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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036327
Receipt No. R000041376
Scientific Title Efficacy and feasibility study of the cognitive behavioral therapy program with psychoeducational videos for irritable bowel syndrome
Date of disclosure of the study information 2019/03/29
Last modified on 2019/03/28

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Basic information
Public title Efficacy and feasibility study of the cognitive behavioral therapy program with psychoeducational videos for irritable bowel syndrome
Acronym An open label pilot study of the cognitive behavioral therapy with psychoeducational videos for irritable bowel syndrome
Scientific Title Efficacy and feasibility study of the cognitive behavioral therapy program with psychoeducational videos for irritable bowel syndrome
Scientific Title:Acronym An open label pilot study of the cognitive behavioral therapy with psychoeducational videos 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 feasibility and efficacy of cognitive behavioral therapy with psychoeducational videos for irritable bowel syndrome in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
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.Body vigilance Scale(BVS-J)
8.Effortful Control Scale for Adults
9.Cognitive Control Scale(CCS)
10.Presence or absence of avoidance behavior

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 for Irritable Bowel Syndrome with previewing of psychoeducational video (Once a week, total 10 sessions)
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
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 III diagnostic criteria.
2. Those whose severity is moderate or severe (IBSSI-J score => 175).
3. Persons who can understand the purpose and content of this trial and give voluntary written 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, or eating disorders (persons with anxiety 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 20

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Ando
Organization National Center of Neurology and Psychiatry
Division name Department of Behavioral Medicine, National Institute of Mental Health
Zip code 187-8553
Address 4-1-1 Ogawahigashi Kodaira, Tokyo, Japan
TEL 042-341-2711
Email ando-t@ncno.go.jp

Public contact
Name of contact person
1st name Tesuya
Middle name
Last name Ando
Organization National Center of Neurology and Psychiatry
Division name Department of Behavioral Medicine, National Institute of Mental Health
Zip code 187-8553
Address 4-1-1 Ogawahigashi Kodaira, Tokyo, Japan
TEL 042-341-2711
Homepage URL
Email ando-t@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center of Neurology and Psychiatry
Address 4-1-1 Ogawahigashi Kodaira, Tokyo, Japan
Tel 042-341-2711
Email ml_rinrijimu@ncnp.go.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
2019 Year 03 Month 29 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 17
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
2016 Year 02 Month 01 Day
Date of IRB
2016 Year 03 Month 16 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2019 Year 08 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
2019 Year 03 Month 28 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041376

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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