Clinical trial NCT03900559: 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
Overall status: COMPLETED
Phase: NA
Conditions: Flying Phobia
Keywords: Specific Phobia
Computer-Assisted Exposure
Self-help
Internet-based Therapy
Sense of presence
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Expectations Scale and Satisfaction Scale (adapted from Borkovec & Nau, 1972)
timeFrame: Up to 12 months
measure: Preferences questionnaire
timeFrame: Up to 12 months
measure: Qualitative Interview
timeFrame: Up to 12 months
Secondary outcomes:
measure: Fear and Avoidance Scales (adapted from Marks & Mathews, 1979)
timeFrame: Up to 12 months
measure: The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994).
timeFrame: Up to 12 months
measure: Patient's Improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).
timeFrame: Up to 12 months
measure: Fear of Flying Questionnaire (FFQ-II; Bornas et al, 1999)
timeFrame: Up to 12 months
measure: Fear of Flying Scale (FFS; Haug et al., 1987).
timeFrame: Up to 12 months
Other outcomes:
measure: Reality Judgement and Presence Questionnaire (RJPQ) (adapted from Baños, Quero, Salvador & Botella, 2007).
timeFrame: Up to 12 months
measure: Sense of presence and reality judgment
timeFrame: Up to 12 months
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
Study officials:
affiliation: Universitat Jaume I
name: Soledad Quero, PhD
role: STUDY_DIRECTOR
affiliation: Universitat Jaume I
name: Cristina Botella, PhD
role: STUDY_DIRECTOR
affiliation: Universitat Jaume I
name: Sonia Mor, PhD Student
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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: 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.
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.