NCT02298478

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

November 3, 2014

Last Update Submit

March 12, 2018

Conditions

Keywords

Self-helpComputer-aided TreatmentInternetFlying phobiaminimal contact therapiesCognitive-Behavioural TreatmentWaiting list control group

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

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

    up to 12 months

  • The Fear of flying scale (FFS; Haug et al., 1987)

    up to 12 months

Other Outcomes (3)

  • The Patient improvement Scale (Adapted from the Clinical Global Impression scale, CGI; Guy, 1976).

    up to 12 months

  • Treatment Preferences Questionnaire (Labpsitec, 2015)

    up to 12 months

  • Qualitative interview (Labpsitec, 2015).

    up to 12 months

Study Arms (3)

Group without support by the therapist

EXPERIMENTAL

Intervention group that do the "NO-FEAR Airlines" program and does not receive support by the therapist.

Behavioral: NO-FEAR Airlines

Group with support by the therapist

EXPERIMENTAL

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

Waiting list control group

OTHER

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

Interventions

"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.

Also known as: SIN MIEDO Airlines, Computer-aided Self-help Treatment for Flying Phobia, Internet-based treatment for flying phobia
Group with support by the therapistGroup without support by the therapistWaiting list control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Jaume I

Castellon, Castellon, 12006, Spain

Location

Related Publications (8)

  • 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: 21177516BACKGROUND
  • Bornas, X., Fullana, M.A., Tortella-Feliu, M., Llabrés, J. & García de la Banda, G. Computer-assisted therapy in the treatment of flight phobia: a case report. Cognitive and Behavioral Practice, 8, 234-240, 2001.

    BACKGROUND
  • Bornas, X., Tortella-Feliu, M. & Llabrés, J. Do all treatments work for flight phobia? Computer-assisted exposure versus a brief multicomponent nonexposure treatment. Psychotherapy Research, 16, 41-50, 2006.

    BACKGROUND
  • Bornas, X., Tortella-Feliu, M., García de la Banda, G., Fullana, M. A., & Llabrés, J. Validación factorial del Cuestionario de Miedo a Volar [Factorial validation of the Fear of Flying Questionnaire]. Análisis y Modificación de Conducta, 25, 885-907, 1999.

    BACKGROUND
  • Botella C, Quero S, Banos RM, Garcia-Palacios A, Breton-Lopez J, Alcaniz M, Fabregat S. Telepsychology and self-help: the treatment of phobias using the internet. Cyberpsychol Behav. 2008 Dec;11(6):659-64. doi: 10.1089/cpb.2008.0012.

    PMID: 18991528BACKGROUND
  • Quero S, Campos D, Riera Del Amo A, Breton-Lopez J, Tortella-Feliu M, Banos RM, Botella C. NO-FEAR Airlines: A Computer-aided Self-help Treatment for Flying Phobia. Stud Health Technol Inform. 2015;219:197-201.

    PMID: 26799907BACKGROUND
  • Campos D, Breton-Lopez J, Botella C, Mira A, Castilla D, Mor S, Banos R, Quero S. Efficacy of an internet-based exposure treatment for flying phobia (NO-FEAR Airlines) with and without therapist guidance: a randomized controlled trial. BMC Psychiatry. 2019 Mar 6;19(1):86. doi: 10.1186/s12888-019-2060-4.

  • 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.

Related Links

MeSH Terms

Conditions

Aerophobia

Study Officials

  • Soledad Quero, Full professor

    University Jaume I, Castellon, Spain.

    STUDY DIRECTOR
  • Juana Bretón, Assistant professor

    University Jaume I, Castellon, Spain.

    STUDY DIRECTOR
  • Daniel Campos, PhD student

    University Jaume I, Castellon, Spain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 24, 2014

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations