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IRCT20240602061987N1 IRCT 2025-01-20 Iran University of Medical Sciences Effectiveness of affect regulation treatment on the treatment outcomes of patients with irritable bowel syndrome Effectiveness of affect regulation treatment on the treatment outcomes of patients with irritable bowel syndrome 2025-02-19 anticipated 32 Complete https://irct.ir/trial/77165 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The permuted random blocking method is used to do randomization. In this method, 8 blocks of 4 will be randomly selected from a combination of letters A and B. These blocks are as follows AABB, ABBA, BBAA, BAAB, ABAB, and BABA. Allocating the letters A and B to the intervention and control groups will be done randomly before randomization and the data analyst will be unaware of the intervention and control groups. The researcher, having a list of people (a list of 48 people who are going to participate in the project), assigns a numeric code to each person. It then offers the anonymous list of members (containing only the numeric code) to the sample assignor to the groups. First, the sample assignor organizes the selected blocks as described, writes them on separate sheets of paper (8 separate sheets), and places them in sealed envelopes. Then s/he randomly selects the envelopes and, based on the previously selected codes, A and B, determines the numerical code number of the individuals assigned to A and B interventions and provides it to the researcher. For instance, if the BABA block is selected first, the first person on the list will be assigned to group B, the second person to group A, the third person to group B, and the fourth person to group A. Likewise, participants 5 to 32 will be assigned to groups A and B, Blinding description: In order to blind the participants, after the general explanation of the treatment and the purpose of the research and obtaining informed consent, the participants are randomly divided into two intervention groups, but they will not be informed of which intervention group they are in until the end of the treatment Explanations are given about the interventions. In order to blind the analyzer, a code is assigned to each data. N/A Irritable bowel syndrome. Intervention 1: The first intervention group: Weekly two-hour sessions of affect regulation therapy are conducted according to the protocol of affect regulation therapy (ART) based on the study of Berking and Whitley, 2014.The content of these sessions includes teaching skills such as muscle and breathing relaxation, non-judgmental awareness, acceptance and tolerance, compassionate self-support, emotion analysis and emotion change. Intervention 2: The second intervention group: 12 weekly two-hour sessions of cognitive behavioral therapy are performed based on the Toner protocol.The content of these sessions includes examining thoughts and challenging them and teaching skills such as problem solving and assertiveness. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not made a decision yet due to ethical issues
public Samane Soltanabadi
South Punak St
Tehran Iran (Islamic Republic of) 1476665964 +98 938 470 1029 samane.soltanabadi@gmail.com Iran University of Medical Sciences scientific Samane Soltanabadi
South Punak St
Tehran Iran (Islamic Republic of) 1476665964 +98 938 470 1029 samane.soltanabadi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosing irritable bowel syndrome by a gastroenterologist based on the Rome IV criteria Age between 18 and 55 years Literacy level above middle school 18 years 55 years Both Suffering from manic states or having psychotic symptoms based on SCID (SCID-5-CV) Suffering from severe depression that prevents effective processing of educational concepts according to SCID Having a drug addiction based on the SCID The severity of the disease and symptoms related to irritable bowel syndrome should be such that the person is unable to participate in the sessions (such as bleeding or severe pain), which is measured through a clinical interview. The existence of high and medium risk level of suicide which is measured through interview. K58 Irritable bowel syndrome N/A N/A The first intervention group: Weekly two-hour sessions of affect regulation therapy are conducted according to the protocol of affect regulation therapy (ART) based on the study of Berking and Whitley, 2014.The content of these sessions includes teaching skills such as muscle and breathing relaxation, non-judgmental awareness, acceptance and tolerance, compassionate self-support, emotion analysis and emotion change. The second intervention group: 12 weekly two-hour sessions of cognitive behavioral therapy are performed based on the Toner protocol.The content of these sessions includes examining thoughts and challenging them and teaching skills such as problem solving and assertiveness. Severity of gastrointestinal symptoms. Timepoint: beginning and end and three months after the end of treatment. Method of measurement: Gastrointestinal Syndrome Rating Scale of Revicki (1998). Visceral Sensitivity. Timepoint: beginning and end and three months after the end of treatment. Method of measurement: Visceral Sensitivity Index of Labus et al. Executive Function. Timepoint: beginning and end and three months after the end of treatment. Method of measurement: Behavior Rating Inventory of Executive Function (BRIEF). Emotional Processing. Timepoint: beginning and end and three months after the end of treatment. Method of measurement: Emotional Processing Scale (EPS) Baker et al. Psychological disturbances. Timepoint: beginning and end and three months after the end of treatment. Method of measurement: Depression Anxiety Stress Scales-Short Form (DASS-21). Iran University of Medical Sciences Approved 2024-03-11 Research Ethics Committees of Iran University of Medical Sciences Tehran, Iran University of Medical Sciences, Hemet Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)