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Emotional Processes in VR Exposure Treatment for Flight Phobia

NCT ID: NCT04213859

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-24

Study Completion Date

2023-09-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Fear of Flying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality Exposure Therapy (VRET)

1. st stage: Participants will receive information about the study, complete measures of fear of flying and emotional variables, and undergo a diagnostic interview for flight phobia and additional disorders.
2. nd stage: During the week prior to treatment, participants will complete a brief measure of emotion-related variables every evening at a fixed time (08:00 pm).
3. rd stage: Participants will receive therapy for fear of flying using a Virtual Reality (VR) simulator. Therapy sessions will be held once a week during 4 weeks. Participants will complete a brief measure of emotion-related variables at a random time during the 12 hours before the therapy session at a random time during the 12 hours after the therapy session. This will occur for every therapy session.
4. th stage: After treatment, participants will complete measures of fear of flying and emotional variables.

Group Type EXPERIMENTAL

VRET - Virtual Reality Exposure Therapy

Intervention Type 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).

control

1. st stage: Participants will receive information about the study, complete measures of fear of flying and emotional variables, and undergo a diagnostic interview for flight phobia and additional disorders.
2. nd stage: During five weeks no therapy will be administered. Participants will fill questionnaires as follows: During the first week, participants will complete emotional measures every evening at a fixed time (08:00 pm)
3. rd stage: During each of the following 4 weeks, participants will complete two emotional measures during a 24 hour period.
4. th stage: Participants will complete measures of fear of flying and emotional variables.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VRET - Virtual Reality Exposure Therapy

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* diagnosis of Flight phobia based on a structured interview
* possession of a smartphone with an active data plan

Exclusion Criteria

* cardiovascular disease
* neurological disorders and history of epilepsy
* psychosis
* major depression
* suicidal behavior
* substance abuse.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Idan Moshe Aderka

OTHER

Sponsor Role lead

Responsible Party

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Idan Moshe Aderka

Ph.D. Senior Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Asaf Caspi, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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6557-19-SMC

Identifier Type: -

Identifier Source: org_study_id