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Comparison of the Effectiveness of Cognitive - Behavioral Therapy (CBT) with Virtual Reality Exposure Therapy (VRET) on Cognitive Emotion Regulation, Fear of Negative Evaluation, Anxiety Sensitivity, and Quality of Life in Adolescents with Symptoms of Social Anxiety Disorder

Protocol summary

Study aim
To compare the effectiveness of cognitive behavioral therapy with virtual reality exposure therapy on cognitive emotion regulation, fear of negative evaluation, anxiety sensitivity, and quality of life in adolescents with social anxiety disorder.
Design
A clinical trial with a control group, parallel groups, not blinded and nonrandomized, on 51 patients.
Settings and conduct
If eligible, patients with a social anxiety disorder who refer to the Hadaf Bartar Clinic in Qaemshahr city will be included in the study and assigned to experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A Social Phobia Inventory score greater than or equal to 40, Fulfilling all diagnostic criteria of social phobia based on the Structured Clinical Interview for DSM-5, Providing written informed consent for participation in the study by participants and their parents, No presence of any other mental disorders, No history of mental illness, No dependence on alcohol or drugs, Do not receive other current psychological treatment, Age between 14 - 18. Exclusion criteria: Having suicidal thoughts and beliefs.
Intervention groups
Intervention group 1: cognitive-behavioral therapy: includes twelve 60-minute sessions twice per week of cognitive-behavioral therapy according to the standard protocol of Clark and Wells. Intervention group 2: virtual reality exposure therapy: includes eight 60-minute sessions twice per week of virtual reality therapy according to the standard protocol of exposure therapy for specific phobias. Control group: Participants will be evaluated one week before the intervention, one week after, and three months after the last intervention session.
Main outcome variables
Cognitive Emotion Regulation; Fear of negative evaluation; Anxiety sensitivity; Quality of Life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220905055887N1
Registration date: 2022-11-18, 1401/08/27
Registration timing: retrospective

Last update: 2022-11-18, 1401/08/27
Update count: 0
Registration date
2022-11-18, 1401/08/27
Registrant information
Name
Nazila Razaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4225 4028
Email address
naazila.razzaghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Cognitive - Behavioral Therapy (CBT) with Virtual Reality Exposure Therapy (VRET) on Cognitive Emotion Regulation, Fear of Negative Evaluation, Anxiety Sensitivity, and Quality of Life in Adolescents with Symptoms of Social Anxiety Disorder
Public title
Comparison of the Effectiveness of Cognitive - Behavioral Therapy (CBT) with Virtual Reality Exposure Therapy (VRET) on Social Anxiety Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A Social Phobia Inventory (SPIN) score greater than or equal to 40 Fulfilling all diagnostic criteria of social phobia based on the Structured Clinical Interview for DSM-5 (SCID-5) Providing written informed consent for participation in the study by participants and their parents No presence of any other mental disorders No history of mental illness No dependence on alcohol or drugs Do not receive other current psychological treatment Age between 14 - 18
Exclusion criteria:
Having suicidal thoughts and beliefs
Age
From 14 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee of Islamic Azad University - Boroujerd Branch
Street address
Imam Khomeini University Complex, 3 km of Yadegar Imam Road, Navab Square, Boroujerd, Iran.
City
Boroujerd
Province
Lorestan
Postal code
6915136335
Approval date
2022-08-13, 1401/05/22
Ethics committee reference number
IR.IAU.B.REC.1401.017

Health conditions studied

1

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

Primary outcomes

1

Description
Cognitive Emotion Regulation
Timepoint
One week before the intervention, one week after the last intervention session, three month after the last intervention session.
Method of measurement
Cognitive Emotion Regulation Questionnaire (CERQ)

2

Description
Fear of negative evaluation
Timepoint
One week before the intervention, one week after the last intervention session, three month after the last intervention session.
Method of measurement
Brief Fear of Negative Evaluation Scale (FNES-B)

3

Description
Anxiety sensitivity
Timepoint
One week before the intervention, one week after the last intervention session, three month after the last intervention session.
Method of measurement
Anxiety Sensitivity Index (ASI-R)

4

Description
Quality of Life
Timepoint
One week before the intervention, one week after the last intervention session, three month after the last intervention session.
Method of measurement
Quality of Life questionnaire (QOL-BREF)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Cognitive-behavioral therapy: cognitive-behavioral therapy sessions will hold according to its standard protocol for social anxiety disorder (including twelve 60-minute sessions twice per week). This therapy is based on the Clark and Wells model, which emphasizes self-focused attention because social anxiety disorder is associated with reduced processing of social cues (Tsitsas & Paschali, 2014). The content of cognitive behavioral therapy sessions is described below: Session 1 aims to evaluate and conceptualize the problem and create a therapeutic alliance. In Session 2, the focus is on psycho-education, goal setting, and conceptualization of the problem. Participants are primarily informed about the general structure of the sessions and agenda setting. Then, the objectives that the participants want to achieve at the end of the process are determined. In Session 3, the focus is on how the participants’ automatic thoughts, cognitive distortions, and safety behaviors relate to their problem and their effect on the maintenance of this issue. In Session 4, a specific memory of early negative life experiences related to the participants’ problem, the meaning they ascribe to this memory, and images are identified and reevaluated using the empty chair technique. In Sessions 5, 6, and 7, the participants' beliefs about their problems will be determined based on the agenda, and cognitive interventions will be carried out for the determined beliefs. During these interventions, what the participants will learn in the fourth session is also utilized. In Session 8, the avoidance and safety behaviors of the participants are discussed, and the rationality of exposure and habituation, its place, and its importance in coping with the problem is evaluated. In Sessions 9, 10, and 11, cognitive and behavioral interventions are carried out simultaneously. Cognitive and behavioral techniques are used together to intervene on the agenda items determined together with the participants. In these sessions, participants are exposed to these situations they avoid that are related to their problems during the session and daily life. In Session 12, the process will end.
Category
Behavior

2

Description
Intervention group 2: Virtual reality exposure therapy: Virtual reality exposure therapy sessions will hold according to its standard protocol for social anxiety disorder (including eight 60-minute sessions twice per week). We will conduct virtual reality therapy sessions with a Desktop Computer with the specifications; Graphics Card: ASUS NVIDIA GEFORCE GTX 1060 6GB GDDR5, CPU: Core i7-4,790 (8 M Cache, up to 4.00 GHz), RAM: 8 GB DDR4, and an Oculus Rift Dk2 Virtual Reality Headset. These tools enable us to create a virtual environment and provide virtual reality stimuli to the patient in a safe manner. We will use the Unity platform for creating virtual reality experiences and scenarios. Patients will move within the virtual environment with a virtual reality gamepad. The therapist will explain how to use the app and conduct therapeutic sessions by following the standard protocols of cognitive behavioral therapy for specific phobias (Scozzari and Gamberini, 2011). Four different virtual reality scenarios are offered. Patients are confronted with one virtual reality scenario in each session. Depending on how fast the user wanted to pass the scenarios, each session took an average of 60 min to complete. In the final session, all virtual reality scenarios were presented one after another. The therapist will provide the content of cognitive-behavioral therapy using the six modules below: Module 1: The therapist will describe social phobic anxiety and provide information about the possibility of retaining safety. At the same time, in social phobic situations, educate the patient about how social phobic anxiety develops in a virtual reality environment and explain how the patient can overcome it. Module 2: The therapist will inform and educate the patient about the fear curve and how to set realistic goals to overcome his or her social phobic fears. Module 3: Immersion will take between twenty minutes. As exposure to virtual reality scenarios may provoke anticipatory fear, the therapist will explain to the patient that this is a normal response and that exposure to a virtual environment is not, in fact, dangerous. Module 4: The therapist will explain how automatic, catastrophic thoughts affect a patient’s fear and anxiety. Also, the patient is encouraged to reflect on how realistic her catastrophic thoughts are .Module 5: The therapist will invite the patient to think about his or her unrealistic thoughts about the fear, explain why these thoughts are unrealistic, and help the patient formulate more realistic thoughts. Module 6: The therapist will encourage the patient to apply the new knowledge so that she can start practicing exposure to social situations in the real world.
Category
Behavior

3

Description
Control group: One week after entering the study, the patients in this group will be tested on the symptoms of social anxiety disorder, cognitive regulation of emotion, fear of negative evaluation, anxiety sensitivity, and quality of life through questionnaires. Also, one week after the last treatment session of participants in cognitive behavioral therapy group and virtual reality therapy, symptoms of social anxiety disorder, cognitive regulation of emotion, fear of negative evaluation, anxiety sensitivity, and quality of life will be measured again.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hadaf Bartar Clinic
Full name of responsible person
Zeynab Valian
Street address
Babol St., in front of Amirkabir Alley, Qaemshar
City
Qaemshar
Province
Mazandaran
Postal code
6515784638
Phone
+98 11 4224 4724
Email
z.valian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Dinarvand
Street address
Imam Khomeini University Complex, 3 km of Yadegar Imam Road, Navab Square, Boroujerd, Iran.
City
Boroujerd
Province
Lorestan
Postal code
6915136335
Phone
+98 66 4251 8023
Email
Ali_dinarvand6164@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Nazila Razaghi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Imam Khomeini University Complex, 3 km of Yadegar Imam Road, Navab Square, Boroujerd, Iran.
City
Boroujerd
Province
Lorestan
Postal code
4765815615
Phone
+98 11 4225 4028
Email
naazil.razzaghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Davood Jafari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Imam Khomeini University Complex, 3 km of Yadegar Imam Road, Navab Square, Boroujerd, Iran.
City
Boriujerd
Province
Lorestan
Postal code
6915136335
Phone
+98 66 4251 8000
Email
davood_jafari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nazila Razaghi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Imam Khomeini University Complex, 3 km of Yadegar Imam Road, Navab Square, Boroujerd, Iran.
City
Boroujerd
Province
Lorestan
Postal code
4765815615
Phone
+98 11 4225 4028
Email
naazil.razzaghi@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 cognitive emotion regulation, anxiety sensitivity, fear of negative evaluation, quality of life, and social anxiety disorder questionnaires in the pre-test, post-test, and follow-up will analyze using SPSS software. The results (without mentioning the names of the participants) will be shared.
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
Nazila Razaghi, Department of Psychology, Islamic Azad University, Boroujerd Branch, Iran. naazil.razzaghi@gmail.com 00989333917995
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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