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IRCT20250808066787N1 IRCT 2025-09-09 Islamic Azad University, Rasht Branch The Effectiveness of Schema Therapy Mode Model on Tension, Distress Tolerance and Executive Functions in patients with Psychosomatic Symptoms The Effectiveness of Schema Therapy Mode Model on Tension, Distress Tolerance and Executive Functions in patients with Psychosomatic Symptoms in Rasht city 2025-09-21 anticipated 30 Complete https://irct.ir/trial/85438 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After collecting information from the target population, from the list of patients through systematic sampling, necessary contacts and coordination were made to attend the study and treatment sessions, and after that, the eligible samples, after being selected, will be allocated to two control and intervention groups through a simple random method. For concealment, we use Allocation Concealment, which refers to the method used to perform a random sequence on study participants in a way that the assigned group is not known before the individual is allocated. Using opaque sealed envelopes with a random sequence, in this method (Sealed, Sequentially, Envelopes, Numbered), each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain the random sequence, numbering is also done on the outer surface of the envelopes in the same order. Finally, the lids of the envelopes are glued and placed in a box in order. At the start of participant registration, based on the order in which eligible participants enter the study, one of the envelopes is opened in order and the assigned group of that participant is revealed, Blinding description: In the present study, the experimental group was administered a Schema Therapy Mode Model protocol for 8 2-hour sessions, but the control group did not receive any intervention (in order to comply with research ethics, the control group will receive the intervention after the study is completed). Valid questionnaires (valid and reliable) were used at all stages to measure Tension, distress tolerance, and executive functions of the subjects. In this study, one-way blinding was used, such that the participants were not aware of their allocation to the experimental or control groups. This was done by not disclosing the type of intervention to the participants and also by using the same instructions for completing the questionnaires. The researchers and therapists were aware of the grouping of the subjects, but the participants remained unaware of this until the end of the research process to prevent their expectations from affecting the results. N/A Psychosomatic disorders. Intervention 1: Intervention group: Mindfulness-based schema therapy (STMM); The statistical population of this study consists of psychosomatic patients in Rasht city treatment centers in 1404. 30 people from the aforementioned population will be randomly selected and allocated to two groups (15 people in the experimental group and 15 people in the control group). The following protocol and tools will be used in relation to the therapeutic intervention and data collection: The experiment in this study is called Mindfulness-based schema therapy intervention, which is implemented by an experienced therapist and under the direct supervision of an expert supervisor. The intervention protocol consists of 8 120-minute sessions, which is based on Rosie Robesy's book entitled "Stage-Based Schema Therapy: Goal Setting, Tasks, and Techniques in Individual and Group Schema Therapy." All participants complete a standard questionnaire consisting of demographic information items, Takata and Sakata Psychosomatic Disorders Questionnaire, Short Executive Functioning Scale (SEFS) for Work, Cohen's Perceived Stress Scale (PSS-10), and Simmons and Gahr Distress Tolerance Scale as a pre-test, and the experimental group undergoes mindfulness-based schema therapy training. They are provided with a consent form to participate in the study, and necessary explanations are provided about the purpose and structure of the treatment, the emphasis on completing assignments, and how the sessions are held, and the questions and ambiguities of the people present in the study are answered. Therefore, the participants are mentally prepared to attend the treatment sessions, and a post-test will be administered after the end of the intervention period. A 45-day follow-up period is also conducted to determine the sustainability of the treatment effects. Intervention 2: Control group: The statistical population of this study consists of psychosomatic patients attending medical centers in Rasht in 1404. 30 people from the aforementioned population will be randomly selected and assigned to two groups (15 in the experimental group and 15 in the control group). All participants will complete a standard questionnaire consisting of demographic information items, Takata and Sakata Psychosomatic Disorders Questionnaire, Short Executive Function Scale (SEFS) of Work, Cohen's Perceived Stress Scale (PSS-10), and Simmons and Gaher Distress Tolerance Scale as a pre-test; but the control group will not be trained in mindfulness-based schema therapy. They will be provided with a consent form to participate in the study, and the necessary explanations will be provided regarding the purpose and structure of the study, emphasizing the method of conducting the research stages, and the questions and ambiguities of the people present in the study will be answered. Therefore, the participants will be mentally prepared to participate in the study, and a post-test will be administered after the end of the study. A 45-day follow-up period will also be conducted to determine the sustainability of the treatment effects. (To comply with research ethics, the control group will receive the intervention after the research is completed). No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the sensitive and confidential nature
public Mojgan Asadi Louyeh
End of Shaghayegh Street, Islamic Azad University of Lahijan
لاهیجان Iran (Islamic Republic of) 1616 +98 13 4122 9081 m_asadi69@yahoo.com Islamic Azad University scientific Mojgan Asadi Louyeh
End of Shaghayegh Street, Islamic Azad University of Lahijan
Lahijan Iran (Islamic Republic of) 1616 +98 13 4122 9081 m_asadi69@yahoo.com Islamic Azad University Iran (Islamic Republic of) Received a diagnosis of psychosomatic disorders and psychosomatic symptoms by a psychologist according to DSM-5 criteria and research questionnaire Achieving a minimum average score on the stress scale No specific medical problems (symptoms should not have a medical cause) Not taking psychiatric medications Not participating in other group treatments or individual psychological therapy at the same time as the study 20 years 45 years Both Not willing to continue cooperation Having a psychotic disorder Absent more than two sessions Concurrent medication use Not completing more than 10% of the questions in the questionnaires F50-F59 Unspecified behavioural syndromes associated with physiological disturbances and physical factors Treatment - Other Treatment - Other Intervention group: Mindfulness-based schema therapy (STMM); The statistical population of this study consists of psychosomatic patients in Rasht city treatment centers in 1404. 30 people from the aforementioned population will be randomly selected and allocated to two groups (15 people in the experimental group and 15 people in the control group). The following protocol and tools will be used in relation to the therapeutic intervention and data collection: The experiment in this study is called Mindfulness-based schema therapy intervention, which is implemented by an experienced therapist and under the direct supervision of an expert supervisor. The intervention protocol consists of 8 120-minute sessions, which is based on Rosie Robesy's book entitled "Stage-Based Schema Therapy: Goal Setting, Tasks, and Techniques in Individual and Group Schema Therapy." All participants complete a standard questionnaire consisting of demographic information items, Takata and Sakata Psychosomatic Disorders Questionnaire, Short Executive Functioning Scale (SEFS) for Work, Cohen's Perceived Stress Scale (PSS-10), and Simmons and Gahr Distress Tolerance Scale as a pre-test, and the experimental group undergoes mindfulness-based schema therapy training. They are provided with a consent form to participate in the study, and necessary explanations are provided about the purpose and structure of the treatment, the emphasis on completing assignments, and how the sessions are held, and the questions and ambiguities of the people present in the study are answered. Therefore, the participants are mentally prepared to attend the treatment sessions, and a post-test will be administered after the end of the intervention period. A 45-day follow-up period is also conducted to determine the sustainability of the treatment effects. Control group: The statistical population of this study consists of psychosomatic patients attending medical centers in Rasht in 1404. 30 people from the aforementioned population will be randomly selected and assigned to two groups (15 in the experimental group and 15 in the control group). All participants will complete a standard questionnaire consisting of demographic information items, Takata and Sakata Psychosomatic Disorders Questionnaire, Short Executive Function Scale (SEFS) of Work, Cohen's Perceived Stress Scale (PSS-10), and Simmons and Gaher Distress Tolerance Scale as a pre-test; but the control group will not be trained in mindfulness-based schema therapy. They will be provided with a consent form to participate in the study, and the necessary explanations will be provided regarding the purpose and structure of the study, emphasizing the method of conducting the research stages, and the questions and ambiguities of the people present in the study will be answered. Therefore, the participants will be mentally prepared to participate in the study, and a post-test will be administered after the end of the study. A 45-day follow-up period will also be conducted to determine the sustainability of the treatment effects. (To comply with research ethics, the control group will receive the intervention after the research is completed). Psychosomatic symptoms. Timepoint: Pre-test, post-test, follow-up. Method of measurement: Psychosomatic Complaints Inventory (PCI). Tension. Timepoint: Pre-test, post-test, follow-up. Method of measurement: Perceived Stress Scale-10 (PSS-10). Distress Tolerance. Timepoint: Pre-test, post-test, follow-up. Method of measurement: Distress Tolerance Scale (DTS). Executive Function. Timepoint: Pre-test, post-test, follow-up. Method of measurement: Short Executive Function Scale (SEFS). Islamic Azad University, Rasht Branch Approved 2025-07-08 Research Ethics Committees of Islamic Azad University-lahijan branch Sarpol Sharqi, Valiasr Street, corner of Kharazmi Alley Roudsar Guilan Iran (Islamic Republic of)