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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011436
Receipt No. R000013389
Scientific Title A randomized controlled trial of cognitive behavioral therapy-based self-monitoring for irritable bowel syndrome in female nursing school students
Date of disclosure of the study information 2013/08/09
Last modified on 2013/08/09

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Basic information
Public title A randomized controlled trial of cognitive behavioral therapy-based self-monitoring for irritable bowel syndrome in female nursing school students
Acronym Self-monitoring for irritable bowel syndrome
Scientific Title A randomized controlled trial of cognitive behavioral therapy-based self-monitoring for irritable bowel syndrome in female nursing school students
Scientific Title:Acronym Self-monitoring for irritable bowel syndrome
Region
Japan

Condition
Condition Irritable bowel syndrome (IBS)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to verify the efficacy of CBT for the improvement of the IBS, based on lifestyle self-monitoring intervention, and reveal what changed, especially for anxiety and depression, due to the intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome measures were Rome II criteria for IBS, the Hospital Anxiety and Depression Scale (HADS) and the Gastrointestinal Symptom Rating Scale (GSRS), assessed at the baseline and the end of both of the intervention periods.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The intervention groups conducted lifestyle self-monitoring in conjunction with a 15-minutes group work for two months.
Interventions/Control_2 The intervention groups conducted lifestyle self-monitoring in conjunction with a 15-minutes group work for four months.
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
26 years-old >=
Gender Female
Key inclusion criteria females
no diagnosis of inflammatory bowel diseases
data inadequacy
Key exclusion criteria males
diagnosis of inflammatory bowel diseases
no data inadequacy
Target sample size 103

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukiko Okami
Organization Nagoya Bunri University
Division name Department of Health and Nutrition
Zip code
Address 365, Maeda, Inazawa-cho, Inazawa city, Aichi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Kyoto Prefectural University
Division name Life and Environment Sciences
Zip code
Address 1-5, Hangi-cho, Shimogamo, Sakyo-ku, Kyoto
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Life and Environment Sciences, Kyoto Prefectural University
Institute
Department

Funding Source
Organization Graduate School of Life and Environment Sciences, Kyoto Prefectural University
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
Address
Tel
Email

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
2013 Year 08 Month 09 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 Completed
Date of protocol fixation
2009 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2009 Year 10 Month 15 Day
Date of closure to data entry
2009 Year 12 Month 15 Day
Date trial data considered complete
2009 Year 12 Month 31 Day
Date analysis concluded
2010 Year 01 Month 20 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 09 Day
Last modified on
2013 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013389

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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