UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046672
Receipt number R000053224
Scientific Title A Controlled Comparative Study of Cognitive Assessment for Internet Gaming Disorder (IGD)
Date of disclosure of the study information 2022/02/28
Last modified on 2025/01/21 17:00:36

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Basic information

Public title

A Controlled Comparative Study of Cognitive Assessment for Internet Gaming Disorder (IGD)

Acronym

A Controlled Comparative Study of Cognitive Assessment for Internet Gaming Disorder (IGD)

Scientific Title

A Controlled Comparative Study of Cognitive Assessment for Internet Gaming Disorder (IGD)

Scientific Title:Acronym

A Controlled Comparative Study of Cognitive Assessment for Internet Gaming Disorder (IGD)

Region

Japan


Condition

Condition

Internet Gaming Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A comprehensive assessment of cognitive functioning in Internet gaming disorder will be conducted to accumulate data for diagnosis and treatment.

Basic objectives2

Others

Basic objectives -Others

Relationship to developmental disability and depression

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1.MATRICS-CCB (MATRICS Consensus Cognitive Battery: MATRICS-CCB)
2.Japanese Adult Reading Test, JART
3.Adult ADHD Self-Report Scale-V1.1(ASRS-v1.1)
4.Internet Addiction Score(IAT)
5.The Autism-Spectrum Quotient (AQ)
6.Quick Inventory of Depressive Symptomatology(QIDS)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Psychological tests

Interventions/Control_2


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

16 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who have obtained written consent for this study from the individual and his/her representative.

Key exclusion criteria

1. Those who have requested not to participate in this study based on the published information
2. Those who have an IQ of less than 80 on JART
3. Those who are judged to be incapable of performing the MCCB due to eye or hearing disease.
4. Patients who are judged to be inappropriate by the investigators.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Ikuo
Middle name
Last name Otsuka

Organization

Kobe University Hospital

Division name

psychiatry

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe City,Hyogo Prefecture

TEL

078-382-6065

Email

otsuka19@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Haruka
Middle name
Last name Minami

Organization

Kobe University Hospital

Division name

psychiatry

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe City,Hyogo Prefecture

TEL

078-382-6065

Homepage URL


Email

minamih@med.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kobe University Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe University Hospital

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe City,Hyogo Prefecture

Tel

078-382-6065

Email

kainyu@med.kobe-u.ac.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

神戸大学医学部附属病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2022 Year 02 Month 28 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

No longer recruiting

Date of protocol fixation

2022 Year 01 Month 25 Day

Date of IRB

2022 Year 07 Month 20 Day

Anticipated trial start date

2022 Year 02 Month 28 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 01 Month 19 Day

Last modified on

2025 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053224