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IRCT20260808070576N1 IRCT 2026-09-20 Shahid Beheshti University of Medical Sciences Investigating the effectiveness of psychotherapy on reducing psychological distress and symptoms of the disease in patients with irritable bowel syndrome. Examining the effectiveness of Unified Protocol on alleviating psychological distress and digestive symptoms in patients with irritable bowel syndrome 2026-08-03 anticipated 54 Recruiting https://irct.ir/trial/92488 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Condition 1: Irritable bowel syndrome. Condition 2: Mixed anxiety and depressive disorder. Condition 3: Mild depressive episode. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. When: The period of access to data and documents will begin from 1406 onwards. To whom: 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. Conditions: They are authorized to receive information and documentation for literature review, data meta-analysis, or any other type of data analysis. Where to obtain: 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 How to obtain: 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. Comments:
public Hosna mirzaasgari
No 30 Agha Razi Avenue Golestan Crossroad
کرمانشاه Iran (Islamic Republic of) 6714763164 +98 83 3839 9308 hosna.mirzaasgari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hosna Mirzaasgari
No 30 Agha razi Avenue Golestan Crossroad
kermanshah Iran (Islamic Republic of) 6714763164 +98 83 3839 9308 Hosna.mirzaasgari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 K58 F41.2 F32.0 Irritable bowel syndrome Mixed anxiety and depressive disorder Major depressive disorder, single episode, mild Behavior Treatment - Drugs 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. 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. 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. The budget has not been approved. Approved 2026-08-03 Ethics committee of shahid beheshti University of Medical Sciences No 30 Agha Razi avenue Golestan crossroad tehran Tehran Iran (Islamic Republic of)