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IRCT20260225068949N1 IRCT 2026-04-27 Esfahan University of Medical Sciences Comparison the Effect of Mindfulness-Based Cognitive Therapy and Progressive Muscle Relaxation on Inflammatory Bowel Disease Patients Comparison the Effect of Mindfulness-Based Cognitive Therapy and Progressive Muscle Relaxation on Symptoms, Fatigue, and Visceral Hypersensitivity in Inflammatory Bowel Disease Patients 2026-08-23 anticipated 72 Complete https://irct.ir/trial/89604 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This Study is a Block Randomization Clinical Trial with Two Intervention Groups and is Conducted in an Unblinded Manner. The Sample of This Design Includes 72 Patients with Inflammatory Bowel Disease. After Reviewing and Evaluating the Files of the Affected Patients and also Evaluating the Patients Diagnosed with Inflammatory Bowel Disease by a Specialist Physician and after Their Agreement to Participate in this Design and also Evaluating the Entry Conditions; with the Help of a Statistical Consultant and Based on Statistical Software; Blocks of 9 Sizes are Created, Which will Ultimately Create 8 Blocks of 9 and 36 Patients will be Placed in Each Group. N/A Condition 1: Inflammatory Bowel Disease (IBD). Condition 2: Inflammatory Bowel Disease (IBD). Intervention 1: Intervention Group 1: This Group of Patients with Inflammatory Bowel Disease (IBD) Received Mindfulness-Based Cognitive Therapy in a Group Setting Over 8 Two-Hour Sessions. Session 1: Introduction and Explanation of the Sessions’ General Content and Awareness and Automatic Guidance Session 2: Living in Our Minds (Paying Attention to Breathing) Session 3: Gathering the Wandering Mind Session 4: Recognizing Aversion Session 5: Allowing/Coping Session 6: Thoughts are not Reality. Session 7: How can I Best Take Care of Myself? Session 8: Retaining and Expanding New Learning. Also, at the End of Each Session, There are a Series of Exercises That are Given to The Patient to Study and Do for The Next Session. Intervention 2: Intervention group 2: This Group of Patients with Inflammatory Bowel Disease (IBD) Received Progressive Muscle Relaxation in 8 Two-Hour Sessions as a Group. Session 1: Justification of The Treatment Logic and Breathing Relaxation Session 2: Relaxation of 16 Muscle Groups Session 3: Relaxation of 7 Muscle Groups Session 4: Relaxation of 4 Muscle Groups Session 5: Relaxation Through Reminders Session 6: Relaxation Through Reminders with Counting Session 7: Relaxation Through Counting Session 8: Final Feedback on The Intervention Process and Post-Test At The Beginning of Each Session, Questions from Individuals about the Previous Session are Answered, and at The End of The Sessions, Guidance is Provided on How to Complete Assignments. Yes - There is a plan to make this available What will be shared: All Data about Participants Can be Shared After Individuals are De-identified. When: Access Period Starts 6 Months After Results are Published To whom: Researchers Working in Academic and Scientific Institutions Conditions: The Data is Provided Solely for The Purpose of Better Understanding The Research Methodology. Therefore, Analysis of The Data is not Permitted. Where to obtain: Sara Ahmadi: Sa.Ahmadi.9731@gmail.com Phone: 09367581699 Dr. Fatemeh Zargar: fatemehzargar@gmail.com How to obtain: First, Send an Email to Ms. Ahmadi. If You do not Receive a Response from The University Email, Send a Message to Her Personal Email. Otherwise, Send a Message to Dr. Fatemeh Zargar's Email. We Will Try to Respond Within a Week. Comments:
public Sara Ahmadi
Isfahan University of Medical Sciences, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 81458-33117 +98 31 3792 8101 Sa.Ahmadi.9731@gmail.com Esfahan University of Medical Sciences scientific Dr. Fatemeh Zargar
Isfahan University of Medical Sciences, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8101 fatemehzargar@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Possessing Minimum Age of 18 Years and a Maximum Age of 65 Years Definitive Diagnosis of Crohn's Disease or Ulcerative Colitis by a Specialist physician Ability to Participate in 8 Treatment Sessions Having at Least a High School Diploma Completing the Informed Consent Form Ability to Perform Light Exercise Like Raising Arms Above Head or Bending Knees 18 years 65 years Both Having Major Psychiatric Disorder Such as Psychotic Disorders, Substance Use Disorders, Mood disorders Participation in Other Psychosocial Trials K50 K51 Crohn's disease [regional enteritis] Ulcerative colitis Lifestyle Lifestyle Intervention Group 1: This Group of Patients with Inflammatory Bowel Disease (IBD) Received Mindfulness-Based Cognitive Therapy in a Group Setting Over 8 Two-Hour Sessions. Session 1: Introduction and Explanation of the Sessions’ General Content and Awareness and Automatic Guidance Session 2: Living in Our Minds (Paying Attention to Breathing) Session 3: Gathering the Wandering Mind Session 4: Recognizing Aversion Session 5: Allowing/Coping Session 6: Thoughts are not Reality. Session 7: How can I Best Take Care of Myself? Session 8: Retaining and Expanding New Learning. Also, at the End of Each Session, There are a Series of Exercises That are Given to The Patient to Study and Do for The Next Session. Intervention group 2: This Group of Patients with Inflammatory Bowel Disease (IBD) Received Progressive Muscle Relaxation in 8 Two-Hour Sessions as a Group. Session 1: Justification of The Treatment Logic and Breathing Relaxation Session 2: Relaxation of 16 Muscle Groups Session 3: Relaxation of 7 Muscle Groups Session 4: Relaxation of 4 Muscle Groups Session 5: Relaxation Through Reminders Session 6: Relaxation Through Reminders with Counting Session 7: Relaxation Through Counting Session 8: Final Feedback on The Intervention Process and Post-Test At The Beginning of Each Session, Questions from Individuals about the Previous Session are Answered, and at The End of The Sessions, Guidance is Provided on How to Complete Assignments. Symptoms. Timepoint: Before the Intervention, After the Intervention, 3 Months After the Intervention. Method of measurement: Inflammatory Bowel Disease Questionnaire-Short Form. Fatigue. Timepoint: Before the Intervention, After the Intervention, 3 Months After the Intervention. Method of measurement: Multidimensional Fatigue Inventory. Visceral Hypersensitivity. Timepoint: Before the Intervention, After the Intervention, 3 Months After the Intervention. Method of measurement: Visceral Sensitivity Index. Esfahan University of Medical Sciences Approved 2026-02-08 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Building No. 3, Isfahan University of Medical Sciences, Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)