]>
IRCT20250715066505N1 IRCT 2025-09-01 Zanjan University of Medical Sciences The effectiveness of Emotion Regulation Therapy on reducing the severity of symptoms and certain emotional and cognitive components in individuals with Social Anxiety Disorder. The effectiveness of Emotion Regulation Therapy on reducing the severity of symptoms and certain emotional and cognitive components in individuals with Social Anxiety Disorder. 2025-09-06 anticipated 46 Complete https://irct.ir/trial/85408 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be performed using Microsoft Excel. To do this, in the first column, 20 number “1” entries and 20 number “2” entries (representing the experimental and control groups, respectively) will be entered. Then, in the second column, 40 random numbers will be generated using the RAND function. The data will be sorted based on the values in the random number column (either in ascending or descending order). Through this sorting, the sequence of 1s and 2s will also be rearranged randomly. According to the new order of 1s and 2s, the participants will be assigned to the two groups, Blinding description: In the implementation of this study, blinding will be done in such a way that the therapist and the evaluator are two different people, the therapist is the student, and the evaluator will be a clinical psychology graduate who will not know about the people of both groups in the process of evaluating the occurrence of consequences and reduction of symptoms before and after treatment and also during the follow-up period. N/A Social Anxiety Disorder. Intervention 1: Intervention group: Intervention group: This group will consist of 23 patients diagnosed with Social Anxiety Disorder who will receive Mennin’s Emotion Regulation Therapy (ERT) protocol twice weekly for a total of 16 sessions, each lasting 60–90 minutes. Assessments will be conducted at baseline, post-treatment, and three months after treatment completion. ERT is a third-wave, emotion-focused cognitive-behavioral therapy with a structured, stage-based format aimed at enhancing emotional awareness, developing regulation skills, and employing newly learned contextual strategies. Intervention 2: Control group: This group will include 23 patients with Social Anxiety Disorder who will receive no intervention during the study period and will be placed on a waitlist. After the study concludes, they will be offered Mennin’s Emotion Regulation Therapy (ERT) protocol, delivered twice weekly for 16 sessions of 60–90 minutes each. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Decision on sharing IPD data is pending the completion of ethical and legal review by the research ethics committee, and there is currently no defined plan for data release.
public Dr. Seyede Elnaz Mousavi
Department of Clinical Psychology, Dr. Beheshti Psychiatric Hospital, Ark Square
Zanjan Iran (Islamic Republic of) 4513615788 +98 24 3354 4001 elnaz48.mousavi@gmail.com Zanjan University of Medical Sciences scientific Dr. Seyede Elnaz Mousavi
Department of Clinical Psychology, Dr. Beheshti Psychiatric Hospital, Ark Square
Zanjan Iran (Islamic Republic of) 4513615788 +98 24 3354 4001 elnaz48.mousavi@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Presence of symptoms consistent with Social Anxiety Disorder as determined by the Structured Clinical Interview for DSM-IV Axis I and II Disorders (SCID-I and SCID-II), and a minimum score of 55 on the Liebowitz Social Anxiety Scale (LSAS) Possession of a high school diploma or higher level of formal education Age range between 18 and 60 years Willingness of participants to take part in the study as indicated by the provisions of the written informed consent 18 years 60 years Both Diagnosis of depressive disorders, bipolar disorder, psychotic spectrum disorders, autism spectrum disorders, or personality disorders Previous participation in formal emotion regulation clinical trials for Social Anxiety Disorder (SAD) Current psychiatric medication use Substance or alcohol use within the past three months F40.1 Social phobias Treatment - Other Treatment - Other Intervention group: Intervention group: This group will consist of 23 patients diagnosed with Social Anxiety Disorder who will receive Mennin’s Emotion Regulation Therapy (ERT) protocol twice weekly for a total of 16 sessions, each lasting 60–90 minutes. Assessments will be conducted at baseline, post-treatment, and three months after treatment completion. ERT is a third-wave, emotion-focused cognitive-behavioral therapy with a structured, stage-based format aimed at enhancing emotional awareness, developing regulation skills, and employing newly learned contextual strategies. Control group: This group will include 23 patients with Social Anxiety Disorder who will receive no intervention during the study period and will be placed on a waitlist. After the study concludes, they will be offered Mennin’s Emotion Regulation Therapy (ERT) protocol, delivered twice weekly for 16 sessions of 60–90 minutes each. Severity of Social Anxiety Disorder symptoms. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Liebowitz Social Anxiety Scale. Negative Mood Regulation Expectancies. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Negative Mood Regulation Expectancies Questionnaire (NMRE). Emotion dysregulation. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Difficulties In Emotion Regulation Scale (DERS). Post Event Processing. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Post Event Processing Questionnaire (PEPQ). Zanjan University of Medical Sciences Approved 2025-05-26 Ethics committee of Zanjan University of Medical Sciences 1st Floor, Building No. 1, Zanjan University of Medical Sciences and Health Services, Beginning of Jomhouri Eslami Street, Azadi Square Zanjan Zanjan Iran (Islamic Republic of)