about the intervention procedure, or have problems accessing these therapies. The aim of the present study is to conduct a feasibility pilot with NO-FEAR Airlines ICBT (Campos et al., 2016) using two types of images in the exposure scenarios (still images vs 360º navigable images). A secondary aim is to explore the potential effectiveness of the two active treatment arms compared to a waiting list control group. Finally, we will explore the role of navigable images compared to the still images in the level of anxiety, sense of presence, and reality judgment in the exposure scenarios and whether the aforementioned variables mediate in treatment efficacy. Regarding the main aim of this study, we hypothesize that both treatment conditions will be well accepted by the participants, but participants will prefer 360º images over still images.
Detailed Description
Flying phobia (FP) is one of the most prevalent phobias in our society. Around 25% of the population that flies experiences intense distress during the flight; around 10% of the general population does not fly due to intense fear and 20% of people depend on alcohol or tranquilizers to overcome the fear of flying. In vivo exposure is the most effective psychological treatment for specific phobias. However, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention, drop out when they are informed about the intervention procedure, or they have problems to access these therapies. Information and Communication Technologies (ICTs) can improve treatment adherence and acceptance. Particularly, computerized programs offer remarkable advantages such as a reduction in direct therapeutic contact time, the possibility of standardizing treatment as much as possible with a steep exposure gradient, the low cost and, maybe most importantly, access to patients who would not be very willing to subject themselves to in vivo exposure. The application of cognitive-behavioural procedures such as exposure through interactive computer programs is especially recommended. On the other hand, it is important to explore the role of the degree of immersion and sense of presence in the psychological treatments with iCBTs due to the contradictory conclusions that had been found in the literature. Therefore, it is expected that the present work advances in the knowledge in this field exploring these factors in an Internet-based self-applied treatment program for FP evaluating if a change in the exposure images used in the program NO-FEAR Airlines (Campos et al., 2016) will be feasible in a future RCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flying Phobia
Keywords
Specific Phobia, Computer-Assisted Exposure, Self-help, Internet-based Therapy, Sense of presence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"NO-FEAR Airlines" program with still images
Arm Type
Experimental
Arm Description
Intervention group that uses "NO-FEAR Airlines" program with still images to carry out the exposure.
Arm Title
"NO-FEAR Airlines" program with still and navigable images
Arm Type
Experimental
Arm Description
Intervention group that uses "NO-FEAR Airlines" program with still and navigable images to carry out the exposure.
Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
Participants of this group are able to access "NO-FEAR Airlines" program after 6 weeks of waiting period. After that period, those participants still interested in receiving assistance are randomly assigned to one of two intervention conditions (only still images or still + navigable images).
Intervention Type
Behavioral
Intervention Name(s)
NO-FEAR Airlines
Intervention Description
"NO-FEAR Airlines" is an Internet-based self-applied treatment program that allows people with Flying Phobia the exposure to images and sounds related to their phobic fears on a standard personal computer. The treatment can be totally self-applied. "NO-FEAR Airlines" contains 6 scenarios related to the flight process: (1) flight preparation, (2) airport, (3) boarding and taking off, (4) the central part of the flight, (5) the airplane's descent, approach to the runway, and landing, (6) sequences with images and auditory stimuli related to plane crashes.
Primary Outcome Measure Information:
Title
Expectations Scale and Satisfaction Scale (adapted from Borkovec & Nau, 1972)
Description
This self-report inventory measures the patients' expectations before they start the treatment and after they receive a brief explanation about the intervention and their experimental condition. The same questions have to be answered when the patient completes the treatment in order to assess satisfaction. The 6 items are rated from 1 ("Not at all") to 10 ("Highly").
Time Frame
Up to 12 months
Title
Preferences questionnaire
Description
This questionnaire collects the patient's preferences regarding the two types of images included in this study (navigable and still images) through 5 dichotomous questions where they have to choose one of the two conditions. Participants will answer these questions before the treatment and before knowing the condition to which they are allocated (after the characteristics of each type of image are explained) and after they have completed the treatment (and after seeing a short video showing the image condition they did not receive).
Time Frame
Up to 12 months
Title
Qualitative Interview
Description
This interview assesses the participant's opinion of the intervention program after finishing it. The interview contains 13 items that the patient has to rate on a scale ranging from 1 ("very little") to 5 ("very much") and explain the reasons for their rating on each question. There are also two open questions where the participants have to give their overall opinion about the intervention program and the program images. In this interview, the perceived sense of presence and reality judgement in each scenario will also be assessed.
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, avoidance and belief in catastrophic thought on a scale ranging from 0 ("No fear at all," "I never avoid") to 10 ("Severe fear," "I always avoid") for situations related with flying.
Time Frame
Up to 12 months
Title
The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994).
Description
The clinician rates the severity of the patient's phobia on a scale from 0 to 8, where 0 = symptom free and 8 = extremely severe.
Time Frame
Up to 12 months
Title
Patient's Improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).
Description
One item on the CGI scale was adapted in order to assess the level of improvement achieved by the patient (compared to the baseline) 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
Fear of Flying Questionnaire (FFQ-II; Bornas et al, 1999)
Description
The FFQ is a 30-item self-report questionnaire that assesses the anxiety the person feels in different situations of the flight process: anxiety during the flight, anxiety experienced getting on the plane, and anxiety experienced due to the observation of neutral or unpleasant flying-related situations. For each item, respondents rate their degree of discomfort associated with the situation on a scale from 1 to 9 (1 = not at all, 9 = very much). Scores range from 30 to 270. Internal consistency was α = .97, and test-retest reliability (15-day retest period) was r = .92 (Bornas et al. 1999).
Time Frame
Up to 12 months
Title
Fear of Flying Scale (FFS; Haug et al., 1987).
Description
The FFS is a 21-item self-report measure to assess fear in different flying situations. Fear elicited by each situation was rated on a 4-point scale (1= not at all, 4 = very much), with scores ranging from 21 to 84. The original FFS reported a Cronbach's alpha of .94 and retest reliability (after a three-month period) of .86 (Haug et al., 1987).
Time Frame
Up to 12 months
Other Pre-specified Outcome Measures:
Title
Reality Judgement and Presence Questionnaire (RJPQ) (adapted from Baños, Quero, Salvador & Botella, 2007).
Description
This questionnaire is composed by 18 items to assess reality judgment and sense of presence. A 0-10 Likert scale is used to answer all items.
Time Frame
Up to 12 months
Title
Sense of presence and reality judgment
Description
When the exposure scenario is completed (anxiety level less than 3), the program will assess, on scales from 0 to 10, the extent to which the patients feel present in the situation and the extent to which they feel the situation is real
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be between 18-65 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. 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 on Axis I: abuse or dependence of alcohol or other substances, psychotic disorder, dementia, bipolar disorder. Severe Personality Disorder. Presence of depressive symptomatology, suicidal ideation or plan. Presence of heart disease. Pregnant women (from the fourth month).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soledad Quero, PhD
Organizational Affiliation
Universitat Jaume I
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cristina Botella, PhD
Organizational Affiliation
Universitat Jaume I
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sonia Mor, PhD Student
Organizational Affiliation
Universitat Jaume I
Official's Role
Study Chair
Facility Information:
Facility Name
Universitat Jaume I
City
Castellón De La Plana
State/Province
Castellón
ZIP/Postal Code
12006
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
Botella, C., Osma, J., García-Palacios, A., Quero, S., & Baños, R.M. (2004). Treatment of flying phobia using virtual reality: data from a 1-year follow-up using a multiple baseline design. Clinical Psychology and psychotherapy, 11, 311-323.
Results Reference
background
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
background
PubMed Identifier
29636613
Citation
Campos D, Mira A, Breton-Lopez J, Castilla D, Botella C, Banos RM, Quero S. The acceptability of an Internet-based exposure treatment for flying phobia with and without therapist guidance: patients' expectations, satisfaction, treatment preferences, and usability. Neuropsychiatr Dis Treat. 2018 Mar 28;14:879-892. doi: 10.2147/NDT.S153041. eCollection 2018.
Results Reference
background
PubMed Identifier
17927544
Citation
Garcia-Palacios A, Botella C, Hoffman H, Fabregat S. Comparing acceptance and refusal rates of virtual reality exposure vs. in vivo exposure by patients with specific phobias. Cyberpsychol Behav. 2007 Oct;10(5):722-4. doi: 10.1089/cpb.2007.9962.
Results Reference
background
Citation
Kazdin, A. E. (2015). Evidence-based psychotherapies II: changes in models of treatment and treatment delivery. South African Journal of Psychology, 45(1), 3-21.
Results Reference
background
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
PubMed Identifier
35242593
Citation
Mor S, Botella C, Campos D, Carlbring P, Tur C, Quero S. An internet-based treatment for flying phobia using 360 degrees images: A feasibility pilot study. Internet Interv. 2022 Feb 16;28:100510. doi: 10.1016/j.invent.2022.100510. eCollection 2022 Apr.
Results Reference
derived
PubMed Identifier
33936953
Citation
Mor S, Botella C, Campos D, Tur C, Castilla D, Soler C, Quero S. An Internet-based treatment for Flying Phobia using 360 degrees images: Study protocol for a feasibility pilot study. Internet Interv. 2021 Apr 6;24:100387. doi: 10.1016/j.invent.2021.100387. eCollection 2021 Apr.
Results Reference
derived

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An Internet-based Treatment for Flying Phobia

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