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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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