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IRCT20250507065634N7 IRCT 2025-10-22 Islamic Azad University The effectiveness of mindfulness-based cognitive therapy in Individuals with Somatic Symptom Disorder The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) on Alexithymia, Self-Critical Rumination, and Psychological Flexibility in Individuals with Somatic Symptom Disorder 2025-10-25 anticipated 38 Complete https://irct.ir/trial/86385 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Experimental and control groups: After selecting the sample, the next step involves dividing people into experimental and control groups using a random method. How to perform randomization: First step: After selecting the voluntary sample, all selected people are placed on a list (numbers from one to 38 are assigned to people). Second step: From these people, using a random method with sealed and opaque (numbered) envelopes, individuals are divided into experimental and control groups. Each person randomly selects an envelope and is divided into the corresponding group. N/A Somatic Symptom Disorder. Intervention 1: Control group: 19 participants who meet the inclusion criteria will be randomly assigned to the control group. They will complete the Alexithymia, Self-Critical Rumination, and Psychological Flexibility questionnaires, but no treatment will be given to this group. Intervention 2: Intervention group: 19 people with somatic symptom disorder who refer to psychotherapy centers in Isfahan and meet the inclusion criteria will be randomly assigned to the study as the intervention group. They will complete the alexithymia, self-critical rumination, and psychological flexibility questionnaires as a pre-test. They will then undergo 8 mindfulness-based cognitive therapy sessions based on the Crane 2017 protocol, each session lasting 90 minutes, at the Isfahan Analytical Psychotherapy Center. After completing the sessions, they will complete the alexithymia, self-critical rumination, and psychological flexibility questionnaires as a post-test. Yes - There is a plan to make this available What will be shared: Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals. When: Data can be made available 4 months after the results are published and after personally identifiable information is removed. To whom: The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions. Conditions: Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential. Where to obtain: If you need data, please contact zahrasoltani.tehrani2000@gmail.com How to obtain: After receiving and reviewing the request from the researcher, the request will be responded to as soon as possible. Comments:
public Zahra Soltani Tehrani
No. 14, Shahid Ebrahim Vaezz Alley, Motahari Street, District 4, Tiran County, Isfahan, Iran
Tiran Iran (Islamic Republic of) 8531618591 +98 991 318 0986 zahrasoltani.tehrani2000@gmail.com Islamic Azad University scientific Elhamsadat Binandeh
Islamic Azad University, Najafabad Branch, Daneshgah Boulevard, Najafabad, Isfahan, Iran
Esfahan Iran (Islamic Republic of) ۸۵۱۴۱۴۳۱۳۱ +98 913 269 9043 el.binande@yahoo.com Islamic Azad University Iran (Islamic Republic of) Having somatic symptom disorder Age range between 20 and 50 years Sufficient physical ability to attend the sessions Informed consent and willingness to participate in the research process Minimum literacy level (reading and writing skills) 20 years 50 years Both Receiving any psychological treatment in the control group Presence of acute psychological disorders such as depression or anxiety, according to psychiatric history History of physical illnesses requiring medication or special dietary regimen F48.9 Nonpsychotic mental disorder, unspecified Behavior Behavior Control group: 19 participants who meet the inclusion criteria will be randomly assigned to the control group. They will complete the Alexithymia, Self-Critical Rumination, and Psychological Flexibility questionnaires, but no treatment will be given to this group. Intervention group: 19 people with somatic symptom disorder who refer to psychotherapy centers in Isfahan and meet the inclusion criteria will be randomly assigned to the study as the intervention group. They will complete the alexithymia, self-critical rumination, and psychological flexibility questionnaires as a pre-test. They will then undergo 8 mindfulness-based cognitive therapy sessions based on the Crane 2017 protocol, each session lasting 90 minutes, at the Isfahan Analytical Psychotherapy Center. After completing the sessions, they will complete the alexithymia, self-critical rumination, and psychological flexibility questionnaires as a post-test. Alexithymia. Timepoint: Before intervention and after intervention. Method of measurement: Toronto Emotional Alexithymia Questionnaire. Self-Critical Rumination. Timepoint: Before intervention and after intervention. Method of measurement: The Self-Critical Rumination Questionnaire, Smart et al. Psychological Flexibility. Timepoint: Before intervention and after intervention. Method of measurement: Dennis and Vander-Waal Psychological Flexibility Questionnaire. Islamic Azad University Approved 2025-07-24 Research Ethics Committees of Islamic Azad University- Najafaba Branch Islamic Azad University, Najafabad Branch, Daneshgah Boulevard, Najafabad, Isfahan, Iran Najafabad Isfehan Iran (Islamic Republic of)