Unique ID issued by UMIN | UMIN000030620 |
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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 | 2019/06/05 11:27:59 |
A randomized controlled trial of cognitive behavioral therapy for irritable bowel syndrome using complementary psychoeducational video
A randomized controlled trial of the cognitive behavioral therapy for irritable bowel syndrome
A randomized controlled trial of cognitive behavioral therapy for irritable bowel syndrome using complementary psychoeducational video
A randomized controlled trial of the cognitive behavioral therapy for irritable bowel syndrome
Japan |
Irritable bowel syndrome
Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
Psychiatry |
Others
NO
To examine effectiveness of cognitive behavioral therapy compared with treatment as usual only(TAU alone) for irritable bowel syndrome in Japan.
Efficacy
Confirmatory
1. The Japanese version of the irritable bowel syndrome-severity index (IBSSI-J)
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Behavior,custom |
Cognitive Behavioral Therapy for irritable bowel syndrome (Once a week, 10 sessions) and treatment as usual(TAU) including drug therapy and lifestyle advice.
Treatment as usual (TAU) for Irritable bowel syndrome including drug therapy and lifestyle advice.
16 | years-old | <= |
Not applicable |
Male and Female
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.
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).
120
1st name | Tetsuya |
Middle name | |
Last name | Ando |
National Center of Neurology and Psychiatry
Department of Behavioral Medicine, National Institute of Mental Health
187-8553
4-1-1 Ogawahigashi Kodaira, Tokyo 187-8553, Japan
042-341-2711
ando-t@ncnp.go.jp
1st name | Hitomi |
Middle name | |
Last name | Kawanishi |
National Center of Neurology and Psychiatry
Department of Behavioral Medicine, National Institute of Mental Health
187-8553
4-1-1, Ogawahigashi Kodaira, Tokyo 187-8553, Japan
042-341-2711
hitomi_K@ncnp.go.jp
National Center of Neurology and Psychiatry
National Center of Neurology and Psychiatry
Other
Tohoku University, University of Tokyo, National Center for Global Health and Medicine, Konodai Hospital National Center for Global Health and Medicine
National Center of Neurology and Psychiatry
4-1-1 Ogawahigashi Kodaira, Tokyo 187-8553, Japan
+81423412711
ml_rinrijimu@ncnp.go.jp
NO
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)/Tohoku University, University of Tokyo, National Center for Global Health and Medicine, Konodai Hospital National Center for Global Health and Medicine
2017 | Year | 12 | Month | 28 | Day |
Unpublished
Open public recruiting
2017 | Year | 11 | Month | 29 | Day |
2018 | Year | 04 | Month | 17 | Day |
2019 | Year | 02 | Month | 07 | Day |
2021 | Year | 10 | Month | 31 | Day |
2017 | Year | 12 | Month | 28 | Day |
2019 | Year | 06 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034965
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