UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	o.sakura0308@gmail.com

Sponsor
Institute	Nagoya City university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051121