UMIN-CTR Clinical Trial

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
Email	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
Email	m-takesawa@ruri.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040870