UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041743
Receipt number R000045041
Scientific Title Development and evaluation of a peer-led learning program about romantic relationships and marriage of persons with mental disorders
Date of disclosure of the study information 2020/09/09
Last modified on 2023/01/21 20:50:31

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Basic information

Public title

Development and evaluation of a peer-led learning program about romantic relationships and marriage of persons with mental disorders

Acronym

Peer-led learning program about romantic relationships and marriage

Scientific Title

Development and evaluation of a peer-led learning program about romantic relationships and marriage of persons with mental disorders

Scientific Title:Acronym

Peer-led learning program about romantic relationships and marriage

Region

Japan


Condition

Condition

mental disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this intervention is to develop a peer-learning program on the theme of romantic relationships and marriage for people with mental disorders and evaluate its effectiveness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Self-esteem scale

Key secondary outcomes

Recovery Assessment Scale, Hope Herth Index, etc


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

The intervention period is 2 days
For the intervention group, perform a questionnaire-based outcome evaluation before, immediately after, and one month later.
In the intervention group, conduct an interview survey one month later after answering the questionnaire and evaluate the intervention process.
1 group 2-3 facilitators, up to 10 people in total including participants
I carry out 60 minutes four times once in two days
Use text (A5 size, about 60 pages)

Interventions/Control_2


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

Male and Female

Key inclusion criteria

Adults (aged 20 and over) who meet all of the following
1. Outpatient receiving a diagnosis of mental illness
Mental illnesses include schizophrenia, depression, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, panic disorder, dissociative disorder, eating disorder, and developmental disorder.
2. It is judged that the mental symptoms are stable enough to allow the attending psychiatrist to participate in this study
3. The psychiatrist of mental illness judges that participation in this study is not expected to hinder psychiatric treatment
4. Communicate well, understand research explanations well, and judge research cooperation by themselves
5. Participate in group discussions using Japanese without difficulty

Key exclusion criteria

non

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Masako
Middle name
Last name Kageyama

Organization

Osaka University Graduate School of Medicine

Division name

Division of Health Sciences

Zip code

565-0871

Address

Yamadaoka 1-7, Suita, Osaka

TEL

06-6879-2553

Email

kageyama@sahs.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Masako
Middle name
Last name Kageyama

Organization

Osaka University Graduate School of Medicine

Division name

Division of Health Sciences

Zip code

565-0871

Address

Yamadaoka 1-7, Suita, Osaka

TEL

06-6879-2553

Homepage URL


Email

kageyama@sahs.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

KAKENHI

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Review Board Osaka University Hospital

Address

Yamadaoka 2-2, Suita, Osaka, Japan, 565-0871

Tel

06-6210-8289

Email

rinri@hp-crc.med.osaka-u.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

横浜など


Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 09 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

54

Results

An interim analysis was performed when this program was implemented for 9 people.The nine people used in the interim analysis will not be included in the subsequent analysis subjects.
Entries were accepted up to a group of over 40 participants, 45 of whom participated. Significant effects were confirmed in self-esteem, Herth Hope Index, and communication up to one month later.

Results date posted

2021 Year 04 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Of the 45 participants, 26 were men and 19 were women. The average age of the participants was 40 years. The main disorders were schizophrenia in 16 participants, developmental disorders in 14, mood disorders in 11, and neurotic disorders in 4.

Participant flow

64 applied, 19 were excluded (including 4 exclusion criteria), 45 participated in the program; 3 dropped out, 42 stayed through the program to the end and completed the evaluation.

Adverse events

Nothing

Outcome measures

Recovery Assessment Scale (RAS), Rosenberg's Self-Esteem Scale (RSES), Herth Hope Index (HHI), and 11 independently developed items.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 04 Month 09 Day

Date of IRB

2020 Year 04 Month 14 Day

Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2022 Year 12 Month 25 Day

Date of closure to data entry

2023 Year 01 Month 10 Day

Date trial data considered complete

2023 Year 01 Month 10 Day

Date analysis concluded

2023 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 09 Month 09 Day

Last modified on

2023 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045041


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name