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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048502
Receipt No. R000055268
Scientific Title A two-session couple intervention for improving couple satisfaction: A feasibility randomized controlled trial (RCT)
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/28

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Basic information
Public title A two-session couple intervention for improving couple satisfaction
Acronym A couple intervention for improving couple satisfaction
Scientific Title A two-session couple intervention for improving couple satisfaction: A feasibility randomized controlled trial (RCT)
Scientific Title:Acronym A feasibility RCT of a couple intervention
Region
Japan

Condition
Condition Couple relationship
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study investigates the feasibility of the two-session couple intervention, both qualitatively and quantitatively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Program safety (qualitative and quantitative), acceptability (qualitative and quantitative), effectiveness ("the couple satisfaction index Japanese version" scores at the post, one month, and three months), and completion rate (quantitative) of the intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Two-session online couple intervention (80 minutes per session)
Interventions/Control_2 Wait list control group
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) Couples who can participate in the study together.
2) Couples who have been cohabiting for at least one year.
3) At least one of the partners has the CSI-4 (i.e., short version of the couple satisfaction index) score of 12 points or less.
4) Couples who can participate in the online interview with PC.
5) Couples who can participate in the study for at least three months continuously.
6) Couples who agree to withdraw from the intervention even after it has begun if the therapist decides that participation is inappropriate for the couple.
7) Couples who agree that the results of each others' responses to the pre-questionnaires can be shared during the intervention sessions.
Key exclusion criteria 1) Couples with psychological or physical violence.
2) Couples with alcohol-related problems
3) Couples in which either or both partners have ongoing infidelity.
4) Couples in either or both partners have a history of receiving medical treatment by a psychiatrist or psychosomatic physician within the past six months.
5) Couples in which one or both partners are currently receiving counselling or psychotherapy.
6) Couples who are about to divorce or separate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Mitamura
Organization Ritsumeikan University
Division name College of comprehensive psychology
Zip code 567-8570
Address 2-150 Iwakura-cho, Ibaraki, Osaka 567-8570 JAPAN
TEL 072-665-2214
Email mitamura-psyc@umin.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Mitamura
Organization Ritsumeikan University
Division name College of comprehensive psychology
Zip code 567-8570
Address 2-150 Iwakura-cho, Ibaraki, Osaka 567-8570 JAPAN
TEL 072-665-2214
Homepage URL
Email mitamura-psyc@umin.ac.jp

Sponsor
Institute College of comprehensive psychology, Ritsumeikan University
Institute
Department

Funding Source
Organization KAKENHI, JSPS
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 Ritsumeikan University Ethics Review Committee for Research Involving Human Subjects (Humanities and Social Sciences)
Address 56-1 Toji-in Kitamachi, Kita-ku, Kyoto, Japan
Tel 075-465-8319
Email k-rinri@st.ritsumei.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
2022 Year 08 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 31 Day
Date of IRB
2022 Year 07 Month 13 Day
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2023 Year 03 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
2022 Year 07 Month 28 Day
Last modified on
2022 Year 07 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055268

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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