UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031836
Receipt number R000036323
Scientific Title Messaging App intervention for gambling problems: a randomized controlled trial
Date of disclosure of the study information 2018/03/23
Last modified on 2020/10/12 06:32:57

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Basic information

Public title

Messaging App intervention for gambling problems: a randomized controlled trial

Acronym

Messaging App intervention for gambling problems: a randomized controlled trial

Scientific Title

Messaging App intervention for gambling problems: a randomized controlled trial

Scientific Title:Acronym

Messaging App intervention for gambling problems: a randomized controlled trial

Region

Japan


Condition

Condition

Problem gambling (We will include gamblers who do not satisfy the diagnostic criteria of DSM-5 for gambling disorder)

Classification by specialty

Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of the message app delivered intervention for problem gambling

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II,III


Assessment

Primary outcomes

Change in PGSI total score from pre- to post-treatment (day 28)

Key secondary outcomes

・GSAS (Gambling Symptom Assessment Scale)
Change through the study period (pre-treatment, day7, 14, 21, 28)
・Amount of money spent on gambling
Change from pre- to post-treatment (day 28)
・Gambling frequency
Change from pre- to post-treatment (day 28)
・Drop-out rate


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

MFS (Monitoring, Feedback, Supportive message)
Personalized Normative Feedback (Message App delivered) for 28 days

Interventions/Control_2

AO (Assessment Only) (Message App delivered) through 28 days

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Inclusion criteria
1. Aged 18 years old or older who uses LINE app
2. Who provides informed consent
3. PGSI (Problem Gambling Severity Index) score of 3 or above at pre-treatment

Key exclusion criteria

(2) Exclusion criteria
1. Who has taken some treatment for their gambling problems at specialized facilities

Target sample size

198


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Susumu Higuchi

Organization

Kurihama Medical and Addiction Center

Division name

Department of Clinical Research

Zip code


Address

Nobi 5-3-1, Yokosuka, Kanagawa Prefecture, Japan

TEL

046-848-1550

Email

gambotamed@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Susumu Higuchi

Organization

Kurihama Medical and Addiction Center

Division name

Department of Clinical Research

Zip code


Address

Nobi 5-3-1, Yokosuka, Kanagawa Prefecture, Japan

TEL

046-848-1550

Homepage URL

http://hachidori.io/hdupload/gambot/index.html

Email

gambotamed@gmail.com


Sponsor or person

Institute

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


Address


Tel


Email



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 23 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

Completed

Date of protocol fixation

2018 Year 03 Month 16 Day

Date of IRB

2018 Year 03 Month 23 Day

Anticipated trial start date

2018 Year 03 Month 26 Day

Last follow-up date

2018 Year 08 Month 31 Day

Date of closure to data entry

2018 Year 09 Month 23 Day

Date trial data considered complete

2018 Year 09 Month 23 Day

Date analysis concluded

2019 Year 04 Month 04 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 22 Day

Last modified on

2020 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036323


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name