Tokyo, March 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060885) titled 'An Exploratory study evaluating the effects of a psychological program designed to modify thinking and behavioral patterns in patients with irritable bowel syndrome, assessed using EEG and psychological measures (CS-FBD and IBS-BRQ)' on March 23.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Saitama Prefectural University
Condition:
Condition - irritable bowel syndrome
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to evaluate the effectiveness of cognitive behavioral therapy (CBT) for patients with irritable bowel syndrome (IBS). In addition, this study seeks to elucidate the underlying mechanisms of its effects from the perspective of the brain-gut interaction. Specifically, this study comprehensively examines the impact of CBT on the alleviation of IBS symptoms, the reduction of psychological and physiological stress, and the normalization of abnormal electroencephalographic activity. Through this multidimensional evaluation, the present study aims to contribute to the development of more effective non-pharmacological treatments for patients with IBS.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - cognitive behavioral therapy
seven sessions, each lasting 50 minutes
Cognitive behavioral therapy consisted of the following components:
1. Psychoeducation
2. Self-monitoring
3. Cognitive restructuring
4. Attention training
5. Relapse prevention
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Gender: Not specified
2. Age: 18 years or older and under 65 years
3. Individuals with symptoms of irritable bowel syndrome (IBS) based on the Rome IV diagnostic criteria
4. Japanese individuals
5. Individuals who are able to understand the purpose and procedures of the study and are willing to participate voluntarily
6. Individuals who are able to provide written informed consent
7. Individuals who are able to participate in all required assessments during the study period (pre-intervention, mid-intervention, post-intervention, and follow-ups at 1, 3, and 6 months)
Key exclusion criteria - 1. People diagnosed with gastrointestinal diseases other than IBS
2. People using electronic medical devices, such as cardiac pacemakers
3. People deemed inappropriate for study participation by the investigators
4. People who are pregnant or breastfeeding
5. People currently participating in other clinical trials
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 24 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069673
Disclaimer: Curated by HT Syndication.
