Protocol summary
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Study aim
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Efficacy of cognitive behavioral therapy with virtual reality exposure therapy on the social anxiety disorder symptoms and fear of negative evaluation in adolescents
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Design
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A clinical trial with a control group, parallel groups, blinded and nonrandomized, on 51 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Social anxiety disorder symptoms and Fear of negative evaluation
General information
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Reason for update
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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
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Acronym
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CBT, VRET
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IRCT registration information
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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
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Registration date
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2023-09-18, 1402/06/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-09-22, 1402/06/31
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Expected recruitment end date
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2023-10-22, 1402/07/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Efficacy of cognitive behavioral therapy (CBT) and virtual reality exposure therapy (VRET) on social anxiety disorder symptoms
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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.
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Age
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From 14 years old to 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
51
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Neither the therapist nor participants were blinded. However, data analysts and outcome assessors were blinded to the participants’ group assignments.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-08-25, 1402/06/03
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Ethics committee reference number
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IR.BPUMS.REC.1402.124
Health conditions studied
1
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Description of health condition studied
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Social anxiety disorder
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ICD-10 code
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F40.1
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ICD-10 code description
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Social phobias
Primary outcomes
1
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Description
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Fear of negative evaluation
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Timepoint
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One week before the intervention, one week after the last intervention session, and three months after the last intervention session.
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Method of measurement
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Brief Fear of Negative Evaluation Scale (FNES-B)
2
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Description
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Social anxiety disorder symptoms
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Timepoint
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One week before the intervention, one week after the last intervention session, and three months after the last intervention session.
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Method of measurement
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The Social Phobia Inventory (SPIN)
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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Behavior
3
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Description
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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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Persian Gulf University
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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The access period starts 6 months after the results are published.
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To whom data/document is available
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The data of this study will be available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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The data of this study will be provided for use by researchers in review or comparative studies.
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From where data/document is obtainable
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Parisa Azimisefat, Department of Psychology, Persian Gulf University, Bushehr, Iran. parisa0730@gmail.com 0098184025128
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What processes are involved for a request to access data/document
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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.
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Comments
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