Protocol summary

Study aim
Determination of efficacy of exposure therapy -based on virtual reality on reducing the physiological, cognitive-behavioral symptoms in people with social anxiety disorder
Design
According to the inclusion criteria, 20 patients with social anxiety disorder diagnosis based on social anxiety scale (SPIN) and structured clinical interview for dsm (SCID) are selected and randomly divided into two groups of intervention and control.
Settings and conduct
The statistical population of the study consisted of all students of Semnan University in the academic year of 97-96. These clients are volunteered and selected according to entry and exit criteria.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include age between 20 to 45, diagnostic criteria for social anxiety disorder based on DSM5 and exit criteria including history of certain mental and physical illnesses, alcohol or drug dependence
Intervention groups
Intervention group: A group of patients undergoing exposure therapy -based on virtual reality. Control group: A group of patients who do not undergo any intervention.
Main outcome variables
physiological symptoms, cognitive-behavioral symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171227038106N1
Registration date: 2018-03-04, 1396/12/13
Registration timing: registered_while_recruiting

Last update: 2018-03-04, 1396/12/13
Update count: 0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Hoda Nazemi
Name of organization / entity
Semnan university
Country
Iran (Islamic Republic of)
Phone
+98 23 3349 0213
Email address
hoda.nazemi@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigating the effect of environment based on virtual reality exposure therapy on psychological,cognitive_ behavioral symptoms and physiological symptoms of social anxiety disorder
Public title
design and evaluation environment based on virtual reality exposure therapy in treatment of social anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 20 to 45 years old that have a diagnosis criteria for social anxiety disorder acording to DSM5
Exclusion criteria:
alcoholism drug dependency History of physical or mental illness
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study has been used random allocation ruls.Randomized allocation in clinical trial studies refers to the process of dividing participants into different groups randomly. Randomization gives each participant equal chance for being placed in each of the groups.A number of students from Semnan University participated volunteering using public call. Of these, 20 people who received social anxiety disorder were randomly assigned to experimental and control groups using a draw container.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic's committee of semnan University of Medical Sciences
Street address
No.142,west erfan avenue,baharestan town,semnan,iran
City
semnan
Province
Semnan
Postal code
3514413436
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
ir.semums.rec.1396,170

Health conditions studied

1

Description of health condition studied
social anxiety disorder
ICD-10 code
F40.1
ICD-10 code description
Social phobias

Primary outcomes

1

Description
psycholoical symptoms of social anxiety disorder,
Timepoint
Measurement of physiological symptoms social anxiety disorder such as heart rate oscillation, skin temperature, respiratory distress, muscle tension at the beginning of the study and during treatment based on exposure virtual reality sessions and two months after the end of the intervention.
Method of measurement
physiological symptoms assesment device(CAPTIV)

2

Description
cognitive_behavioral symptoms of social anxiety disorder
Timepoint
Measurement of cognitive_behavioral symptoms of social anxiety disorder such as avoidance, fear of negative evaluation, social turmoil at the beginning of the study and during treatment based on exposure virtual reality sessions and two months after the end of the intervention.
Method of measurement
Conner social anxiety quesionnaire and Watson & Trend's Avoidance Social turmoil Scale

Secondary outcomes

empty

Intervention groups

1

Description
Patients with social anxiety disorder are subjected to virtual reality-based exposure therapy sessions, which consists of 12 sessions, which first comes from the patient's anxiety hierarchy, and according to virtual scenes designed with social anxiety content in each patient's session, The weakest hierarchy of content faces up to the harshest anxiety content of the hierarchy and During the sessions, the patient's physiological and cognitive-behavioral symptoms are recorded and measured.
Category
Treatment - Other

2

Description
Control group: patients with social anxiety disorder who do not receive any intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Semnan University
Full name of responsible person
Hoda Nazemi
Street address
No.142,west erfan avenue,baharestan town,semnan,iran
City
Semnan
Province
Semnan
Postal code
3514413436
Phone
+98 23 3349 0213
Email
hoda.nazemi@semnan.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan university
Full name of responsible person
Dr isaac rahimian bogar
Street address
Faculty of Psychology & Educational sciences Mahdishahr , Semnan University , Darband, Mehdishahr, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 3300
Fax
+98 23 3362 6888
Email
Hoda.nazemi@semnan.ac.ir
Web page address
http://psy.semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan university
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan university
Full name of responsible person
Hoda nazemi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
NO.142,west erfan avenu,baharestan town,semnan,iran
City
Ssemnan
Province
Semnan
Postal code
3514413436
Phone
+98 23 3349 0213
Email
Hoda.nazemi@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Psychology and Educational Sciences, Semnan University
Full name of responsible person
Dr mahmood najafi
Position
University faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology & Educational sciences Mahdishahr , Semnan University , Darband, Mehdishahr, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 3300
Fax
+98 23 3362 6888
Email
m_najafi@semnan.ac.ir
Web page address
http://psy.semnan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Psychology and Educational Sciences, Semnan University
Full name of responsible person
Hoda nazemi
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
NO.142.west erfan avenu,baharestan town,semnan,iran
City
semnan
Province
Semnan
Postal code
3514413436
Phone
+98 23 3349 0213
Fax
+98 23 3349 0213
Email
hoda.nazemi@semnan.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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