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This study will assess emotional processes and their relation to treatment outcomes during Virtual reality exposure therapy for Flight Phobia. The researchers hypothesize treatment outcomes will be associated with positive changes in emotional constructs
Emotional constructs and emotion regulation capacities play a central role in the severity of anxiety disorders and are directly related to treatment outcomes in different anxiety disorders. In this study we will examine the relation between positive and negative affect, emotion regulation, emotional instability, emotional differentiation, experiential avoidance and therapy outcomes in participants undergoing Virtual Reality Exposure Therapy for Flight Phobia. We assume that treatment outcomes will be positively related to changes in the regulation, management and experience of emotions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Exposure Therapy (VRET) | Experimental |
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| control | No Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRET - Virtual Reality Exposure Therapy | Behavioral | VRET will include 4 weekly 1-hour sessions over the course of 4 weeks. The treatment protocol is based on the Virtual Reality (VR) treatment manual guidelines (Rothbaum & Hodges, 1997,1999) and includes psychoeducation, anxiety management training, cognitive restructuring and exposure. The first therapy session focuses on creating an individually-tailored conceptualization and treatment plan. Following this process, participant and therapist conduct a short introductory VR flight exposure simulation to familiarize the participant with the VRET apparatus. The VRET apparatus is an advanced, large-scale VR system that allows maximal immersion within the virtual environment. The second, third and fourth sessions include psychoeducation, relaxation training, cognitive restructuring and individually-tailored VR exposures (the therapist can manipulate the turbulence level and other flight-related variables to fit participants' fears and current progress). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in FAS (Flight Anxiety Situations Questionnaire) Scores | The Flight Anxiety Situations Questionnaire (Van Grewen, Spinhoven, Van-Dyck, & Dikstra, 1999) is a 32-item, 5-point Likert-scale (1= no anxiety to 5=overwhelming anxiety). The FAS evaluates flight-related anxiety in various situations. We used the total score of the FAS which ranges from 32 to 160 with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items. | Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks) |
| Changes in FAM (Flight Anxiety Modality Questionnaire) Scores | The Flight Anxiety Modality (FAM) questionnaire (Van Grewen et al. 1999) assesses somatic and cognitive aspects of Flight Phobia. It includes 18 items that are rated using a 5-point scale (1=not at all, 5=very intensely). We used the total score of the FAM which ranges from 18 to 90, with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items. | Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asaf Caspi, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | Israel | Israel |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Participants randomized to receive 4 weekly 1-hour sessions sessions of VRET (Virtual Reality Exposure Treatment). Number of participants: 42. |
| FG001 | Waitlist | Participants randomized to waitlist (did not receive treatment for 4 weeks). Number of participants: 42. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Participants randomized to receive 4 weekly 1-hour sessions sessions of VRET (Virtual Reality Exposure Treatment). Number of participants: 42. |
| BG001 | Waitlist | Participants randomized to waitlist (did not receive treatment for 4 weeks). Number of participants: 42. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in FAS (Flight Anxiety Situations Questionnaire) Scores | The Flight Anxiety Situations Questionnaire (Van Grewen, Spinhoven, Van-Dyck, & Dikstra, 1999) is a 32-item, 5-point Likert-scale (1= no anxiety to 5=overwhelming anxiety). The FAS evaluates flight-related anxiety in various situations. We used the total score of the FAS which ranges from 32 to 160 with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items. | Posted | Mean | Standard Deviation | Score on the scale | Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks) |
|
From enrollment to treatment completion, up to 10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Participants randomized to receive 4 weekly 1-hour sessions sessions of VRET (Virtual Reality Exposure Treatment). Number of participants: 42. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Idan M. Aderka | University of Haifa | +972-523403295 | iaderka@psy.haifa.ac.il |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2020 | Apr 28, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000719189 | Aerophobia |
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|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Waitlist | Participants randomized to waitlist (did not receive treatment for 4 weeks). Number of participants: 42. |
|
|
| Primary | Changes in FAM (Flight Anxiety Modality Questionnaire) Scores | The Flight Anxiety Modality (FAM) questionnaire (Van Grewen et al. 1999) assesses somatic and cognitive aspects of Flight Phobia. It includes 18 items that are rated using a 5-point scale (1=not at all, 5=very intensely). We used the total score of the FAM which ranges from 18 to 90, with higher values indicating more flight-related anxiety. Thus, higher values reflect worse outcomes, and lower values reflect better outcomes. The total score is obtained by summing all items. | Posted | Mean | Standard Deviation | Score on the scale | Two weeks prior to therapy and one week after last therapy session (therapy includes 4 weekly 1-hour sessions over the course of 4 weeks). |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Waitlist | Participants randomized to waitlist (did not receive treatment for 4 weeks). Number of participants: 42. | 0 | 42 | 0 | 42 | 0 | 42 |
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