UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054662 |
|---|---|
| Receipt number | R000062464 |
| Scientific Title | The exploration of strategies to enhance the utilization of activity chart |
| Date of disclosure of the study information | 2024/06/15 |
| Last modified on | 2025/01/20 14:10:19 |
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Basic information
Public title
The exploration of strategies to enhance the utilization of activity chart
Acronym
The exploration of strategies to enhance the utilization of activity chart
Scientific Title
The exploration of strategies to enhance the utilization of activity chart
Scientific Title:Acronym
The exploration of strategies to enhance the utilization of activity chart
Region
| Japan |
Condition
Condition
Major Depressive disorder
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the effects of various methods on promoting the self-help efforts of participants in psychotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Frequency of activity log sheet completion during the one-month intervention period
Key secondary outcomes
Change in questionnaire scores before and after the one-month intervention period
K10
SRS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Social Reward Group
The social reward will consist of a praise message sent every two days by the research implementer, acknowledging the efforts made by participants throughout the month. The content of each message will specifically praise the initiatives reported by the participants.
Interventions/Control_2
Reward Group
Information shall be presented on the increase in remuneration according to the amount of efforts made during a month. If the average number of times a person uses the service more than once a day, the reward is increased by 2,000 yen; if the average number of times a person uses the service less than once a day but more than 0.75 times a day, the reward is increased by 1,000 yen; if the average number of times a person uses the service less than 0.75 times a day but more than 0.5 times a day, the reward is increased by 500 yen; and if the average number of times a person uses the service less than once a day, the basic reward (1,000 yen) is offered. In the case of less than that, the basic remuneration (1,000 yen) will be paid.
Interventions/Control_3
Social Declaration Group
Participants in the Social Declaration Group will anonymously declare the amount of work they plan to undertake each week. This process allows participants to continuously monitor both their own declarations and those of others on a dedicated website.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healty adults
Ability to communicate in Japanese as necessary to explain interventions, etc.
Possession of a smartphone for personal use
Key exclusion criteria
Individuals undergoing psychiatric or psychosomatic treatment
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | ITO |
Organization
Fukushima University
Division name
Faculty of Human Development and Culture
Zip code
9601296
Address
1, Kanayagawa, Fukushima-city, Fukushima
TEL
024-548-8103
masa-ito@educ.fukushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | ITO |
Organization
Fukushima University
Division name
Faculty of Human Development and Culture
Zip code
9601296
Address
1, Kanayagawa, Fukushima-city, Fukushima
TEL
024-548-8103
Homepage URL
masa-ito@educ.fukushima-u.ac.jp
Sponsor or person
Institute
Fukushima University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Fukushima University
Address
1, Kanayagawa, Fukushima-city, Fukushima
Tel
024-548-8009
kyoudo@adb.fukushima-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
| 2024 | Year | 06 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062464
