UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035874 |
|---|---|
| Receipt number | R000040870 |
| Scientific Title | Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement |
| Date of disclosure of the study information | 2019/02/28 |
| Last modified on | 2021/08/28 13:31:04 |
* 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
Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Acronym
Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Scientific Title
Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Scientific Title:Acronym
Effect of Cognitive Behavior Therapy Program that aims to modification of attentional bias on Drinking Behavior Improvement
Region
| Japan |
Condition
Condition
Alcohol use disorders
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of whether to contributes to reduction of impulsive drinking behavior by implementing cognitive behavioral therapy with attention bias correction training for patients with impaired alcohol use
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms of Addiction
(The Alcohol Use Disorders Identification Test)
Alcohol Relapse Risk Scale
Degree of inhibition of reaction to alcohol(stop-signal task)
Key secondary outcomes
Environmental Reward Observation Scale
Acceptance and Action Questionnaire-II
Mindful Attention Awareness Scale
GHQ28
Attentional bias
(visual probe task)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
For the experimental group, we will perform a carefulness correction exercise in 6 sessions (about 20 minutes) out of all 8 programs.
Interventions/Control_2
For the control group, we will perform a carefulness correction exercise in 6 sessions (about 20 minutes) out of all 8 programs.
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
(1)
Oishi clinicPerson in hospital
(2)
Alcohol use disorders
(3)
At the time of the agreement acquisition; a person 20 years or older
(4)
The person that an agreement of study entry was provided from the person after a procedure of the informed consent
Key exclusion criteria
(1)
The person who it was judged the chief physician to have difficulty in participation in this study
(2)
The person who feels extreme sleep
shortage or fatigue at the time of
study enforcement
(3)
The person who experiences
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | SHIMADA |
Organization
Waseda University
Division name
Faculty of Human Science
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL
+81-4-2949-8113
simac@waseda.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | TAKESAWA |
Organization
Waseda University
Division name
Graduate School of Human Science
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL
+81-4-2949-8113
Homepage URL
m-takesawa@ruri.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Tobacco Academic Studies Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
Tel
+81-4-2949-8113
rinri@list.waseda.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
医療法人社団祐和会大石クリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.tasc.or.jp/assist/archives/2019/pdf/2020_05B.pdf
Number of participants that the trial has enrolled
7
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
| 2019 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 02 | Month | 14 | Day |
Last modified on
| 2021 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040870
