UMIN-CTR Clinical Trial

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	Main results already published
Date of protocol fixation	2017 Year 12 Month 22 Day
Date of IRB	2017 Year 12 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 08 Day
Last follow-up date	2019 Year 05 Month 30 Day
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 09 Month 16 Day

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