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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041790
Receipt No. R000047702
Scientific Title Effects of an internet-based interpersonal psychotherapy (IPT) intervention for improving psychological well-being among mothers in Japan : a randomized controlled trial
Date of disclosure of the study information 2020/09/15
Last modified on 2020/09/14

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Basic information
Public title Healthy Interpersonal Communication Training Program
Acronym HIPCom
Scientific Title Effects of an internet-based interpersonal psychotherapy (IPT) intervention for improving psychological well-being among mothers in Japan : a randomized controlled trial
Scientific Title:Acronym Effects of an internet-based interpersonal psychotherapy (IPT) intervention for improving psychological well-being among mothers in Japan : a randomized controlled trial
Region
Japan

Condition
Condition none
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to examine the effectiveness of a new developed internet based interpersonal psychotherapy program on improving psychological well-being, as primary outcomes, among mothers in Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Psychological well-being [PWBS-J:42 items]
Key secondary outcomes Psychological distress [K6:6 items]
Work engagement [Utrecht Work Engagement Scale [UWES:9 items]
Job and life satisfaction [BJSQ:2 items]
Marital satisfaction [original:1 items]
Happiness[original:1 items]
Strengths and Difficulties Questionnaire[SDQ:25 items]
Big5[TIPI:10 items]
Functional assertiveness scale[12 items]
Communication skills[ENDCORE:6 items]

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 This is an internet learning program that provides interpersonal stress management skills based on IPT (interpersonal psychotherapy) in self-help workbook style. The web based IPT is comprised 4 modules.
Interventions/Control_2 Wait list control condition
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 1)Having a child under 20 years old
2)Age over 20 years old
3)Access to the internet
Key exclusion criteria Not under treatment for psychiatric disorders
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Kyoko
Middle name
Last name Shimada
Organization Toyo University
Division name Institute of Social Sciences
Zip code 1128606
Address 5-28-20, Hakusan, Bunkyo, Tokyo
TEL 03-3945-8539
Email kyoko.shimada927@gmail.com

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name Shimada
Organization Toyo University
Division name Institute of Social Sciences
Zip code 1128606
Address 5-28-20, Hakusan, Bunkyo, Tokyo
TEL 03-3945-8539
Homepage URL
Email kshima-tky@umin.ac.jp

Sponsor
Institute Toyo University
Institute of Social Sciences
5-28-20, Hakusan, Bunkyo, Tokyo
Institute
Department

Funding Source
Organization Ministry of Education
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 Toyo University
Address 112-8606 5-28-20, Hakusan, Bunkyo, Tokyo
Tel 03-3945-8539
Email kshima-tky@umin.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 東洋大学現代社会総合研究所

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 15 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
2020 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 21 Day
Last follow-up date
2021 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 14 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047702

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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