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IRCT20250604066062N1 IRCT 2025-07-22 Esfahan University of Medical Sciences Comparison of the efficacy of schema therapy and mindfulness-based cognitive therapy on symptoms, anxiety sensitivity and sleep quality in patients with irritable bowel syndrome. Comparison of the efficacy of schema therapy and mindfulness-based cognitive therapy on symptoms, anxiety sensitivity and sleep quality in patients with irritable bowel syndrome. 2025-08-01 anticipated 45 Complete https://irct.ir/trial/84165 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization - will be randomly assigned to intervention and control groups, and patients will be randomly assigned to three groups of 15 after meeting the entry criteria. The random selection method will be done by lottery and a number will be assigned to each of the sample people, and then the numbers will be randomly selected with the help of Excel software, which will form the test group. N/A Irritable bowel syndrome. Intervention 1: Intervention group: 10 group schema therapy sessions of Jeffrey Young's schema therapy protocol every week for 90 minutes. The intervention was designed according to the principles of the cognitive-emotional model of schema therapy and included the identification and modification of early maladaptive schemas, activation of maladaptive coping styles, and enhancement of adaptive coping strategies using cognitive, emotional, experiential (e.g., empty-chair technique, guided imagery), behavioral, and interpersonal techniques. Intervention 2: Intervention group: 10 sessions of cognitive-based mindfulness group training each week for 90 minutes. The program included practices such as body scan, mindful breathing, mindful walking, thought meditation, and emotional acceptance. Sessions were conducted in groups and facilitated by a therapist trained in the MBCT approach. To enhance the effectiveness of the program, daily home practice (30 to 45 minutes per day) was also assigned to participants. Intervention 3: Control group: waiting list. After the completion of the study, participants in this group will be given the opportunity to take part in one of the intervention programs. 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 more information is available
public Shaghayegh Bazargan
No 8, homes Alley, North Towhid Street
Esfahan Iran (Islamic Republic of) 8158987864 +98 31 3625 8583 Miss.shaghayegh@gmail.com Esfahan University of Medical Sciences scientific Shaghayegh Bazargan
No 8, homes Alley, North Towhid Street
Esfahan Iran (Islamic Republic of) 8158987864 +98 31 3625 8583 Miss.shaghayegh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) patients with irritable bowel syndrome 18 years no limit Both History of psychotherapy Taking psychiatric drugs K58 Irritable bowel syndrome Treatment - Other Treatment - Other Treatment - Other Intervention group: 10 group schema therapy sessions of Jeffrey Young's schema therapy protocol every week for 90 minutes. The intervention was designed according to the principles of the cognitive-emotional model of schema therapy and included the identification and modification of early maladaptive schemas, activation of maladaptive coping styles, and enhancement of adaptive coping strategies using cognitive, emotional, experiential (e.g., empty-chair technique, guided imagery), behavioral, and interpersonal techniques. Intervention group: 10 sessions of cognitive-based mindfulness group training each week for 90 minutes. The program included practices such as body scan, mindful breathing, mindful walking, thought meditation, and emotional acceptance. Sessions were conducted in groups and facilitated by a therapist trained in the MBCT approach. To enhance the effectiveness of the program, daily home practice (30 to 45 minutes per day) was also assigned to participants. Control group: waiting list. After the completion of the study, participants in this group will be given the opportunity to take part in one of the intervention programs. High score on the Irritable Bowel Symptom Severity Questionnaire. Timepoint: Before the start of the intervention, after the end of the intervention, and 3 months after the end of the intervention. Method of measurement: Francis et al. Irritable Bowel Syndrome Severity Questionnaire. Revised Anxiety Sensitivity Inventory. Timepoint: Before the start of the intervention, after the end of the intervention, and 3 months after the end of the intervention. Method of measurement: Taylor and Cox's Revised Anxiety Sensitivity Inventory. Score on the sleep quality questionnaire. Timepoint: Before the start of the intervention, after the end of the intervention, and 3 months after the end of the intervention. Method of measurement: Petersburg Sleep Quality Questionnaire. Esfahan University of Medical Sciences Approved 2024-08-22 Research Ethics Committees of Islamic Azad University- Najafaba Branch no.8,homa alley,north towhid st esfahan Isfehan Iran (Islamic Republic of)