UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031759 |
|---|---|
| Receipt number | 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 | 2019/09/16 09:54:50 |
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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
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
220-shomuhanchou@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kurihama medical and Addiction center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036258
