UMIN-CTR Clinical Trial

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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