UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033872
Receipt No. R000038630
Scientific Title Examining the effectiveness of a program to facilitate benefit finding among people with mental illness: a randomized controlled superiority trial
Date of disclosure of the study information 2018/08/24
Last modified on 2019/12/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Examining the effectiveness of a program to facilitate benefit finding among people with mental illness: a randomized controlled superiority trial
Acronym Examining the effectiveness of a program to facilitate benefit finding among people with mental illness: a randomized controlled superiority trial
Scientific Title Examining the effectiveness of a program to facilitate benefit finding among people with mental illness: a randomized controlled superiority trial
Scientific Title:Acronym Examining the effectiveness of a program to facilitate benefit finding among people with mental illness: a randomized controlled superiority trial
Region
Japan

Condition
Condition mental illness
Classification by specialty
Psychiatry Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness of the program to facilitate benefit finding among people with mental illness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes benefit finding
(baseline, after the program, and 3 months after the program)
Key secondary outcomes Recovery Assessment Scale
WHO-5
K6
BASIS-32
(baseline, after the program, and 3 months after the program)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group:Participants will undergo the weekly program in eight 1.5-h group sessions. The program includes such as stress management and looking back on one's life with mental illness.
Interventions/Control_2 Control group:Participants will be provided with services as usual.
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 - Diagnosed by a psychiatrist with mental illness
- Aged 20 or older
- Use of services (participation in the activities) at one of the facilities
Key exclusion criteria - Predicted difficulty in the participation of the program due to the schedule
- Severe intellectual disability or dementia
Target sample size 38

Research contact person
Name of lead principal investigator
1st name Rie
Middle name
Last name Chiba
Organization Kobe University
Division name Graduate School of Health Sciences
Zip code 654-0142
Address 7-10-2, Tomogaoka, Suma-ku, Kobe
TEL 078-796-4575
Email crie-tky@umin.ac.jp

Public contact
Name of contact person
1st name Rie
Middle name
Last name Chiba
Organization Kobe University
Division name Graduate School of Health Sciences
Zip code 654-0142
Address 7-10-2, Tomogaoka, Suma-ku, Kobe
TEL 078-796-4575
Homepage URL
Email crie-tky@umin.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Graduate School of Health Sciences, Kobe University
Address 7-10-2, Tomogaoka, Suma-ku, Kobe
Tel 078-796-4502
Email syomu2@ams.kobe-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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 24 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
2018 Year 07 Month 20 Day
Date of IRB
2018 Year 07 Month 09 Day
Anticipated trial start date
2018 Year 08 Month 24 Day
Last follow-up date
2019 Year 07 Month 10 Day
Date of closure to data entry
2019 Year 07 Month 30 Day
Date trial data considered complete
2019 Year 07 Month 30 Day
Date analysis concluded
2019 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 23 Day
Last modified on
2019 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038630

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.