Efficacy of cognitive behavioral therapy (CBT) and virtual reality exposure therapy (VRET) on fear of negative evaluation and social anxiety disorder symptoms among adolescents
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Protocol summary
A clinical trial with a control group, parallel groups, not blinded and nonrandomized, on 102 patients.
A clinical trial with a control group, parallel groups, blinded and nonrandomized, on 51 patients.
A clinical trial with a control group, parallel groups, not blinded and nonrandomized, on 10251 patients.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، کور نشده، تصادفی نشده، بر روی 102 بیمار.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، کور شده، تصادفی نشده، بر روی 51 بیمار.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، کور نشدهشده، تصادفی نشده، بر روی 10251 بیمار.
General information
102
51
10251
The addition of 17 people in each study group and the addition of information related to randomization and blinding
I noticed that when registering the virtual reality group sessions, I wrote 8 sessions, while both treatments were 12 sessions. Also, the information related to randomization and blinding was updated more accurately and the sample size was updated to the previous state. Also, in the intervention section 3, I made mistakes in entering the information of the control group, which was due to copying, and I deleted the extra information
The addition of 17 people in each studyI noticed that when registering the virtual reality group andsessions, I wrote 8 sessions, while both treatments were 12 sessions. Also, the addition of information related to randomization and blinding was updated more accurately and the sample size was updated to the previous state. Also, in the intervention section 3, I made mistakes in entering the information of the control group, which was due to copying, and I deleted the extra information
افزوده شدن ۱۷ نفر در هر گروه مورد مطالعه و افزوده شدن اطلاعات مربوط به تصادفی سازی و کورسازی
متوجه شدم که در زمان ثبت جلسات گروه درمان واقعیت مجازی را 8 نوشته ام در حالی که هر دو درمان 12 جلسه ای بوده اند. همچنین اطلاعات مربوط به تصادفی سازی و کورسازی به طور دقیقتری آپدیت شد و حجم نمونه به حالت قبل آپدیت شد. همچنین در بخش مداخله ۳ در وارد کردن اطلاعات گروه کنترل اشتباهاتی داشتم که به خاطر کپی کردن بود و اطلاعات اضافی را حذف کردم.
افزوده شدن ۱۷ نفرمتوجه شدم که در هرزمان ثبت جلسات گروه مورد مطالعه و افزوده شدندرمان واقعیت مجازی را 8 نوشته ام در حالی که هر دو درمان 12 جلسه ای بوده اند. همچنین اطلاعات مربوط به تصادفی سازی و کورسازی به طور دقیقتری آپدیت شد و حجم نمونه به حالت قبل آپدیت شد. همچنین در بخش مداخله ۳ در وارد کردن اطلاعات گروه کنترل اشتباهاتی داشتم که به خاطر کپی کردن بود و اطلاعات اضافی را حذف کردم.
All patients who consent to participate and fulfill the inclusion criteria are randomized using a random number table. In the table, a special code was assigned to each patient. To randomly assign each patient to the groups, the researcher randomly selected individuals from a table point in a row or direction: VRE (n=34), CBT therapy (n=34), and the waiting list control condition (n=34).
The participants were assigned to different groups based on a randomized, balanced block method using a random number table: VRE + CBT (n = 17), CBT (n = 17), and WLCC (n = 17). The randomization method was simple and the randomization unit was individual. Using Excel software, the consultant epidemiologist designed and drew a table of four balanced blocks.
All patients who consentThe participants were assigned to participate and fulfill the inclusion criteria aredifferent groups based on a randomized, balanced block method using a random number table: VRE + CBT (n = 17), CBT (n = 17), and WLCC (n = 17). InThe randomization method was simple and the table, a special coderandomization unit was assigned to each patientindividual. To randomly assign each patient to the groupsUsing Excel software, the researcher randomly selected individuals fromconsultant epidemiologist designed and drew a table point in a row or direction: VRE (n=34), CBT therapy (n=34), and the waiting list control condition (n=34)of four balanced blocks.
تمام بیمارانی که رضایت به شرکت در پژوهش داده اند و معیارهای ورود را برآورده کرده اند با استفاده از یک جدول اعداد تصادفی در گروه های مورد مطالعه گماشته میشوند. در جدول اعداد تصادفی، به ترتيب به هر یک از بیماران یک کُد مخصوص اختصاص دارد. محقق براى گمارش تصادفی هر یک از بیماران در گروه ها، بطور اتفاقى از يک نقطهٔ جدول در جهت سطر يا شروع به انتخاب افراد میکند: VRE (34 نفر) ، CBT درمانی (34 نفر) و وضعیت کنترل لیست انتظار (34 نفر)
شرکت کنندگان بر اساس یک روش بلوک تصادفی و متعادل با استفاده از جدول اعداد تصادفی به گروه های مختلف تقسیم شدند: VRE + CBT (n = 17)، CBT (n = 17)، و WLCC (n = 17). روش تصادفی سازی ساده و واحد تصادفی سازی فردی بود. مشاور اپیدمیولوژیست با استفاده از نرم افزار اکسل، جدول چهار بلوک متعادل را طراحی و ترسیم کرد.
تمام بیمارانی که رضایت به شرکت در پژوهش داده اندکنندگان بر اساس یک روش بلوک تصادفی و معیارهای ورود را برآورده کرده اندمتعادل با استفاده از یک جدول اعداد تصادفی دربه گروه های مورد مطالعه گماشته میشوند. در جدول اعداد تصادفی، به ترتيب به هر یک از بیماران یک کُد مخصوص اختصاص دارد. محقق براى گمارش تصادفی هر یک از بیماران در گروه ها، بطور اتفاقى از يک نقطهٔ جدول در جهت سطر يا شروع به انتخاب افراد میکندمختلف تقسیم شدند: VRE + CBT (34 نفرn = 17)، CBT درمانی (34 نفرn = 17)، و وضعیت کنترل لیست انتظارWLCC (34 نفرn = 17). روش تصادفی سازی ساده و واحد تصادفی سازی فردی بود. مشاور اپیدمیولوژیست با استفاده از نرم افزار اکسل، جدول چهار بلوک متعادل را طراحی و ترسیم کرد.
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.
Neither the therapist nor participants were blinded. However, data analysts and outcome assessors were blinded to the participants’ group assignments.
This study is a single-blind study in thatNeither the researchertherapist nor participants were blinded. However, data analysts and participants are aware of the allocating intervention, but the data analyst and the person conducting the assessments are blindoutcome assessors were blinded to the specific participantparticipants’s group assignments.
این مطالعه یک مطالعه کور است به این دلیل که محقق و شرکت کنندگان از مداخله تخصیص یافته آگاهند ، اما تحلیلگر داده و شخصی که ارزیابی ها را انجام می دهد نسبت به گروه شرکت کننده خاص کور بودند.
نه درمانگر و نه شرکت کنندگان کور نشدند. با این حال، تحلیلگران داده و ارزیابهای نتیجه نسبت به تکالیف گروهی شرکتکنندگان کور بودند.
این مطالعه یک مطالعه کور است به این دلیل که محققنه درمانگر و نه شرکت کنندگان از مداخله تخصیص یافته آگاهند کور نشدند. با این حال، اما تحلیلگرتحلیلگران داده و شخصی که ارزیابی ها را انجام می دهدارزیابهای نتیجه نسبت به گروهتکالیف گروهی شرکت کننده خاصکنندگان کور بودند.
Intervention groups
#1
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.
Control group: One week after entering the study, the patients in this group will be tested on the symptoms of social anxiety disorder, and fear of negative evaluation 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 and fear of negative evaluation will be measured again.
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,and 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, and fear of negative evaluation, anxiety sensitivity, and quality of life will be measured again.
گروه کنترل: بیماران در این گروه یک هفته پس از ورود به مطالعه، به وسیله پرسشنامه ها تحت سنجش میزان علائم اختلال اضطراب اجتماعی، تنظیم شناختی هیجان، ترس از ارزیابی منفی، حساسیت اضطرابی و کیفیت زندگی قرار خواهند گرفت. همچنین یک هفته پس از اتمام آخرین جلسه درمانی شرکت کنندگان در گروه های درمان شناختی رفتاری و درمان مواجهه از طریق واقعیت مجازی، مجددا علائم اختلال اضطراب اجتماعی، تنظیم شناختی هیجان، ترس از ارزیابی منفی، حساسیت اضطرابی و کیفیت زندگی در آن ها اندازه گیری خواهد شد.
گروه کنترل: بیماران در این گروه یک هفته پس از ورود به مطالعه، به وسیله پرسشنامه ها تحت سنجش میزان علائم اختلال اضطراب اجتماعی و ترس از ارزیابی منفی قرار خواهند گرفت. همچنین یک هفته پس از اتمام آخرین جلسه درمانی شرکت کنندگان در گروه های درمان شناختی رفتاری و درمان مواجهه از طریق واقعیت مجازی، مجددا علائم اختلال اضطراب اجتماعی و ترس از ارزیابی منفی در آن ها اندازه گیری خواهد شد.
گروه کنترل: بیماران در این گروه یک هفته پس از ورود به مطالعه، به وسیله پرسشنامه ها تحت سنجش میزان علائم اختلال اضطراب اجتماعی، تنظیم شناختی هیجان، و ترس از ارزیابی منفی، حساسیت اضطرابی و کیفیت زندگی قرار خواهند گرفت. همچنین یک هفته پس از اتمام آخرین جلسه درمانی شرکت کنندگان در گروه های درمان شناختی رفتاری و درمان مواجهه از طریق واقعیت مجازی، مجددا علائم اختلال اضطراب اجتماعی، تنظیم شناختی هیجان، و ترس از ارزیابی منفی، حساسیت اضطرابی و کیفیت زندگی در آن ها اندازه گیری خواهد شد.
Protocol summary
Study aim
Efficacy of cognitive behavioral therapy with virtual reality exposure therapy on the social anxiety disorder symptoms and fear of negative evaluation in adolescents
Design
A clinical trial with a control group, parallel groups, blinded and nonrandomized, on 51 patients.
Settings and conduct
If eligible, patients with a social anxiety disorder referred to the Atieh Clinic in Bushehr City will be included in the study and assigned to experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion: 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; Do not receive other current psychological treatment; Age between 14 - 18.
Exclusion: Having hearing or visual impairment such as stereoscopy blindness or nystagmus; 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; Receiving other psychological treatment.
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
Social anxiety disorder symptoms and Fear of negative evaluation
General information
Reason for update
I noticed that when registering the virtual reality group sessions, I wrote 8 sessions, while both treatments were 12 sessions. Also, the information related to randomization and blinding was updated more accurately and the sample size was updated to the previous state. Also, in the intervention section 3, I made mistakes in entering the information of the control group, which was due to copying, and I deleted the extra information
Acronym
CBT, VRET
IRCT registration information
IRCT registration number:IRCT20210213050343N2
Registration date:2023-09-18, 1402/06/27
Registration timing:prospective
Last update:2024-11-16, 1403/08/26
Update count:2
Registration date
2023-09-18, 1402/06/27
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
2023-09-22, 1402/06/31
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of cognitive behavioral therapy (CBT) and virtual reality exposure therapy (VRET) on fear of negative evaluation and social anxiety disorder symptoms among adolescents
Public title
Efficacy of cognitive behavioral therapy (CBT) and virtual reality exposure therapy (VRET) on social anxiety disorder symptoms
Purpose
Education/Guidance
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 hearing or visual impairment such as stereoscopy blindness or nystagmus.
Presence of specific physiological illnesses such as heart, lung, and respiratory diseases, epilepsy and seizures, developmental or intellectual disability, cognitive impairment, and known balance disorders such as vertigo.
Receiving other psychological treatment.
Age
From 14 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were assigned to different groups based on a randomized, balanced block method using a random number table: VRE + CBT (n = 17), CBT (n = 17), and WLCC (n = 17). The randomization method was simple and the randomization unit was individual. Using Excel software, the consultant epidemiologist designed and drew a table of four balanced blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Neither the therapist nor participants were blinded. However, data analysts and outcome assessors were blinded to the participants’ group assignments.
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 University of Medical Sciences ,Moalem St., Bushehr.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2023-08-25, 1402/06/03
Ethics committee reference number
IR.BPUMS.REC.1402.124
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
Fear of negative evaluation
Timepoint
One week before the intervention, one week after the last intervention session, and three months after the last intervention session.
Method of measurement
Brief Fear of Negative Evaluation Scale (FNES-B)
2
Description
Social anxiety disorder symptoms
Timepoint
One week before the intervention, one week after the last intervention session, and three months after the last intervention session.
Method of measurement
The Social Phobia Inventory (SPIN)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Cognitive-behavioral therapy: cognitive-behavioral therapy sessions will be held 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 problem conceptualization. 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 maintaining 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 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 be held according to its standard protocol for social anxiety disorder (including eight 60-minute sessions twice weekly). 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 safely. 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, and fear of negative evaluation 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 and fear of negative evaluation will be measured again.
Persian Gulf Street, Persian Gulf University, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2710
Email
parisa0730@gmail.com
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
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
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 Gulf Street, Persian Gulf University, Bushehr, Iran.
City
Boushehr
Province
Boushehr
Postal code
۷۵۱۶۹۱۳۸۱۷
Phone
+98 77 3122 2078
Fax
Email
parisa0730@gmail.com
Person responsible for scientific inquiries
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 Gulf Street, Persian Gulf University, Bushehr, Iran.
City
Boushehr
Province
Boushehr
Postal code
۷۵۱۶۹۱۳۸۱۷
Phone
+98 77 3122 2078
Fax
Email
parisa0730@gmail.com
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 Gulf Street, Persian Gulf University, Bushehr, Iran.
City
Boushehr
Province
Boushehr
Postal code
۷۵۱۶۹۱۳۸۱۷
Phone
+98 77 3122 2078
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 social anxiety disorder symptoms, and fear of negative evaluation questionnaires in the pre-test, post-test, and follow-up will be analyzed 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
Parisa Azimisefat, Department of Psychology, Persian Gulf University, Bushehr, Iran. parisa0730@gmail.com 0098184025128
What processes are involved for a request to access data/document
The applicant provides information about their application via email. If accepted, documents or data files will be sent up to two weeks after the request.