Determining the relationship between transdiagnostic mechanisms, mindfulness, cognitive flexibility, anxiety sensitivity, emotional avoidance, and behavioral avoidance in integrative treatment with psychological distress and severity of gastrointestinal symptoms in patients with irritable bowel syndrome.
Design
A controlled, parallel-group, single-blind, randomized clinical trial on 52 patients. A random number generator will be used for randomization.
Settings and conduct
The study will be conducted in a specialized gastroenterology clinic in Kermanshah. In addition to receiving standard treatments for irritable bowel syndrome, 26 patients in the intervention group will undergo integrated protocol treatment once a week by a clinical psychologist for eight 45-60 minute sessions; and will be compared with 26 patients receiving standard treatments for irritable bowel syndrome as the control group.
Participants/Inclusion and exclusion criteria
Patients with irritable bowel syndrome are a condition for inclusion of the study and bowel surgery is a condition for exclusion.
Intervention groups
The intervention group will receive the Integrated Protocol for Transdiagnostic Treatment. The control group will receive only standard treatments for irritable bowel syndrome, including drug treatments.
Main outcome variables
Severity of clinical symptoms of irritable bowel syndrome, based on scores obtained from the IBS-SSS questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260808070576N1
Registration date:2026-09-20, 1405/06/29
Registration timing:registered_while_recruiting
Last update:2026-09-20, 1405/06/29
Update count:0
Registration date
2026-09-20, 1405/06/29
Registrant information
Name
Hosna Mirzaasgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8878 0464
Email address
hosna.mirzaasgari@sbum.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-03, 1405/05/12
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the effectiveness of Unified Protocol on alleviating psychological distress and digestive symptoms in patients with irritable bowel syndrome
Public title
Investigating the effectiveness of psychotherapy on reducing psychological distress and symptoms of the disease in patients with irritable bowel syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least a high school diploma
A cutoff score of 15 or more on the DASS-21 Depression and Anxiety subscale
Having irritable bowel syndrome
Willingness and consent to participate in the study
Exclusion criteria:
Receiving other psychological treatments in the past year
History of intestinal surgery
Psychotic features or suicidal thoughts
Organic mental disorder
History of drug abuse or drug dependence
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:
54
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 52 eligible patients will be allocated to two intervention and control groups in a 1:1 ratio. The random allocation sequence will be prepared using the Block Randomization method with variable sizes of 4 and 6 and a 1:1 ratio. The allocation sequence will be generated by an individual independent of the recruitment and implementation of the intervention and placed in opaque, non-transparent, sealed, and sequentially numbered envelopes. After meeting the inclusion criteria, obtaining informed consent, and final entry of each patient into the study, the next numbered envelope will be opened by the person responsible for allocation and the patient group will be determined. Thus, group allocation cannot be predicted or selected before the patient's final entry.
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
Ethics committee of shahid beheshti University of Medical Sciences
Street address
No 30 Agha Razi avenue Golestan crossroad
City
tehran
Province
Tehran
Postal code
6714763164
Approval date
2026-08-03, 1405/05/12
Ethics committee reference number
IR.SBMU.MSP.REC.1405.301
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
2
Description of health condition studied
Mixed anxiety and depressive disorder
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
3
Description of health condition studied
Mild depressive episode
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
Score obtained from the IBS-SSS questionnaire
Timepoint
For this purpose, participants must complete the previous module before starting a new module in order to be eligible for the next module intervention. Initially, psychological distress and severity of gastrointestinal symptoms and transdiagnostic mechanisms as mediators (integrated protocol treatment modules) will be assessed as Baseline before the start of treatment (t0). All hypothesized mediators will also be assessed immediately after the module targeting the mechanism to ensure that participants have received the treatment (t1). For mechanisms that will be targeted early in treatment (mindfulness and cognitive flexibility), they will also be assessed after treatment to examine further changes (t2). We will not assess anxiety sensitivity and avoidance at post-treatment due to the close temporal proximity to the assessment of modules 6 and 7 (weeks 6 and 7). We assume that one module is completed each week. Accordingly, we will assess the meta-diagnostic mechanisms in the control group in the week that corresponded to the module number (i.e., we will assess mindfulness after module 3 in the treatment and after 3 weeks in the control group).
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group receives the Integrated Protocol treatment. The Integrated Protocol is a cognitive behavioral therapy with an emotion-focused approach. This treatment is designed to help patients learn how to deal with their unpleasant emotions and respond to their emotions in a more adaptive way. The treatment is delivered in 8 weekly sessions of 50 to 60 minutes. In the first session, the patient's motivation to participate in the treatment is increased. Patients weigh the advantages and disadvantages of change compared to staying the same and express their treatment goals. The topic of the second session is psychological education tracking emotional experiences. The nature of emotions and the main components of emotional experience are introduced to patients. In the third session, patients are taught emotion awareness. Patients become more aware of how they react and respond to emotions. The fourth session is Cognitive Appraisal and Change Appraisal: In this section, patients are taught to consider the role of maladaptive automatic appraisals in creating emotional experiences. Session 5: Avoiding Emotions and Emotional Behaviors: This section emphasizes the components of emotional experience behaviors. In this section of the treatment, therapists help patients identify patterns of avoiding emotions and maladaptive emotional behaviors. Session 6: Awareness of and Tolerance for Physical Feelings: This section emphasizes increasing awareness of the role of physical feelings in emotional experiences. Session 7: Facing Internal and External Triggers of Emotions: This section focuses on internal triggers, including physical and external feelings of emotions, and helps patients increase their tolerance for emotions. Session 8: Relapse Prevention: An overview of treatment concepts and discussion and exchange of opinions about the patient's progress are conducted. Before the start of treatment, in different sessions and at the end of treatment, depending on the topic, questionnaires are completed by the patient to measure psychological distress and digestive symptoms.
Category
Behavior
2
Description
Control group: 26 patients in the control group will receive only the usual medications for the treatment of irritable bowel syndrome and will not receive the psychological treatment of the integrated protocol. Before, during, and at the end of treatment, depending on the subject, questionnaires will be completed by the patient to measure psychological distress and digestive symptoms.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic
Full name of responsible person
Hosna Mirzaasgari
Street address
Golestan
City
kermanshah
Province
Kermanshah
Postal code
6714763164
Phone
+98 83 3839 9308
Email
hosna.mirzaasgari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hosna Mirzaasgari
Street address
, Koodakyar Dead End ,Daneshjoo Boulevard, Yemen Street
City
Tehran
Province
Kermanshah
Postal code
1985717443
Phone
+98 21 2387 2502
Email
hosna.mirzaasgari@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The budget has not been approved.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hosna mirzaasgari
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 30 Agha Razi Avenue Golestan Crossroad
City
کرمانشاه
Province
Kermanshah
Postal code
6714763164
Phone
+98 83 3839 9308
Email
hosna.mirzaasgari@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hosna Mirzaasgari
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 30 Agha razi Avenue Golestan Crossroad
City
kermanshah
Province
Kermanshah
Postal code
6714763164
Phone
+98 83 3839 9308
Email
Hosna.mirzaasgari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Banafsheh Mohajerin
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Koodayyar Dead End, Daneshjoo Boulevard, Yemen Street, Shahid Chamran Highway
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2502
Email
banafshehmohajerin@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
Not applicable
Title and more details about the data/document
All data can be shared after de-identifying individuals.
When the data will become available and for how long
The period of access to data and documents will begin from 1406 onwards.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, as well as to people working in industry, who can apply to receive them.
Under which criteria data/document could be used
They are authorized to receive information and documentation for literature review, data meta-analysis, or any other type of data analysis.
From where data/document is obtainable
To receive information about the corresponding author, Dr. Hosna Mirzaasgari, you can contact her at the following email addresses and phone numbers:
h.m.asgari@hotmail.com
hosna.mirzaasgari@sbmu.ac.ir
09126347604
What processes are involved for a request to access data/document
It is possible to send a request via the mentioned emails, or by calling the mobile phone number, or by sending a message via WhatsApp messenger, and the information will be sent to them within a maximum of 3 weeks.