UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033631 |
|---|---|
| Receipt number | R000038295 |
| Scientific Title | Effects of Cognitive Behavioral Self-monitoring app on Reducing Problem Drinking among Japanese Adults |
| Date of disclosure of the study information | 2018/08/06 |
| Last modified on | 2021/09/29 16:22:42 |
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Basic information
Public title
Effects of Cognitive Behavioral Self-monitoring app on Reducing Problem Drinking among Japanese Adults
Acronym
Effects of Self-monitoring App on Problem Drinking
Scientific Title
Effects of Cognitive Behavioral Self-monitoring app on Reducing Problem Drinking among Japanese Adults
Scientific Title:Acronym
Effects of Self-monitoring App on Problem Drinking
Region
| Japan |
Condition
Condition
Alcohol use disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to reduce excessive drinking, depression and anxiety by using in a self-monitoring app for one month.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Drinking quantity
Drinking frequency
Key secondary outcomes
Alcohol outcome expectancies
Self-monitoring tendency
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Assessment only
Interventions/Control_2
App use only
Interventions/Control_3
App use plus professional's feedback
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
AUDIT score of 8 or higher
Key exclusion criteria
AUDIT score 7 or lower
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Shimoyama |
Organization
Graduate School of Education, the University of Tokyo
Division name
Division of Clinical Psychology
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
81-3-5841-3904
h3954s@p.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Toshitaka |
| Middle name | |
| Last name | Hamamura |
Organization
Graduate School of Education, the University of Tokyo
Division name
Division of Clinical Psychology
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
81-3-5841-3904
Homepage URL
toshitaka.hamamura@gmail.com
Sponsor or person
Institute
Graduate School of Education, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Social ICT Global Creative Leader Program, the University of Tokyo
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
Life Science Research Ethics and Safety
Address
113-8654 7-3-1 Hongo Bunkyo-ku, Tokyo
Tel
03-5841-0643
lifescience.adm@gs.mail.u-tokyo.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 | 06 | Day |
Related information
URL releasing protocol
https://www.researchprotocols.org/2018/5/e10650/
Publication of results
Published
Result
URL related to results and publications
https://osf.io/564rf/
Number of participants that the trial has enrolled
546
Results
The attrition rates at each follow-up were 52.93%, 49.45%, and 32.60%, respectively. The time x condition interaction effect on weekly drinking quantity was significant at the two- and six-month follow-ups, d = 0.28, 95% CI [0.04, 0.51], d = 0.34, 95% CI [0.06, 0.64], respectively. Moderations related to the intervention effect were not statistically significant.
Results date posted
| 2021 | Year | 09 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age was 20 years old or older, and the AUDIT score was 8 or higher.
Participant flow
Participants were asked to complete the outcome measures at four points: at baseline and at one-, two-, and six-month follow-ups. At each evaluation, participants were asked to enter self-assessed information about their drinking patterns since their last participation. If participants missed a follow-up, they were still invited to complete the subsequent follow-up measures. At the end of the trial, participants were debriefed about the nature of the study. After completion of all follow-ups, participants received 1200 yen in remuneration through the recruitment websites: 800 yen at 2-month follow-up and 400 yen at 6-month follow-up (roughly US 10 US dolloars in total on June 1, 2018).
Adverse events
None reported
Outcome measures
Weekly drinking quantity and abstinent days, largest drinking quantity in one day, and alcohol-related consequences
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 03 | Day |
Last modified on
| 2021 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038295
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