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IRCT20220905055887N1 IRCT 2022-11-18 Islamic Azad University Comparison of the Effectiveness of Cognitive - Behavioral Therapy (CBT) with Virtual Reality Exposure Therapy (VRET) on Social Anxiety Disorder 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 2022-09-22 anticipated 51 Complete https://irct.ir/trial/65715 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Social phobias. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: 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 access period starts 6 months after the results are published. To whom: The data of this study will be available only to researchers working in academic and scientific institutions. Conditions: The data of this study will be provided for use by researchers in review or comparative studies. Where to obtain: Nazila Razaghi, Department of Psychology, Islamic Azad University, Boroujerd Branch, Iran. naazil.razzaghi@gmail.com 00989333917995 How to obtain: 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. Comments:
public Nazila Razaghi
Imam Khomeini University Complex, 3 km of Yadegar Imam Road, Navab Square, Boroujerd, Iran.
Boroujerd Iran (Islamic Republic of) 4765815615 +98 11 4225 4028 naazil.razzaghi@gmail.com Islamic Azad University scientific Davood Jafari
Imam Khomeini University Complex, 3 km of Yadegar Imam Road, Navab Square, Boroujerd, Iran.
Boriujerd Iran (Islamic Republic of) 6915136335 +98 66 4251 8000 davood_jafari@yahoo.com Islamic Azad University Iran (Islamic Republic of) 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 14 years 18 years Both Having suicidal thoughts and beliefs F40.1 Social phobias Behavior Behavior Behavior 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. 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. 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. 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). 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). 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). 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). Islamic Azad University Approved 2022-08-13 Research Ethics Committee of Islamic Azad University - Boroujerd Branch Imam Khomeini University Complex, 3 km of Yadegar Imam Road, Navab Square, Boroujerd, Iran. Boroujerd Lorestan Iran (Islamic Republic of)