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IRCT20221101056369N1 IRCT 2023-07-25 Iran University of Medical Sciences Effectiveness of Intensive Short term Dynamic Psychotherapy (ISTDP) on the irritable bowel syndrome Effectiveness of Intensive Short term Dynamic Psychotherapy (ISTDP) on the Difficulty in Emotion Regulation, Defense Mechanisms, Quality of Life and Outcome of Treatment in Patients with Irritable Bowel Syndrome 2021-10-07 anticipated 15 Complete https://irct.ir/trial/67954 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Restricted Randomization method of block randomization will be used. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process, so that the number of samples assigned to each of the study groups become equal and in this study, we will have 4 blocks. Random allocation software is used that this random sequence generation software in addition to simple randomization are able to generate random sequence by blocking method. Allocation concealment is also used, which is the method used to execute a random sequence on study participants. In such a way that the assigned group is not known before the individual is assigned. Using Sequentially numbered, sealed, opaque envelopes, each random sequence created is recorded on a card. And the cards are placed in the envelopes of the letter, respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: Evaluator and statistical analysts are blind to the research process. Statistical analyst is blind to research so that data analysis can be done without bias. N/A Irritable bowel syndrome. Intervention 1: Intervention group: Short-term psychodynamic Psychotherapy based on the John Frederickson protocol: At first participants will complete the questionnairs as a pretest. Then they enter the treatment based on the mentioned approach for 6 months. Individual sessions are held weekly. participants will then complete the questionnaires as a post-test. in follow-up phase participants will complete the research questionnaire after 3 months. Intervention 2: Control group: First, the participants complete the research questionnaires as a pre-test. The control group received no intervention. After 6 months, they will complete the questionnaires as a post-test. In the follow-up phase, after 3 months, the participants will complete the research questionnaires again. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr Hossein Keyvani
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 2504 Research-m@iums.ac.ir Iran University of Medical Sciences scientific Faezeh Shafiei
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 0098 66551655 Faezeh.shafiei@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Having irritable bowel syndrome based on the diagnosis of gastroenterologists and Rome III diagnostic criteria age between 20-50 education level at least diploma 20 years 50 years Both Having a significant physical illness based on the interview and history taking from the person Having a severe psychiatric disorder according to the fifth edition of the Diagnostic and Statistical Manual of Mental Illnesses DSM-5 Absence of more than two sessions in treatment K58 Irritable bowel syndrome Treatment - Other Other Intervention group: Short-term psychodynamic Psychotherapy based on the John Frederickson protocol: At first participants will complete the questionnairs as a pretest. Then they enter the treatment based on the mentioned approach for 6 months. Individual sessions are held weekly. participants will then complete the questionnaires as a post-test. in follow-up phase participants will complete the research questionnaire after 3 months. Control group: First, the participants complete the research questionnaires as a pre-test. The control group received no intervention. After 6 months, they will complete the questionnaires as a post-test. In the follow-up phase, after 3 months, the participants will complete the research questionnaires again. Difficulties in emotion regulation. Timepoint: before the intervention, last session 3 months after the intervention. Method of measurement: Difficulties in Emotion Regulation Scale. Irritable bowel syndrome. Timepoint: before the intervention, last session 3 months after the intervention. Method of measurement: Irritable bowel symptoms severity and frequency scale. Defense mechanisms. Timepoint: before the intervention, last session 3 months after the intervention. Method of measurement: Defensive Styles Questionnaire. Quality of life questionnaire. Timepoint: before the intervention, last session 3 months after the intervention. Method of measurement: Quality of life questionnaire. Iran University of Medical Sciences Approved 2021-09-21 Ethics committee of Iran university of Medical Sciences Iran Univesity of Medical Sciences fifth floor Tehran Tehran Iran (Islamic Republic of)