UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034245 |
|---|---|
| Receipt number | R000038993 |
| Scientific Title | Behavioral activation-based program at local residents' meeting on their well-being (MInami-seikyo behavioural Activation On Well-being: MIAOW study): a cluster randomized controlled trial |
| Date of disclosure of the study information | 2018/09/25 |
| Last modified on | 2018/09/23 21:29:05 |
* 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
Behavioral activation-based program at local residents' meeting on their well-being (MInami-seikyo behavioural Activation On Well-being: MIAOW study): a cluster randomized controlled trial
Acronym
MIAOW study
Scientific Title
Behavioral activation-based program at local residents' meeting on their well-being (MInami-seikyo behavioural Activation On Well-being: MIAOW study): a cluster randomized controlled trial
Scientific Title:Acronym
MIAOW study
Region
| Japan |
Condition
Condition
well-being
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether a cognitive behavioral therapy/behavioral activation-based program at a tea/coffee meeting of local residents improve their well-being
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
WHO-5 one week after the behavioral activation program
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
one hour of cognitive behavioral therapy/behavioral activation-based group program
Interventions/Control_2
one hour lecture on fraility
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
Able to give informed consent on their own
WHO-5 20 or less at the baseline assessment
Key exclusion criteria
WHO-5 more than 20 at the baseline assessment
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanda Shigeru |
Organization
Minami Seikyo Hospital
Division name
Medical Office
Zip code
Address
2-204, Minami-Odaka, Midori-ku, Nagoya, Aichi 459-8540, Japan
TEL
052-625-0373
ikyoku-jimukyoku2@minami.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Furukawa Yuki |
Organization
Minami Seikyo Hospital
Division name
Medical Office
Zip code
Address
2-204, Minami-Odaka, Midori-ku, Nagoya, Aichi 459-8540, Japan
TEL
052-625-0373
Homepage URL
ikyoku-jimukyoku2@minami.or.jp
Sponsor or person
Institute
Minami Seikyo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 09 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 23 | Day |
Last modified on
| 2018 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038993
