UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011436 |
|---|---|
| Receipt number | 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 16:12:45 |
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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
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
Sponsor or person
Institute
Graduate School of Life and Environment Sciences, Kyoto Prefectural University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013389
