UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033872 |
|---|---|
| Receipt number | 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 22:11:52 |
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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
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
crie-tky@umin.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038630
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
