Effectiveness of affect regulation treatment on the treatment outcomes of patients with irritable bowel syndrome

Comparing the effectiveness of affect regulation therapy and cognitive behavioral therapy on the severity of gastrointestinal symptoms, visceral sensitivity, executive function, emotional processing and psychological disturbance in patients with irritable bowel syndrome.

Clinical trial, with parallel groups, double-blind, randomized, on 32 patients, with a follow-up period of three months. The permuted random blocking method is used to do randomization.

Patients are included in the study with the referral of a gastroenterologist and with the inclusion criteria. affect regulation therapy and cognitive behavioral therapy is implemented in the form of weekly two-hour sessions at the clinic of the Faculty of Behavioral Sciences and Mental Health in Tehran. The study is double blind. after a general explanation about the goals and obtaining informed consent, the participants are randomly assigned to two intervention groups and will not be informed of which treatment will be implemented for them until the end of the study. Then the data obtained from the research is coded and provided to the analyst.

Inclusion criteria: Diagnosing irritable bowel syndrome Age between 18 and 55 years Literacy level above middle school Exclusion criteria: manic states or psychotic symptoms severe depression Having a drug addiction Severity of disease symptoms high and medium risk level of suicide

For the first intervention group, affect regulation therapy is performed based on Professor Berking's protocol, and for the second intervention group, cognitive behavioral therapy is performed based on Toner's protocol. Both interventions are weekly sessions.

Severity of gastrointestinal symptoms, visceral sensitivity, executive function, emotional processing and psychological disturbance

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.

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.

Informed consent and clinical study report will be shared.

6 months after the results are published

All people

Using the results to improve the quality of life of patients

Samane Soltanabadi Email: samane.soltanabadi@gmail.com Number: 09384701029

Send email or message