UMIN-ICDS Clinical Trial

Public title

A Study on Contextual Couples therapy for improving couple relationship

Acronym

Contextual Couples therapy for improving couple relationship

Scientific Title

A Study on the Effects and Process of Change in Contextual Couple Therapy (CCT)

Scientific Title:Acronym

The Effects and Process of Change in Contextual Couple Therapy (CCT)

Region

Japan

Condition

Couple relationship

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the efficacy of contextual couples therapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

the Japanese version of the Perceived Responsiveness and Insensitivity Scale (PRIS-J)

Key secondary outcomes

1) the couple satisfaction index Japanese version (CSI-J)
2) the Japanese version of the Experience in Close Relationship- Relationship Structure (ECR-RS)
3) the Japanese version Patient Health Questionnaire-9 (PHQ-9)
4) the Japanese version of Coparenting Relationship Scale (CRS-J)
5) current relationship status

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

80-minute online couples therapy sessions

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Couples who wish to improve their relationship.
2) Couples who are able to participate in the study together, secure a time and place where they can focus on the sessions, and coordinate their schedules with the researcher or therapist.
3) Couples who have been cohabiting for at least one year.
4) Couples who are able to participate in online sessions using a computer.
5) Couples who agree that they may need to provide repeated responses to survey questions, and that the intervention sessions may be postponed if at least one partner fails to respond for four or more consecutive days.
6) Couples who agree that the results of each others' responses to the pre-questionnaires can be shared during the intervention sessions.
7) In the results of the first questionnaire survey, at least one of the partners has the PPR-8 (i.e., 8-item version of Partner Perceived Responsiveness Scale) score of 18 points or less.

Key exclusion criteria

1) Couples with psychological or physical violence.
2) Couples with self-harm or related behaviors.
3) Couples with alcohol-related problems.
4) Couples in which either or both partners have ongoing infidelity.
5) Couples in either or both partners have a history of receiving medical treatment by a psychiatrist or psychosomatic physician within the past six months.

Target sample size

40

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

Name of contact person

1st name	Chisato
Middle name
Last name	Tani

Organization

Ritsumeikan University

Division name

College of comprehensive psychology

Zip code

567-8570

Address

2-150 Iwakura-cho, Ibaraki, Osaka 567-8570 JAPAN

TEL

072-665-2490

Homepage URL

Email

tani-psyc@umin.ac.jp

Institute

Ritsumeikan University

Institute

Department

Personal name

Organization

KAKENHI, JSPS

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

075-813-8199

Email

k-rinri@st.ritsumei.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

06

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

03

Month

20

Day

Date of IRB

2026

Year

06

Month

10

Day

Anticipated trial start date

2026

Year

06

Month

15

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

06

Month

11

Day

Last modified on

2026

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070798