UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060885 |
|---|---|
| Receipt number | R000069673 |
| Scientific Title | A pilot study evaluating the effects of cognitive behavioral therapy for irritable bowel syndrome, assessed using electroencephalography and cognitive-behavioral measures (CS-FBD and IBS-BRQ) |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/10 13:34:50 |
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Basic information
Public title
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)
Acronym
An Exploratory study evaluating the effects of a psychological program for IBS patients using EEG and psychological measures
Scientific Title
A pilot study evaluating the effects of cognitive behavioral therapy for irritable bowel syndrome, assessed using electroencephalography and cognitive-behavioral measures (CS-FBD and IBS-BRQ)
Scientific Title:Acronym
A pilot study evaluating the effects of CBT for IBS using EEG and psychological measures
Region
| Japan |
Condition
Condition
irritable bowel syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. CS-FBD-J (Cognitive Scale for Functional Bowel Disorders)
Measurement method: Self-reported CS-FBD-J questionnaire
Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention
Assessment content: Cognitive responses to functional gastrointestinal disorders
Primary evaluation point: Change in CS-FBD-J score from baseline (pre-intervention) to post-intervention
2. IBS-BRQ-J (Behavioral Responses Questionnaire)
Measurement method: Self-reported IBS-BRQ-J questionnaire
Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention
Assessment content: Behavioral responses related to IBS symptoms
Primary evaluation point: Change in IBS-BRQ-J score from baseline (pre-intervention) to post-intervention
Key secondary outcomes
1. Changes in brain wave patterns
Measurement method: Electroencephalogram (EEG) measurements
Measurement timing: Baseline (pre-intervention), mid-intervention, and post-intervention
Assessment content: Resting-state brain activity and brain activity related to interoceptive processing
2. Change in Irritable Bowel Syndrome Severity Index (IBS-SI) score
Measurement method: Self-reported IBS Severity Index (IBS-SI) questionnaire
Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention
Assessment content: Overall IBS symptom severity, including abdominal pain intensity and frequency, abdominal bloating, satisfaction with bowel habits, and interference with daily life
Primary evaluation point: Change in IBS-SI score from baseline (pre-intervention) to post-intervention
3. Improvement in IBS-specific quality of life (IBS-QOL) score
Measurement method: IBS Quality of Life (IBS-QOL) questionnaire
Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention
4. Changes in psychological measures
Measurement method: Visceral Sensitivity Index (VSI) and Hospital Anxiety and Depression Scale (HADS)
Measurement timing: Baseline (pre-intervention), mid-intervention, post-intervention, and at 1, 3, and 6 months after the completion of the intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Toyohiro |
| Middle name | |
| Last name | Hagaguchi |
Organization
Saitama Prefectural University
Division name
Department of Rehabilitation, Graduate School of Health Sciences
Zip code
343-8540
Address
820, Sannomiya, Koshigaya City, Saitama Prefecture
TEL
048-973-4125
hamaguchi-toyohiro@spu.ac.jp
Public contact
Name of contact person
| 1st name | Mutsumi |
| Middle name | |
| Last name | Kaneko |
Organization
Saitama Prefectural University
Division name
Secretariat, Research and Community Relations
Zip code
343-8540
Address
820, Sannnomiya, Koshigaya City, Saitama Prefecture
TEL
048-973-4120
Homepage URL
shorei@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Saitama Prefectural University
Address
820, Sannnomiya, Koshigaya City, Saitama Prefecture
Tel
0489734120
shorei@spu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069673
