UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044761 |
|---|---|
| Receipt number | R000051121 |
| Scientific Title | Randomized control trial to examine the effect of cognitive behavior therapy using smartphone in patients with recurrent pregnancy loss |
| Date of disclosure of the study information | 2021/07/05 |
| Last modified on | 2021/07/05 16:14:05 |
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Basic information
Public title
Randomized control trial to examine the effect of cognitive behavior therapy using smartphone in patients with recurrent pregnancy loss
Acronym
MONALISA study
Scientific Title
Randomized control trial to examine the effect of cognitive behavior therapy using smartphone in patients with recurrent pregnancy loss
Scientific Title:Acronym
MONALISA study
Region
| Japan |
Condition
Condition
Recurrent pregnancy loss
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of cognitive behavior therapy using smartphone on the improvement of depression or anxiety in patients with recurrent pregnancy loss.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The improvement of depression
Key secondary outcomes
The improvement of live birth rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Randomize 5 methods of self-monitoring, Cognitive Restructuring, Behavioral Activation, Assertion Training, Problem Solving
Interventions/Control_2
Patients who try none of 5 kinds of cognitive behavior therapies are controls
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
two or more pregnancy losses
have a smartphone
Key exclusion criteria
severe disease or mental disorder
women who can not use smartphone
women who wish for suicide
women who can not understand Japanese
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Sugiura |
Organization
Nagoya City University
Division name
Obstetrics and Gynecology
Zip code
467-8601
Address
Kawasumi-1, Mizuho-ku, Nagoya
TEL
0528515511
og.mym@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Sakura |
| Middle name | |
| Last name | Ogasawara |
Organization
Nagoya City University
Division name
Obstetrics and Gynecology
Zip code
467-8601
Address
Kawasumi-1, Mizuho-ku, Nagoya
TEL
0528515511
Homepage URL
o.sakura0308@gmail.com
Sponsor or person
Institute
Nagoya City university
Institute
Department
Personal name
Funding Source
Organization
The Japanese Ministry of Education, Science, and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
Kawasumi-1, Mizuho-ku, Nagoya
Tel
0528587215
clinical_research@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
名古屋市立大学病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2021 | Year | 07 | Month | 05 | Day |
Last modified on
| 2021 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051121
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
