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IRCT20210613051562N1 IRCT 2022-10-04 Counseling Center of Guilan University The efficacy of an Internet-based intervention on reducing social anxiety The efficacy of an Internet-based attention modification intervention on reducing social anxiety in student with social anxiety disorder: a clinical trial 2022-10-23 anticipated 60 Complete https://irct.ir/trial/65773 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible people will be divided into intervention and control groups using the block randomization method with the size of blocks of 4 and 6. To generate randomization list, online randomization service of Sealed Envelope Ltd. 2019 will be used (https://www.sealedenvelope.com/simple-randomiser/v(۱/lists). Concealment is done through sealed opaque envelopes in a random sequence. Preparing these envelopes and determining the sequence of random allocation is done by a researcher who has no knowledge or connection with the participants. In the first in-person meeting with each participant, the researcher, who did not participate in determining the sequence of random allocation and does not know the type of participant's group, provides the participant with the previously prepared envelope. In this way, the researcher evaluating the outcome variables as well as the participants will be unaware of the group type, Blinding description: Participants will be unaware of their group type. Also, a researcher who divides the participants into two study groups, implements the measurement tools before starting the treatment (pre-test) and re-implements the same tools after the treatment is completed (post-test), will not know the type of the participants' group. In the explanation of the research, the participants will be told that "the present study is to be conducted in order to investigate the efficacy of a computer-based treatment for social anxiety and they will be randomly assigned to one of the two study groups, and depending on their group, they will complete one of the two computer-based programs; one of these programs is designed to treat social anxiety, but the other program is not designed to reduce social anxiety and may have a placebo effect.". N/A Social Anxiety Disorder (social phobia). Intervention 1: Intervention group:The intervention group consists of students diagnosed with social anxiety disorder, and the "Attention Bias Modification Program" will be implemented on them as a therapeutic intervention. To implement the Attention Bias Modification Program intervention, the probe detection task will be used, which is a modified form of the task used to measure attention bias. In this computer intervention, during 160 trials, neutral and negative face images appear equally in random order in the upper and lower parts of the screen, and then the probe mark appears in the place where the neutral image was located. Repeating this procedure enables the participant to realize that the neutral images are predictive of the location of the probe. The rationale behind Attention Bias Modification Program is that, although participants are not told to shift their attention away from the negative and threatening image, the location of the neutral image represents the probe location on all trials, thereby facilitating participants' attention to the non-threatening stimuli. Intervention 2: Control group:The control group consists of students diagnosed with social anxiety disorder, and the only difference between them and the intervention group is the implementation of an intervention, which according to the research literature is not effective and acts as a placebo. The task of this group (Attention Control Condition) is similar to the task used in the intervention group, except that during the presentation of trials, only one neutral image appear, instead of two negative and neutral images in task of intervention group. Therefore, because negative and neutral facial images are not used simultaneously, participants will not learn to pay attention to neutral in the presence of negative stimuli. No - There is not a plan to make this available Justification or reason for not sharing IPD is At the moment, we have not decided to share the data, however, if there is a request from the researchers, it will be made available.
public Hassan Farrahi
Education unit, Shafa hospital, 15th khordad
Rasht Iran (Islamic Republic of) 4193955599 +98 13 3366 6268 h.farrahi14@gmail.com Guilan University of Medical Sciences scientific Hassan Farrahi
Education unit, Shafa hospital, street 15th khordad
Rasht Iran (Islamic Republic of) 4193955599 +98 13 3366 6268 h.farrahi14@gmail.com Guilan University of Medical Sciences Iran (Islamic Republic of) The ability to read fluently in Persian Access to a computer and internet connection Having social anxiety higher than 30 on the Liebowitz Social Anxiety Scale 18 years 30 years Both Having current or previous schizophrenia, schizoaffective, or bipolar disorders Having diseases that would negatively affect participation in the current study, such as epilepsy or brain damage History of stroke or neurodegenerative diseases Substance abuse and dependence in the last 6 months Current cognitive impairment Suicidal intention in the last 3 months Visual impairment affecting participation in research Receiving psychological treatment currently or in the past 6 months Receiving medication-based treatment leading to recovery now or in the last 3 months F40.10 Social phobia, unspecified Treatment - Other Placebo Intervention group:The intervention group consists of students diagnosed with social anxiety disorder, and the "Attention Bias Modification Program" will be implemented on them as a therapeutic intervention. To implement the Attention Bias Modification Program intervention, the probe detection task will be used, which is a modified form of the task used to measure attention bias. In this computer intervention, during 160 trials, neutral and negative face images appear equally in random order in the upper and lower parts of the screen, and then the probe mark appears in the place where the neutral image was located. Repeating this procedure enables the participant to realize that the neutral images are predictive of the location of the probe. The rationale behind Attention Bias Modification Program is that, although participants are not told to shift their attention away from the negative and threatening image, the location of the neutral image represents the probe location on all trials, thereby facilitating participants' attention to the non-threatening stimuli. Control group:The control group consists of students diagnosed with social anxiety disorder, and the only difference between them and the intervention group is the implementation of an intervention, which according to the research literature is not effective and acts as a placebo. The task of this group (Attention Control Condition) is similar to the task used in the intervention group, except that during the presentation of trials, only one neutral image appear, instead of two negative and neutral images in task of intervention group. Therefore, because negative and neutral facial images are not used simultaneously, participants will not learn to pay attention to neutral in the presence of negative stimuli. Attention bias. Timepoint: Before intervention, after intervention, and 2 month after intervention. Method of measurement: Dot probe task. Social anxiety. Timepoint: Before intervention, after intervention, and 2 month after intervention. Method of measurement: Liebowitz Social Anxiety Scale. Trait anxiety. Timepoint: Before intervention, after intervention, and 2 month after intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory. Depression. Timepoint: Before intervention, after intervention, and 2 month after intervention. Method of measurement: Patient Health Questionnaire-9. Counseling Center of Guilan University Approved 2022-06-29 Research Ethics Committees of Guilan university of medical sciences Education unit, Shafa hospital, 15 Khordad street Rasht Guilan Iran (Islamic Republic of)