UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030620 |
|---|---|
| Receipt number | R000034965 |
| Scientific Title | A randomized controlled trial of cognitive behavioral therapy for irritable bowel syndrome using complementary psychoeducational video |
| Date of disclosure of the study information | 2017/12/28 |
| Last modified on | 2024/04/17 13:29:41 |
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Basic information
Public title
A randomized controlled trial of cognitive behavioral therapy for irritable bowel syndrome using complementary psychoeducational video
Acronym
A randomized controlled trial of the cognitive behavioral therapy for irritable bowel syndrome
Scientific Title
A randomized controlled trial of cognitive behavioral therapy for irritable bowel syndrome using complementary psychoeducational video
Scientific Title:Acronym
A randomized controlled trial of the cognitive behavioral therapy for irritable bowel syndrome
Region
| Japan |
Condition
Condition
Irritable bowel syndrome
Classification by specialty
| Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effectiveness of cognitive behavioral therapy compared with treatment as usual only(TAU alone) for irritable bowel syndrome in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The Japanese version of the irritable bowel syndrome-severity index (IBSSI-J)
Key secondary outcomes
1.Visceral sensitivity index(VSI)
2.IBS-Global Improvement Scale(IBS-GIS)
3.The Japanese version of the irritable bowel syndrome quality of life instrument(IBS-QOL-J)
4.Medical Outcome Study 36-item Short Form Health Survey (SF-36)
5.Beck Depression Inventory-Second Edition (BDI-2)
6.State Trait Anxiety Inventory(STAI)
7.IBS Diary
8.Body Vigilance Scale(BVS)
9.Cognitive control scale
10.Patient characteristics information
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive Behavioral Therapy for irritable bowel syndrome (Once a week, 10 sessions) and treatment as usual(TAU) including drug therapy and lifestyle advice.
Interventions/Control_2
Treatment as usual (TAU) for Irritable bowel syndrome including drug therapy and lifestyle advice.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons diagnosed with irritable bowel syndrome based on the Rome 4 diagnostic criteria
2.Those whose severity is moderate or severe(IBSSI-J score =>175 and over)
3.Persons who can understand the purpose and contents of this trial and give voluntary written an informed consent.
Key exclusion criteria
1.Person in whom organic disease is suggested by the presence of warning symptoms*.
2.Persons with a history of or concomitant inflammatory bowel disease, malignant tumor, or other bowel disease which could cause the current bowel symptoms.
3.Persons suffering from major psychiatric disease, such as psychotic disorders, bipolar disorder, substance abuse-related disorders, eating disorders, obsessive and compulsive disorders,or PTSD (persons with anxiety disorders, somatic symptom and related disorders and depression without suicidal ideation are not excluded)
4.Persons with antisocial personality disorders.
5.Persons observed to have significant suicidal ideation at screening.
6.Persons with another past or present psychiatric or physical disease that is likely to interfere with continuation and evaluation of the study.
7. Persons experiencing any other type of marked chronic pain.
8.Those taking narcotic analgesics.
9.Persons who anticipate difficulty attending 10 sessions as an outpatient during the 16-week CBT implementation period.
10.Those who have previously received structured individual CBT.
11.Those for whom verbal and written communication in Japanese is not possible
12.Pregnant or lactating women.
13. Any other person whom the principal investigator has determined to be unsuitable as a participant of the study.
*Warning symptoms list.
1.Symptoms which first appeared after 50 years of age.
2.Any rectal bleeding that has not undergone sufficient medical investigation (excluding that caused by known hemorrhoids).
3.Diarrhea-predominant IBS in which no colonoscopy investigation has been conducted.
4.Unexplained weight loss without a change in eating habits.
5.Nocturnal symptoms sufficient to cause insomnia.
6.The presence of warning symptoms (anemia, inflammatory reactions, or fecal occult blood).
7.Persons with a family history of colon cancer in a first- or second-degree relative (grandparents, parents, siblings, or children).
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Fukudo |
Organization
Tohoku University
Division name
Tohoku University Hospital, Department of Psychosomatic Medicine
Zip code
980-8574
Address
1-1 Seiryo, Aoba, Sendai 980-8574, Japan
TEL
022-717-7734
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ando |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Behavioral Medicine
Zip code
187-8553
Address
4-1-1 Ogawahigashi, Kodaira, Tokyo 187-8553
TEL
042-341-2711
Homepage URL
andot.ncnp@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University, University of Tokyo, National Center for Global Health and Medicine, Kohnodai Hospital National Center for Global Health and Medicine, International University of Health and Welfare
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
1-1 Seiryo, Aoba, Sendai 980-8574, Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
東北大学(宮城県)、東京大学（東京都）、国立国際医療研究センター病院（東京都）、国立国際医療研究センター国府台病院（千葉県）、国際医療福祉大学病院（栃木県）/Tohoku University, University of Tokyo, National Center for Global Health and Medicine, Kohnodai Hospital National Center for Global Health and Medicine, International University of Health and Welfare Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 28 | 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
33
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034965
