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IRCT20250703066357N1 IRCT 2025-08-27 Islamic Azad University The effectiveness of cognitive behavioral therapy on feelings of shame and guilt, impulsive behaviors, and difficulty in emotion regulation. The effectiveness of cognitive behavioral therapy on feelings of shame and guilt, impulsive behaviors, and difficulty in emotion regulation in adolescents with high-risk behaviors. 2025-09-20 anticipated 40 Complete https://irct.ir/trial/85752 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In the future study, stratified randomization will be used. The unit of randomization will be the individual, and participants will be divided into strata based on key variables (such as gender and severity of risky behavior). Within each stratum, participants will be assigned to experimental and control groups using block randomization with a block size of 4. The random sequence will be generated using specialized software (such as R or SPSS) and placed in sealed envelopes or an online concealment system to reduce bias, Blinding description: The assessor who measures the primary and secondary outcomes (shame, guilt questionnaires, etc.) will be kept unaware of each participant’s allocation to the intervention or control group. The allocation of participants to groups will be done by an independent collaborator who is not involved in the assessment or intervention process, and the list will be kept confidential. The raw data will be provided to the analyst for statistical analysis, with non-specific codes (e.g. Group 1 and Group 2). The true identity of the groups (experimental or control) will only be revealed to the analyst after the primary final analyses have been completed. Due to the active nature of the psychosocial intervention, participants and therapists will be aware of their group and therefore will not be blinded. N/A Risky behaviors in adolescents. Intervention 1: Intervention group:The intervention will consist of 12 weekly sessions of CBT for adolescents with high-risk behaviors in Ahvaz city, focusing on rebuilding shame and guilt beliefs, training in emotion regulation, and impulse control. The experimental group will receive this intervention, while the control group will only receive routine monitoring. Outcomes will be assessed in three stages: pre-test, post-test, and 3-month follow-up. All sessions will be delivered by trained therapists in selected centers in Ahvaz. Intervention 2: Control group: The control group in this study will not receive any active intervention and will only be monitored by the counseling centers as usual (such as general support sessions without a structured CBT protocol). After the study ends, this group will be given the opportunity to receive the CBT intervention. 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 No further information available.
public Shams Sobhani Joo
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
Ahvaz Iran (Islamic Republic of) 3733361349 +98 61 3334 8420 info@iauahvaz.ac.ir Islamic Azad University scientific Shams Sobhani Joo
Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway
Ahvaz Iran (Islamic Republic of) 3733361349 +98 61 3334 8420 info@iauahvaz.ac.ir Islamic Azad University Iran (Islamic Republic of) Informed consent, interest and willingness of individuals to participate in the research and their parents Ability to read, write, and complete an informed consent form Age range 14 to 17 years The participant exhibits signs of high-risk behaviors and subsequently scores higher than the average on this scale. Adolescents with high-risk behaviors in Ahvaz city 14 years 17 years Both Simultaneous participation in other training and treatments Having chronic physical disorders and not being able to follow up with the subject during the pre-test-post-test stages Z72.9 Problem related to lifestyle, unspecified N/A N/A Intervention group:The intervention will consist of 12 weekly sessions of CBT for adolescents with high-risk behaviors in Ahvaz city, focusing on rebuilding shame and guilt beliefs, training in emotion regulation, and impulse control. The experimental group will receive this intervention, while the control group will only receive routine monitoring. Outcomes will be assessed in three stages: pre-test, post-test, and 3-month follow-up. All sessions will be delivered by trained therapists in selected centers in Ahvaz. Control group: The control group in this study will not receive any active intervention and will only be monitored by the counseling centers as usual (such as general support sessions without a structured CBT protocol). After the study ends, this group will be given the opportunity to receive the CBT intervention. Feeling ashamed. Timepoint: Outcome variables will be measured at three time points: pre-intervention, end of intervention, and 3-month follow-up. Method of measurement: Shame and Guilt Questionnaire by Cohen et al. (2011). Risky behaviors. Timepoint: Risky behaviors will be measured at three time points: before the intervention, three months later, and at the end of the intervention and 3-month follow-up. Method of measurement: High-Risk Behavior Scale (YRBS). Cognitive regulation of emotion. Timepoint: Cognitive emotion regulation will be measured at three time points: before the intervention, at the end of the intervention, and at the 3-month follow-up. Method of measurement: Cognitive Emotion Regulation Questionnaire (CERQ):. Islamic Azad University Approved 2025-08-16 Ethics Committee of Islamic Azad University, Ahvaz Branch Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)