Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Participants who meet the inclusion criteria will be invited to participate in the initial treatment session. They will be also required to purchase a flight ticket during the six months after the end of the treatment. Participants will be treated weekly for eight individual sessions. While the first two sessions involve preparation and training, exposure will be conducted between the third and eighth session. The exposure sessions' structure and content will be the same in all conditions. Nevertheless, the VRET-M group will experience vibrotactile cues, while the VRET-B group will not. Furthermore, the IET group will experience its own subjective imagined environment without any external stimulation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Virtual Reality Exposure Treatment (VRET-M) | Experimental | VRET with multimodal feedback including visual, auditory and vibrotactile cues. |
|
| Bimodal Virtual Reality Exposure Treatment (VRET-B) | Active Comparator | VRET with bimodal feedback including visual and auditory cues. |
|
| Imagery Exposure Treatment (IET) | Active Comparator | Imagery exposure treatment without sensory cues. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality-based exposure treatment with multimodal feedback (VRET-M) | Behavioral | The VRET-M group will experience visual, auditive and vibrotactile cues in the exposure sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Anxiety. Administering a Visual Analogue Scale (VAS-A). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Anxiety. Administering a Visual Analogue Scale (VAS-A). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José María MR Ribé Viñes, MD | Contact | 676022376 | +34 | jmribev@gmail.com |
| Marta MS Ferrer Garcia, PhD | Contact | 933125114 | +34 | martaferrerg@ub.edu |
| Name | Affiliation | Role |
|---|---|---|
| José MR Gutiérrez Maldonado, PhD | Senior PhD Supervisor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Psychology. Universitat de Barcelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16828460 | Background | 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. | |
| 11952201 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants 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).
Not provided
Not provided
Not-blinded study protocol.
Not provided
| Virtual reality-based exposure treatment with bimodal feedback (VRET-B) | Behavioral | The VRET-B group will experience visual and auditive cues in the exposure sessions. |
|
| Imagery exposure treatment (IET) | Behavioral | The IET group will experience its own subjective imagined environment without any external stimulation. |
|
To what extend I feel anxious about flying by plane? measured from 0 (absence of anxiety) to 10 (extreme anxiety). |
| Before the exposure treatment. |
| 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. |
| 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. |
| 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. |
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. |
| 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. |
| 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. |
| ID | Term |
|---|---|
| C000719189 | Aerophobia |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided