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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031759
Receipt No. R000036258
Scientific Title Development of a standardized cognitive behavioral therapy (CBT) based outpatient treatment program for gambling disorder, and a multi-center randomized controlled trial (RCT) to evaluate the efficacy of the program.
Date of disclosure of the study information 2018/03/19
Last modified on 2019/03/29

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Basic information
Public title Development of a standardized cognitive behavioral therapy (CBT) based outpatient treatment program for gambling disorder, and a multi-center randomized controlled trial (RCT) to evaluate the efficacy of the program.
Acronym Development of a standardized CBT-based treatment program for gambling disorder and an RCT to evaluate its efficacy.
Scientific Title Development of a standardized cognitive behavioral therapy (CBT) based outpatient treatment program for gambling disorder, and a multi-center randomized controlled trial (RCT) to evaluate the efficacy of the program.
Scientific Title:Acronym Development of a standardized CBT-based treatment program for gambling disorder and an RCT to evaluate its efficacy.
Region
Japan

Condition
Condition Gambling Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To develop a standardized cognitive behavioral therapy (CBT) based outpatient treatment program for gambling disorder.
2) To evaluate the efficacy of the program using a randomized controlled trial with the participation of multiple treatment centers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The number and frequency of gambling incidents by study participants in the six-month period following the implementation of the treatment program.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 We conduct one CBT session to subjects every two weeks. Frequency of CBT is six in total. We provide CBT to less than or equal to ten people. We set one CBT session in longer than sixty minutes.
Interventions/Control_2 Waiting
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who are diagnosed as having gambling disorder, based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
Key exclusion criteria 1) Subjects who cannot be diagnosed as having gambling disorder
2) Those who have received treatment for gambling disorder
3) Those who have mental retardation, dementing disorders, schizophrenia, bipolar disorder, or substance dependence
4) Those who are unable to conduct a treatment program
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Susumu
Middle name
Last name Higuchi
Organization National Hospital Organization Kurihama medical and Addiction center
Division name Mental health division
Zip code 2390841
Address 5-3-1, Nobi, Yokosuka city, kanagawa prefecture, Japan
TEL 046-848-1550
Email h-susumu@db3.so-net.ne.jp

Public contact
Name of contact person
1st name Tatsuro
Middle name
Last name Okawa
Organization National Hospital Organization Kurihama medical and Addiction center
Division name General Affairs Department
Zip code 2390841
Address 5-3-1, Nobi, Yokosuka city, kanagawa prefecture, Japan
TEL 046-848-1550
Homepage URL
Email 220-shomuhanchou@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Kurihama medical and Addiction center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 National Hospital Organization Kurihama medical and Addiction center
Address 5-3-1, Nobi, Yokosuka city, kanagawa prefecture, Japan
Tel 046-848-1550
Email 220-shomuhanchou@mail.hosp.go.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 03 Month 19 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 16 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036258

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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