UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048502 |
|---|---|
| Receipt number | 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 | 2023/07/29 10:43:33 |
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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
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
mitamura-psyc@umin.ac.jp
Sponsor or person
Institute
College of comprehensive psychology, Ritsumeikan University
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055268
