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IRCT20260107068587N1 IRCT 2026-01-27 Rah-e Zendegi Psychological Clinics, affiliated with the Imam Khomeini Relief Foundation (IRF) Effect of a Neurophenomenological Intervention on Social Anxiety in Adolescents NATB Neurophenomenological Transformation in Adolescents with Social Anxiety Disorder: Comparing the Effectiveness of a Neural–Embodied Regulation Intervention versus Another Therapeutic Intervention in Improving Interoceptive Markers 2026-01-29 anticipated 38 Complete https://irct.ir/trial/88709 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This study is a single-arm interventional clinical trial with a pretest–posttest design in which all eligible participants will receive the neurophenomenological neural–embodied regulation intervention delivered in an 8-session protocol. Primary outcomes, including interoceptive markers and social anxiety severity, will be assessed at baseline and after completion of the intervention. In addition, a qualitative component will be conducted to explore participants’ lived experiences of bodily and emotional changes throughout the treatment process. N/A Adolescent Social Anxiety Disorder. Intervention group: An individual, face-to-face autonomic regulation psychotherapy based on Polyvagal Theory and Somatic Experiencing for adolescents with Social Anxiety Disorder. This intervention is delivered at the “Rah-e Zendegi” psychology clinics and consists of eight structured therapeutic sessions. Each session lasts 60 minutes and is provided over a 3-week period (three sessions per week). A 6-month follow-up assessment will also be conducted after completion of the intervention.Session content includes:(1) establishing safety and therapeutic alliance with initial psychoeducation about threat and safety responses;(2) enhancing interoceptive awareness and identifying bodily anxiety signals;(3) grounding exercises and body-based attentional regulation;(4) autonomic arousal regulation with gradual exposure to age-appropriate social situations;(5) working with threat responses through controlled oscillation between tension and calm states (pendulation);(6) therapist–client co-regulation and relational repair;(7) integrating felt safety into social interactions through body-based interpersonal exercises; and(8) review, consolidation, and relapse-prevention planning.In selected sessions, brief video-assisted recall is used to facilitate embodied reflection on lived experience and bodily changes. The intervention is delivered by trained psychotherapists under supervision. Treatment fidelity is monitored using a standardized checklist, and a randomly selected subset of sessions is reviewed by an independent supervisor. This study includes no pharmacological intervention or consumable substance.. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the sensitive psychological and physiological data collected from adolescents and the need to protect participant confidentiality, there is no plan to publicly share individual participant data.
public Parvaneh Rahmati Sangkar
Unit 4, Second Floor, No. 3, Mazaheri Street, Narmak Square 38, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۶۸۱۹۴۶۵۱۴ +98 21 2390 2489 parvanehrahmati1383@gmail.com Imam Khomeini Relief Foundation scientific Parvaneh Rahmati Sangkar
Unit 4, Second Floor, No. 3, Mazaheri Street, Narmak Square 38, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۶۸۱۹۴۶۵۱۴ +98 21 2390 2489 parvanehrahmati1383@gmail.com Imam Khomeini Relief Foundation Iran (Islamic Republic of) Formal diagnosis of Social Anxiety Disorder based on DSM-5 criteria using the MINI-KID interview Score of 25 or higher on the Social Anxiety subscale of the SCARED questionnaire Score of 3 or higher on the Pubertal Development Scale as an indicator of entry into the target developmental stage Willingness to participate in the treatment program and adherence until completion of the 8-session protocol No use of psychotropic medications during the past 6 months 13 years 18 years Both History of psychotic disorders Moderate to severe neurodevelopmental disorders Confirmed substance use or substance use disorder F40.1 Social phobias Treatment - Other Intervention group: An individual, face-to-face autonomic regulation psychotherapy based on Polyvagal Theory and Somatic Experiencing for adolescents with Social Anxiety Disorder. This intervention is delivered at the “Rah-e Zendegi” psychology clinics and consists of eight structured therapeutic sessions. Each session lasts 60 minutes and is provided over a 3-week period (three sessions per week). A 6-month follow-up assessment will also be conducted after completion of the intervention.Session content includes:(1) establishing safety and therapeutic alliance with initial psychoeducation about threat and safety responses;(2) enhancing interoceptive awareness and identifying bodily anxiety signals;(3) grounding exercises and body-based attentional regulation;(4) autonomic arousal regulation with gradual exposure to age-appropriate social situations;(5) working with threat responses through controlled oscillation between tension and calm states (pendulation);(6) therapist–client co-regulation and relational repair;(7) integrating felt safety into social interactions through body-based interpersonal exercises; and(8) review, consolidation, and relapse-prevention planning.In selected sessions, brief video-assisted recall is used to facilitate embodied reflection on lived experience and bodily changes. The intervention is delivered by trained psychotherapists under supervision. Treatment fidelity is monitored using a standardized checklist, and a randomly selected subset of sessions is reviewed by an independent supervisor. This study includes no pharmacological intervention or consumable substance. Heart rate variability (HRV) as an index of autonomic nervous system regulation, measured by resting RMSSD. Timepoint: Baseline (pre-test; week 0)Post-intervention (post-test; week 3)6-month follow-up after completion of the intervention (approximately week 26). Method of measurement: Heart rate variability is recorded using the BioPac MP150 physiological recording system with a finger photoplethysmography sensor, and the root mean square of successive differences of beat-to-beat intervals is extracted from resting recordings. Skin conductance level (electrodermal activity) as an index of sympathetic autonomic arousal. Timepoint: Baseline (pre-test; week 0); end of intervention (post-test; week 3); 6-month follow-up after the intervention (approximately week 26). Method of measurement: Skin conductance level will be measured using the BioPac MP150 physiological recording system with silver/silver chloride surface electrodes. Severity of social anxiety symptoms based on the social anxiety subscale score of the Screen for Child and Adolescent Anxiety Related Emotional Disorders questionnaire (SCARED; Birmaher et al., 1999). Timepoint: Baseline (pre-test; week 0); end of intervention (post-test; week 3); six-month follow-up after the intervention (approximately week 26). Method of measurement: Screen for Child and Adolescent Anxiety Related Emotional Disorders questionnaire (SCARED; Birmaher et al., 1999), social anxiety subscale. Severity of social avoidance based on the social avoidance subscale score of the Screen for Child and Adolescent Anxiety Related Emotional Disorders questionnaire (SCARED; Birmaher et al., 1999). Timepoint: Baseline (pre-test; week 0); end of intervention (post-test; week 3); six-month follow-up after the intervention (approximately week 26). Method of measurement: Screen for Child and Adolescent Anxiety Related Emotional Disorders questionnaire (SCARED; Birmaher et al., 1999), social avoidance subscale. Rah-e Zendegi Psychological Clinics, affiliated with the Imam Khomeini Relief Foundation (IRF) Approved 2025-11-05 Ethics Committee of Islamic Azad University of Medical Sciences, Qom Branch 15 Khordad Blvd., Islamic Azad University of Medical Sciences, Qom Branch, Qom, Iran Qom Ghoum Iran (Islamic Republic of)