Anxiety Clinical Trial
Official title:
Virtual Reality Exposure Therapy for Fear of Flying: Protocol for a Randomized Controlled Trial
This study aims to assess whether adding vibrotactile stimulation to visual and auditory stimulation increases the efficacy of VRET for FoF treatment. Eighty-four participants (18-65 years old) will be assigned to one of three intervention arms, namely the VRET with multimodal feedback (visual, auditory, and vibrotactile; VRET-M), the VRET with bimodal feedback (visual and auditory; VRET-B), or the imagery exposure treatment (IET) without sensory feedback. FoF-related symptoms (primary outcomes) will be measured administering the Fear of Flying Questionnaire-II (QPV-II), the Fear of Flying Scale (FFS), and the Visual Analogic Scale (VAS-A) before and after eight sessions of treatment, and at six- and 12-month follow-ups. Anxiety and the sense of presence experienced during exposure sessions (secondary outcome measures: VAS-A and VAS-P) will also be assessed. It is expected that participants in the VRET-M group will report a further reduction of FoF-related symptomatology after the treatment and at follow-ups compared to participants in the VRET-B and IET groups. Likewise, participants in the VRET-M group are expected to show higher sense of presence levels during exposure sessions in comparison to participants in the VRET-B and IET groups. It is expected that the IET group will report the lowest level of sense of presence and the poorest outcome after treatment and at follow-ups.
Status | Not yet recruiting |
Enrollment | 84 |
Est. completion date | January 31, 2024 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Subjects who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5, American Psychiatric Association, APA, 2013) criteria for FoF. Exclusion Criteria: - Individuals with a diagnosis of panic disorder, obsessive-compulsive disorder, or psychotic disorder who have received psychotherapy for their FoF, have been taking prescribed medication for their FoF, or have experienced cardiorespiratory disease or an epilepsy attack will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Spain | Faculty of Psychology. Universitat de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
University of Barcelona |
Spain,
Rothbaum BO, Hodges L, Anderson PL, Price L, Smith S. Twelve-month follow-up of virtual reality and standard exposure therapies for the fear of flying. J Consult Clin Psychol. 2002 Apr;70(2):428-32. doi: 10.1037//0022-006x.70.2.428. — View Citation
Van Gerwen LJ, Spinhoven P, Van Dyck R. Behavioral and cognitive group treatment for fear of flying: a randomized controlled trial. J Behav Ther Exp Psychiatry. 2006 Dec;37(4):358-71. doi: 10.1016/j.jbtep.2006.05.002. Epub 2006 Jul 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS). | To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84. | Before the exposure treatment. | |
Primary | Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS). | To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84. | After eight sessions of treatment during eight weeks. | |
Primary | Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS). | To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84. | At 6 months follow-up after treatment termination. | |
Primary | Fear of Flying (FoF). Administering the Fear of Flying Questionnaire-II (QPV-II) and the Fear of Flying Scale (FFS). | To what extend I feel fear about flying by plane? The QPV-II is rated from on a 10-point scale (0 = absence of anxiety, 10 = extreme anxiety) with scores ranging from 0 to 300. The FFS is rated on a 5-point scale (0 = not at all, 4 = very much), with scores ranging from 0 to 84. | At 12 months follow-up after treatment termination. | |
Primary | Anxiety. Administering a Visual Analogue Scale (VAS-A). | To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety). | Before the exposure treatment. | |
Primary | Anxiety. Administering a Visual Analogue Scale (VAS-A). | To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety). | After eight sessions of treatment during eight weeks. | |
Primary | Anxiety. Administering a Visual Analogue Scale (VAS-A). | To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety). | At 6 months follow-up after treatment termination. | |
Primary | Anxiety. Administering a Visual Analogue Scale (VAS-A). | To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety). | At 12 months follow-up after treatment termination. | |
Secondary | Anxiety. Administering a Visual Analogue Scale (VAS-A). | To what extend I feel anxious now? measured from 0 (absence of anxiety) to 10 (extreme anxiety). | Before each exposure session. | |
Secondary | Anxiety. Administering a Visual Analogue Scale (VAS-A). | To what extend I feel anxious now? measured from 0 (absence of anxiety) to 10 (extreme anxiety). | Every 2 minutes during each exposure session of 60 minutes. | |
Secondary | Anxiety. Administering a Visual Analogue Scale (VAS-A). | To what extend I feel anxious now? measured from 0 (absence of anxiety) to 10 (extreme anxiety). | After eight sessions of treatment during eight weeks. | |
Secondary | Sense of Presence. Administering the Visual Analogue Scale (VAS-P). | To what extend I feel present now? measured from 0 (absence of sense of presence) to 10 (extreme sense of presence). | Every 2 minutes during each exposure session of 60 minutes. |
Status | Clinical Trial | Phase | |
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