An Internet-based Treatment for Flying Phobia

NCT03900559 | Completed

• 1 other identifier: UJaumeI5
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Flying Phobia

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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").

  Up to 12 months

• 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).

  Up to 12 months

• 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.

  Up to 12 months

Secondary Outcomes (5)

• Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)

  Up to 12 months

• The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994).

  Up to 12 months

• Patient's Improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).

  Up to 12 months

• Fear of Flying Questionnaire (FFQ-II; Bornas et al, 1999)

  Up to 12 months

• Fear of Flying Scale (FFS; Haug et al., 1987).

  Up to 12 months

Other Outcomes (2)

• Reality Judgement and Presence Questionnaire (RJPQ) (adapted from Baños, Quero, Salvador & Botella, 2007).

  Up to 12 months

• Sense of presence and reality judgment

  Up to 12 months

Study Arms (3)

"NO-FEAR Airlines" program with still images

EXPERIMENTAL

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

Behavioral: NO-FEAR Airlines

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

EXPERIMENTAL

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

Behavioral: NO-FEAR Airlines

Waiting list control group

NO INTERVENTION

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).

Interventions

NO-FEAR Airlines BEHAVIORAL

"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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12006, Spain

Location

Related Publications (8)

• 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.

  BACKGROUND

• 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.

  PMID: 27544428 BACKGROUND

• 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.

  PMID: 29636613 BACKGROUND

• 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.

  PMID: 17927544 BACKGROUND

• 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.

  BACKGROUND

• 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: 21177516 BACKGROUND

• 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.

  PMID: 35242593 DERIVED

• 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.

  PMID: 33936953 DERIVED

MeSH Terms

Conditions

Aerophobia; Phobia, Specific

Study Officials

• Soledad Quero, PhD

  Universitat Jaume I

  STUDY DIRECTOR

• Cristina Botella, PhD

  Universitat Jaume I

  STUDY DIRECTOR

• Sonia Mor, PhD Student

  Universitat Jaume I

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: April 3, 2019
• Study Start: February 1, 2018
• Primary Completion: October 15, 2020
• Study Completion: May 1, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

ES (1)