Comparison the Effect of Mindfulness-Based Cognitive Therapy and Progressive Muscle Relaxation on Symptoms, Fatigue, and Visceral Hypersensitivity in Inflammatory Bowel Disease Patients
A Comparative Study of The Effects of Mindfulness-Based Cognitive Therapy and Progressive Muscle Relaxation on Symptoms, Fatigue, and Visceral Hypersensitivity in Inflammatory Bowel Disease Patients
Design
This Study is a Randomized Block Clinical Trial with Two Intervention Groups and Three Stages of Pre-Test, Post-Test and Follow-Up. It Will be Conducted in an Unblinded Manner on 72 Patients with Inflammatory Bowel Disease (2 Intervention Groups of 36). Patients Will be Included in The Study if They Agree and are Eligible and Will be Randomly Assigned to The Two Intervention Groups. (Randomized)
Settings and conduct
The Trial Will be Conducted on Patients with Inflammatory Bowel Disease at The Porsina Hakim Clinic, Isfahan. Individuals Participating in The Intervention Groups Will Receive Mindfulness-Based Cognitive Therapy and Progressive Muscle Relaxation in a Group Setting for 8 2-Hour Sessions (2 Months).
Participants/Inclusion and exclusion criteria
Entry conditions:
1) Possessing Minimum Age of 18 Years and a Maximum Age of 65 Years
2) Definitive Diagnosis of Crohn's Disease or Ulcerative Colitis by a Specialist physician, 3) Ability to Participate in 8 Treatment Sessions, 4) Having at Least a High School Diploma, 5) Completing the Informed Consent Form
6) Ability to Perform Light Exercise
Non-entry conditions:
1) Having Major Psychiatric Disorders, 2) Participation in Other Psychosocial Trials
Intervention groups
Intervention Group One: They Will Receive Mindfulness-Based Cognitive Therapy. This Treatment Will Consist of 8 Two-Hour Sessions and Will be Delivered in a Group Setting.
Intervention Group Two: They Will Receive Progressive Muscle Relaxation. This Will Consist of 8 Two-Hour Sessions and Will be Delivered in a Group Setting.
Main outcome variables
Symptoms, Fatigue, and Visceral Hypersensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260225068949N1
Registration date:2026-04-27, 1405/02/07
Registration timing:prospective
Last update:2026-04-27, 1405/02/07
Update count:0
Registration date
2026-04-27, 1405/02/07
Registrant information
Name
Sara Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 7012
Email address
sa.ahmadi.9731@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2026-10-23, 1405/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Mindfulness-Based Cognitive Therapy and Progressive Muscle Relaxation on Symptoms, Fatigue, and Visceral Hypersensitivity in Inflammatory Bowel Disease Patients
Public title
Comparison the Effect of Mindfulness-Based Cognitive Therapy and Progressive Muscle Relaxation on Inflammatory Bowel Disease Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Having Major Psychiatric Disorder Such as Psychotic Disorders, Substance Use Disorders, Mood disorders
Participation in Other Psychosocial Trials
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Building No. 3, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2026-02-08, 1404/11/19
Ethics committee reference number
IR.MUI.MED.REC.1404.453
Health conditions studied
1
Description of health condition studied
Inflammatory Bowel Disease (IBD)
ICD-10 code
K50
ICD-10 code description
Crohn's disease [regional enteritis]
2
Description of health condition studied
Inflammatory Bowel Disease (IBD)
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Symptoms
Timepoint
Before the Intervention, After the Intervention, 3 Months After the Intervention
Method of measurement
Inflammatory Bowel Disease Questionnaire-Short Form
2
Description
fatigue
Timepoint
Before the Intervention, After the Intervention, 3 Months After the Intervention
Method of measurement
Multidimensional Fatigue Inventory
3
Description
Visceral Hypersensitivity
Timepoint
Before the Intervention, After the Intervention, 3 Months After the Intervention
Method of measurement
Visceral Sensitivity Index
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Lifestyle
2
Description
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.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hakim clinic & lab
Full name of responsible person
Sara Ahmadi
Street address
3rd Floor, Isfahan Health Town, Sepehr Street, Aghababaei Highway
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3554 8151
Email
pddrc.com@gmail.com
Web page address
https://clinicpoursina.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Web page address
https://mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sara Ahmadi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81458-33117
Phone
+98 31 3792 8101
Email
Sa.Ahmadi.9731@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Zargar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8101
Email
fatemehzargar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sara Ahmadi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 15, East First Reyhaneh Alley, Hamed Street, Imam Ali Square
City
Semnan
Province
Semnan
Postal code
3519783634
Phone
+98 23 3346 7012
Email
Sa.Ahmadi.9731@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All Data about Participants Can be Shared After Individuals are De-identified.
When the data will become available and for how long
Access Period Starts 6 Months After Results are Published
To whom data/document is available
Researchers Working in Academic and Scientific Institutions
Under which criteria data/document could be used
The Data is Provided Solely for The Purpose of Better Understanding The Research Methodology. Therefore, Analysis of The Data is not Permitted.
From where data/document is obtainable
Sara Ahmadi: Sa.Ahmadi.9731@gmail.com Phone: 09367581699 Dr. Fatemeh Zargar: fatemehzargar@gmail.com
What processes are involved for a request to access data/document
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.