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Comparison of the Effectiveness of Virtual Reality Exposure Therapy with Eye Movement Desensitization and Reprocessing Therapy on Symptoms of Acrophobia and Anxiety Sensitivity in Adolescent Girls

Protocol summary

Study aim
The purpose of this study is to compare the effectiveness of Virtual Reality Exposure Therapy (VRET) with Eye Movement Desensitization and Reprocessing (EMDR) therapy on symptoms of acrophobia and anxiety sensitivity.
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 2 on 45 patients. A table of random numbers was used for randomization.
Settings and conduct
Following randomization and assignment of individuals in the study groups, patients are treated approximately twice a week using VRET or EMDR. This study is performed in the psychology department of Persian Gulf University.
Participants/Inclusion and exclusion criteria
participants: 45 female students. Inclusion criteria: a score greater than or equal to 50, fulfilling all diagnostic criteria of specific phobia (i.e., acrophobia) based on the SCID-5, and providing written informed consent for participation in the study by participants and their parents. Exclusion criteria: patients with hearing or visual impairment such as stereoscopy blindness or nystagmus, presence of any other mental disorders as assessed using the structured clinical interview, presence of specific physiological illnesses such as heart, lung and respiratory diseases, epilepsy and seizures, developmental or intellectual disability, cognitive impairment, known balance disorders such as vertigo, dependent on alcohol or drugs, other current psychological treatment.
Intervention groups
VRE (n=15), EMDR therapy (n=15), and the waiting list control condition (n=15).
Main outcome variables
Symptoms of Acrophobia, Anxiety Sensitivity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210213050343N1
Registration date: 2021-07-12, 1400/04/21
Registration timing: retrospective

Last update: 2021-07-12, 1400/04/21
Update count: 0
Registration date
2021-07-12, 1400/04/21
Registrant information
Name
Parisa Azimisefat
Name of organization / entity
Persian Golf University
Country
Iran (Islamic Republic of)
Phone
+98 77 3122 2078
Email address
parisa0730@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
Expected recruitment end date
2021-06-27, 1400/04/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Virtual Reality Exposure Therapy with Eye Movement Desensitization and Reprocessing Therapy on Symptoms of Acrophobia and Anxiety Sensitivity in Adolescent Girls
Public title
Comparison of the Effectiveness of Virtual Reality Exposure Therapy with Eye Movement Desensitization and Reprocessing Therapy on Symptoms of Acrophobia and Anxiety Sensitivity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A score greater than or equal to 50 in the Acrophobia Questionnaire fulfillment of all specific phobia diagnostic criteria (eg, acrophobia) based on SCID-5 submission of written consent for participation in the study by participants and their parents Age 14 to 18 years
Exclusion criteria:
patients with hearing or visual impairment such as stereoscopy blindness or nystagmus presence of any other mental disorders as assessed using the structured clinical interview presence of specific physiological illnesses such as heart, lung and respiratory diseases, epilepsy and seizures developmental or intellectual disability, cognitive impairment, known balance disorders such as vertigo, dependent on alcohol or drugs other current psychological treatment
Age
From 14 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
All patients who give consent for participation and who fulfilling the inclusion criteria are randomized using a random number table. In the random number table, a special code was assigned to each patient, respectively. To randomly assign each patient to the groups, the researcher randomly selected individuals from a table point in a row or direction: VRE (n=15), EMDR therapy (n=15), and the waiting list control condition (n=15).
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blind study in that the researcher and participants are aware of the allocating intervention, but the data analyst and the person conducting the assessments are blind to the specific participant’s group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr Province University of Medical Sciences
Street address
Bushehr, Moallem St., in front of Friday prayer place, Bushehr University of Medical Sciences and Health Services
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.BPUMS.REC.1400.036

Health conditions studied

1

Description of health condition studied
Fear of Heights or Acrophobia
ICD-10 code
F40.241
ICD-10 code description
Acrophobia

Primary outcomes

1

Description
Acrophobia: Severe anxiety when standing in high places or watching other people in such situations causes severe fear in people with a phobia. As in other fears, one is fully aware of the irrationality and irrationality of one's fears but nevertheless cannot overcome them. These people try to avoid facing such situations, so that avoidance may have a negative impact on their personal or social life.Anxiety Sensitivity: It is a structure of individual differences in which the individual is afraid of the physical symptoms associated with anxiety arousal (increased heart rate, shortness of breath, dizziness) and basically arises from the belief that these symptoms have potentially harmful consequences. Social, cognitive, and physical leads.
Timepoint
One week before the intervention and one week after the last intervention session
Method of measurement
Acrophobia Questionnaire and Anxiety Sensitivity Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: VRET is conducte by using a Desktop Computer with specifications; Graphics Card: ASUS NVIDIA GEFORCE GTX 1060 6GB GDDR5, CPU: Core i7-4790 (8M Cache, up to 4.00 GHz), RAM: 8 GB DDR4, and an Oculus Rift Dk2 Virtual Reality Headset. These tools make it possible to create a virtual environment and to provide the VR stimuli to the patient in a safe environment. Patients in the VRET condition are confronte with one VR scenario in each session. In the final session, all VR scenarios are presente one after another. VRET intervention in each session include two consecutive phases: a training phase and an experimental phase.
Category
Behavior

2

Description
Intervention group: EMDR therapy in the present study IS based on the standard protocol for specific phobias, consisting of eight steps perform over six one-hour sessions.
Category
Behavior

3

Description
Control group: They are assessed one week before the start of treatment and one week after the end of the last treatment session using acrophobia and anxiety sensitivity questionnaires.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Bushehr Education Department
Full name of responsible person
Alimorad Karami
Street address
Shahid Chamran Boulevard - Shahid Avini Street
City
Bushehr
Province
Boushehr
Postal code
7515883979
Phone
+98 77 3333 3509
Fax
+98 77 3333 1583
Email
burva@medu.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Persian Gulf University
Full name of responsible person
Soran Rajabi
Street address
Persian Gulf Street, Persian Gulf University
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2710
Email
sooranrajabi@pgu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Persian Gulf University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Persian Gulf University
Full name of responsible person
Parisa Azimisefat
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Persian Gulf Street, Persian Gulf University
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2710
Email
parisa0730@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Persian Gulf University
Full name of responsible person
Soran Rajabi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Persian Gulf Street, Persian Gulf University
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2710
Email
sooranrajabi@pgu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Persian Golf University
Full name of responsible person
Parisa Azimisefat
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Persian Golf Street
City
Boushehr
Province
Boushehr
Postal code
6719967476
Phone
+98 83 3838 8755
Fax
Email
parisa0730@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data from participants' responses to acrophobia and anxiety sensitivity questionnaires in pre-test and post-test were analyzed using SPSS software, and the results, without mentioning the names of the participants, were shared as study results.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data of this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data of this study will be provided for use by researchers in review or comparative studies.
From where data/document is obtainable
Parisa Azimisefat Department of Psychology, Persian Gulf University, Bushehr, Iran. parisa0730@gmail.com or parisa.azimi@mehr.pgu.ac.ir +989184025128
What processes are involved for a request to access data/document
The applicant provides information about their application via email. Up to two weeks after the request, if accepted, documents or data files will be sent.
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