UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051905 |
|---|---|
| Receipt number | R000057614 |
| Scientific Title | Before-and-After Comparative Study Using Smartphone of Self-Guided Mental Health Care Content which Based on SAT Counseling Techniques for Behavior Change towards Alcohol Dependence. |
| Date of disclosure of the study information | 2023/08/16 |
| Last modified on | 2023/08/14 18:51:07 |
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Basic information
Public title
Analysis the Effectiveness of SAT Counseling Techniques for Behavior Change towards Alcohol Dependence utilize Self-Mental Health Care Content through a Smartphone.
Acronym
Analysis the Effectiveness of SAT Counseling Techniques for Behavior Change towards Alcohol Dependence utilize Self-Mental Health Care Content through a Smartphone.
Scientific Title
Before-and-After Comparative Study Using Smartphone of Self-Guided Mental Health Care Content which Based on SAT Counseling Techniques for Behavior Change towards Alcohol Dependence.
Scientific Title:Acronym
Before-and-After Comparative Study Using Smartphone of Self-Guided Mental Health Care Content for Behavior Change towards Alcohol Dependence.
Region
| Japan |
Condition
Condition
alcohol dependence
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effectiveness of self-mental health care content for smartphones based on SAT counseling techniques as a behavior change program in Alcohol Dependence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Data Collections are;
1.Before the program start
2.Two weeks after the program
3.End of the program
Measurements: Post-Acute Withdrawal Symptoms of Alcohol Dependence
Key secondary outcomes
Data Collections are;
1.Before the program start
2.Two weeks after the program
3.End of the program
Measurements:
State-Trait Anxiety Inventory
Self-rating Depression Scale
Self-repression behavioral trait
Emotional support network
Problem solving behavioral trait
Emotional Interpersonal dependency inventory
Heart Rate
Blood Pressure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
self-mental health care content for smartphones based on SAT counseling techniques as a behavior change program in Alcohol Dependence.
Interventions/Control_2
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
Alcohol Dependency patients who received alcoholism treatment and sober alcohol less than four years.
Key exclusion criteria
Not sober
Have another mental illness other than Alcohol Dependence
Cannot use a smart phone
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Ito |
Organization
Toho University
Division name
Faculty of Nursing
Zip code
143-0015
Address
4-16-20, Omori-Nishi Ota-ku, Tokyo
TEL
+81-3-3762-9881
keiko.itou@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Ito |
Organization
Toho University
Division name
Faculty of Nursing
Zip code
143-0015
Address
4-16-20, Omori-Nishi Ota-ku, Tokyo
TEL
+81-3-3762-9881
Homepage URL
keiko.itou@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Keiko Ito
Funding Source
Organization
Japan Science and Technology Agency
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
Toho University
Address
4-16-20, Omori-Nishi Ota-ku, Tokyo
Tel
+81-3-3762-9881
keiko.itou@med.toho-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
| 2023 | Year | 08 | Month | 16 | 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
| 2022 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 08 | Month | 14 | Day |
Last modified on
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057614
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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