Protocol summary

Study aim
Determining the Efficacy of Acceptance and Commitment Therapy on Lifestyle, Psychological Flexibility, and Symptom Severity in Individuals with Irritable Bowel Syndrome
Design
A randomized , controlled, parallel- group, phase 2 clinical trial on 42 patients. A table of random numbers is used for randomization.
Settings and conduct
The study is conducted at the specialized gastroenterology clinic of Shahid Beheshti Hospital, where the intervention group receives Acceptance and Commitment Therapy.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Diagnosis of Irritable Bowel Syndrome (IBS) based on the ROME IV criteria. Age between 18 and 65 years, A minimum of a high school diploma for education. Willingness to maintain a stable type and dosage of current medications throughout the study period, Willingness and provision of informed consent to participate in the study, No current suicidal ideation, No current substance abuse or dependenc , No prior history of psychotherapy. Exclusion Criteria:Receiving any psychological treatment interventions within the last year or during the period of the study, Onset of an acute psychiatric or physical illness during the study, Three or more absences or irregular attendance in sessions,The individual's unwillingness to continue with the study.
Intervention groups
The intervention and control groups will consist of individual with Irritable Bowel Syndrome , diagnosed by a gastroenterologist according to the ROME IV criteria
Main outcome variables
This study examines whether Acceptance and Commitment Therapy can change psychological flexibility , lifestyle, and symptom severity in individuals with IBS. it is expected that lifestyle and psychological flexibility will increase and the symptom severity score will decrease.

General information

Reason for update
Acronym
irritable bowel syndrome
IRCT registration information
IRCT registration number: IRCT20250630066306N1
Registration date: 2025-07-15, 1404/04/24
Registration timing: prospective

Last update: 2025-07-15, 1404/04/24
Update count: 0
Registration date
2025-07-15, 1404/04/24
Registrant information
Name
Bahar Shafizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2305
Email address
baharshafeezadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-21, 1404/04/30
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Acceptance and Commitment Therapy on Lifestyle, Psychological Flexibility, and Severity of Symptoms among People with Irritable Bowel Syndrome
Public title
The Efficacy of Acceptance and Commitment Therapy in the Treatment of Irritable Bowel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis IBS based on the criteria of ROME IV Aged between 18 and 65 years Satisfaction and commitment to participate in the study Absence of suicidal thoughts No prior history of psychotherapy
Exclusion criteria:
Get interventions psychological treatment in the past year and the time of the study Three sessions of absence for each patient. Oncet of an acute psychological or somatic condition The individual's unwillingness to continue the session
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: 42
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, to allocate participants to the experimental and control groups, a simple randomization method was used with a table of random numbers. First, a list of eligible participants was prepared, and each individual was assigned a number. Then, by randomly selecting a starting point in the table of random numbers, the numbers were read in sequence. Based on whether the numbers were even or odd, individuals were allocated to the experimental or control group (even numbers for the experimental group and odd numbers for the control group). This method was implemented to prevent bias in allocation and to increase the internal validity of the research.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Individuals are randomly assigned to two intervention and control groups using a random number table. The groups are also matched in terms of the type of medication used and the type of IBS. Patients are asked not to change their lifestyle during the implementation of this intervention and to continue their medical treatment. Then, acceptance and commitment therapy is implemented in 8 sessions of 90 minutes on the experimental group and is not performed on the control group. Finally, the treatment method is compared with the control group in terms of symptom reduction. All participants complete lifestyle and psychological flexibility questionnaires and IBS symptom severity before and after the intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashanپ
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2025-06-08, 1404/03/18
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1404.047

Health conditions studied

1

Description of health condition studied
Irritable Bowel Syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

Primary outcomes

1

Description
Lifestyle
Timepoint
Before and after intervention
Method of measurement
Health-Promoting Lifestyle Profile

2

Description
Psychological Flexibility
Timepoint
Before and after intervention
Method of measurement
Cognitive flexibility inventory

3

Description
Severity Symptoms
Timepoint
Before and after intervention
Method of measurement
IBS-SSS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the intervention group received eight-90 minute sessions of Acceptance and Commitment Therapy
Category
Behavior

2

Description
Control group: Receives no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology Specialty Clinic of Shahid Beheshti Hospital
Full name of responsible person
Bahar Shafizadeh
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
baharshafeezadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Kashan University of Medical Science
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
baharshafeezadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zahra Zanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
z-zanjani2005@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Zanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
z-zanjani2005@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zahra Zanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan,
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
z-zanjani2005@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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