UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052457 |
|---|---|
| Receipt number | R000058687 |
| Scientific Title | Efficacy and cost-effectiveness of Internet-delivered psychotherapy for irritable bowel syndrome: a randomized controlled trial comparison. |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/11/14 20:21:10 |
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Basic information
Public title
Efficacy and cost-effectiveness of Internet-delivered psychotherapy for irritable bowel syndrome: a randomized controlled trial comparison.
Acronym
ReSET program
Scientific Title
Efficacy and cost-effectiveness of Internet-delivered psychotherapy for irritable bowel syndrome: a randomized controlled trial comparison.
Scientific Title:Acronym
Efficacy and cost-effectiveness of Internet-delivered psychotherapy for irritable bowel syndrome: a randomized controlled trial comparison.
Region
| Japan |
Condition
Condition
irritable bowel syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Internet-based psychotherapy for patients with drug-refractory irritable bowel syndrome
Basic objectives2
Others
Basic objectives -Others
Cost-effectiveness will also be examined.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the IBS Symptom Severity Score
the IBS Quality of Life Measure
Key secondary outcomes
The visceral sensitivity index
The Hospital Anxiety and Depression Scale
EuroQol 5 dimensions 5-level
Work Productivity and Activity Impairment Questionnaire: General Health
Credibility / Expectancy Questionnaire
Irritable Bowel Syndrome-Global Improvement Scale
Customer Satisfaction Scale-3
adverse event or Serious adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Psychotherapy Intervention for Irritable Bowel Syndrome
Interventions/Control_2
Psychotherapy Intervention for Irritable Bowel Syndrome
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Be at least 18 years of age at the time of consent or registration.
(2) Patients must have been diagnosed with IBS at a medical institution by the date of enrollment and have been treated with medication for at least 3 months.
(iii) Patients must have residual symptoms of moderate severity (IBS-SSS over 175 points) or higher at the time of enrollment.
(4) Meet the diagnostic criteria for IBS of Rome IV.
(5) Have regular access to the Internet and be able to participate in online meetings (preferably in an environment that is as quiet and private as possible).
(6) Be able to read, write, and communicate in Japanese
(7) Understand the purpose and content of this study, and be able to give written consent to participate in the study of their own free will.
Key exclusion criteria
(i) At the time of enrolment, those who have received structured psychotherapy for IBS within the last two years, or are receiving it at that time, or plan to receive it during the period of participation.
(ii) At the time of enrolment, are currently participating in another IBS clinical trial, or are scheduled to receive such treatment during the period of participation.
(iii) Those who are currently undergoing psychiatric or psychosomatic treatment and whose attending physician has judged them to be unsuitable for participation in this study.
(iv) Those who are pregnant.
(v) Persons who have undergone or are currently undergoing treatment for organic diseases that may cause symptoms such as abdominal pain.
(vi) Any other person who is judged to be unsuitable as a subject for this study by the principal investigator or research assistant.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | shino |
| Middle name | |
| Last name | kikuchi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Core Laboratory
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL
+81528538545
shino_k@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | shino |
| Middle name | |
| Last name | kikuchi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Core Laboratory
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL
+81528538545
Homepage URL
https://suciri.localinfo.jp/
suciri117@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Centre, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
Tel
+81528587215
irb_jimu@med.nagoya-cu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2023 | Year | 10 | Month | 10 | Day |
Last modified on
| 2024 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058687
