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IRCT20250629066298N1 IRCT 2025-08-02 Islamic Azad University Studying the effect of compassion-based therapy on improving mindfulness and social confidence in female students with social anxiety A randomized clinical trial to evaluate the effectiveness of compassion-focused therapy on mindfulness skills and social self-efficacy in female students with social anxiety disorder 2025-08-20 anticipated 30 Complete https://irct.ir/trial/85049 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting one educational district and one school from Ahvaz,30 female students who met the inclusion criteria and had been diagnosed with social anxiety disorder through counseling centers were recruited.Following screening,each participant was assigned a numerical code.Then,using a random number table,the participants were randomly allocated into two groups:intervention (n=15) and control (n=15). 2 Social Anxiety Disorder. Intervention 1: Intervention group: Consisted of 15 female students with social anxiety disorder who received compassion-focused therapy over 8 weekly sessions. Intervention 2: Control group: Consisted of 15 female students without receiving any intervention. Yes - There is a plan to make this available What will be shared: Anonymized Data Sharing Plan for Qualified Researchers When: De-identified data will be available starting 6 months after study completion and will remain accessible for 3 years To whom: Qualified researchers who submit a formal request and obtain approval from the ethics committee will be allowed to access the de-identified data. Access will be granted solely for scientific and research purposes. Conditions: The data may only be used for scientific and research purposes. Access requires a formal request, ethics committee approval, and a written commitment to maintain participant confidentiality. Commercial use of the data is not permitted. Where to obtain: fati.tizvir75@gmail.com please send email. How to obtain: The applicant must submit a formal request via email to the Principal Investigator at fati.tizvi75@gmail.com. After identity verification and signing a confidentiality agreement (if required), the data will be provided within 7 to 15 working days. Comments:
public Fatemeh tizvir
No. 67, Khalij Fars 3 Street, End of Aria Boulevard, Baharestan, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 6137785418 +98 61 3372 2238 fati.tizvir75@gmail.com Islamic Azad University scientific Fatemeh tizvir
No. 67, Khalij Fars 3 Street, End of Aria Boulevard, Baharestan, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 6137785418 0098613372722238 fati.tizvir75@gmail.com Islamic Azad University Iran (Islamic Republic of) Female student enrolled in middle or high school Age between 12 to 18 years Low score in mindfulness and social self-efficacy Willingness to participate in the study (informed consent) Not currently receiving other psychological interventions High score in a social anxiety scale 12 years 18 years Female Diagnosis of severe psychiatric disorders (e.g.,psychosis,bipolar disorder) Concurrent use of psychiatric medications affecting mood or anxiety Participation in other psychological interventions simultaneously Missing more than two interventions sessions Inability to understand intervention content or cooperate properly (based on researcher's judgment) F40.1 Social phobias Treatment - Other Other Intervention group: Consisted of 15 female students with social anxiety disorder who received compassion-focused therapy over 8 weekly sessions. Control group: Consisted of 15 female students without receiving any intervention. MindfulnessOutcome Description:The level of mindfulness in participants will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ). This 39-item instrument evaluates the dimensions of observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Timepoint: The pre-test was conducted one week before the beginning of the therapy sessions, the post-test was conducted immediately after the eighth session, and the follow-up was conducted one month after the end of the intervention. Method of measurement: The mindfulness variable was measured using the Five Facet Mindfulness Questionnaire (FFMQ) at three stages (pre-test, post-test, and follow-up). Social Self-EfficacyOutcome Description:The level of social self-efficacy will be measured using the Social Self-Efficacy Questionnaire developed by Sherer and Maddux (1982), consisting of 17 items. This tool assesses an individual’s ability to interact effectively in social situations and their confidence in social interactions. Timepoint: The pre-test was conducted one week before the beginning of the therapy sessions, the post-test was conducted immediately after the eighth session, and the follow-up was conducted one month after the end of the intervention. Method of measurement: The social self-efficacy variable was measured using the Sherer and Maddux Social Self-Efficacy Scale at three stages (pre-test, post-test, and follow-up). Islamic Azad University, Ahvaz Branch Approved 2024-11-11 Ethics Committee of Islamic Azad University,Ahvaz Branch Islamic Azad University of Ahvaz, Farhangshahr, Golestan Blvd., Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)