UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041790 |
|---|---|
| Receipt number | R000047702 |
| Scientific Title | Effects of an internet-based interpersonal psychotherapy 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 | 2021/12/16 13:12:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Healthy Interpersonal Communication Training Program
Acronym
HIPCom
Scientific Title
Effects of an internet-based interpersonal psychotherapy intervention for improving psychological well-being among mothers in Japan : a randomized controlled trial
Scientific Title:Acronym
Effects of an internet-based interpersonal psychotherapy 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
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
shimada090@toyo.jp
Sponsor or person
Institute
Toyo University
Institute of Social Sciences
5-28-20, Hakusan, Bunkyo, Tokyo
Institute
Department
Personal name
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
shimada090@toyo.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
400
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 14 | Day |
Last modified on
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047702
