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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040530
Receipt No. R000046236
Scientific Title Modification of Attention Bias in Alcohol Use Disorders Suppresses relapse: An Intervention Study
Date of disclosure of the study information 2020/07/01
Last modified on 2020/05/26

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Basic information
Public title Effects of interventions combining attentional bias modification and cognitive behavior therapy on the risk of re-drinking or relapse in patients with alcohol use disorders
Acronym An interventional study of attentional bias modification in patients with alcohol use disorders
Scientific Title Modification of Attention Bias in Alcohol Use Disorders Suppresses relapse: An Intervention Study
Scientific Title:Acronym An interventional study of attentional bias modification in patients with alcohol use disorders
Region
Japan

Condition
Condition Alcohol use disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of the effect of intervention combined with correction training of attention bias and cognitive behavioral therapy on reduction of re-drinking risk for people with alcohol use disorders
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Alcohol Relapse Risk Scale
Key secondary outcomes Behavioral inhibition system/behavioral approach system scales
Attention bias measurement
Low Frequency/High Frequency
Amount of saliva
Profile of Mood States 2nd Edition

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
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 6 programs
Interventions/Control_2 For the control group, we will perform a placebo carefulness correction exercise in 6 sessions (about 20 minutes) out of all 6 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
60 years-old >=
Gender Male
Key inclusion criteria (1) Persons admitted to Tokyo Alcohol Medical Center, Narimasu Welfare Hospital and diagnosed with alcoholism.
(2) Those who have cognitive function and can obtain the consent of the research.
(3) Those who have passed the withdrawal period and are judged to be able to intervene by the attending physician.
Key exclusion criteria (1) Those with mental disorders other than alcoholic disorders
(2) Those who are scheduled to be discharged within 2 months
(3) Those who have been transferred from another hospital
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Amano
Middle name
Last name Yoshifumi
Organization Graduate School of Saitama Prefectural University
Division name Doctoral Course
Zip code 3438540
Address 820 Sannomiya, Koshigaya City, Saitama Prefecture
TEL 0489710500
Email 2091002e@spu.ac.jp

Public contact
Name of contact person
1st name Amano
Middle name
Last name Yoshifumi
Organization Narimasu welfare hospital
Division name Occupational therapy division
Zip code 1750091
Address 1-19-1, Misono, Itabashi-ku, Tokyo
TEL 03-3939-1191
Homepage URL
Email 2091002e@spu.ac.jp

Sponsor
Institute Graduate School of Saitama Prefectural University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Prefectural University Graduate School Ethics Committee
Address 820 Sannomiya, Koshigaya City, Saitama Prefecture
Tel 0489710500
Email rinri@spu.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
2020 Year 07 Month 01 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
2020 Year 07 Month 01 Day
Date of IRB
2017 Year 07 Month 01 Day
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2022 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 26 Day
Last modified on
2020 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046236

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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