An Internet-based Treatment for Flying Phobia

NCT ID: NCT03900559

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2021-05-01

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.

Conditions

Flying Phobia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

"NO-FEAR Airlines" program with still images

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

Group Type: EXPERIMENTAL

NO-FEAR Airlines

Intervention Type: 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

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

Group Type: EXPERIMENTAL

NO-FEAR Airlines

Intervention Type: 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.

Waiting list control group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NO-FEAR Airlines

"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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Jaume I

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soledad Quero, PhD

Role: STUDY_DIRECTOR

Universitat Jaume I

Cristina Botella, PhD

Role: STUDY_DIRECTOR

Universitat Jaume I

Sonia Mor, PhD Student

Role: STUDY_CHAIR

Universitat Jaume I

Locations

Universitat Jaume I

Castellon, Castellón, Spain

Countries

Spain

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 27544428 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29636613 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17927544 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 21177516 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35242593 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33936953 (View on PubMed)

Other Identifiers

UJaumeI5

Identifier Type: -

Identifier Source: org_study_id