UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of Group Cognitive Behavioural Therapy for pathological internet use
Title of the study (Brief title)	The effectiveness of Group Cognitive Behavioural Therapy for pathological internet use
Region	Africa

Condition
Condition	Pathological internet usage
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of group cognitive-behavioural therapy on pathological internet use among students in Federal Colleges of Education in South-East, Nigeria.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Problematic Internet Use Scale (PIUS): Time 1, Time 2, Time 3
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Treatment group (n=20) Group Cognitive Behavioural Therapy Manual (GCBT Manual): 8 weeks One session per Week
Interventions/Control_2	Waitlist control group (n=20)
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Diagnostic Statistical Manual of Mental Disorders (DSM-V) and International Classification of Diseases (ICD-11) criteria on classification of disorders
Key exclusion criteria	Not meeting the inclusion criteria
Target sample size	40

Research contact person
Name of lead principal investigator	Moses Onyemaechi Ede
Organization	University of Nigeria, Nsukka
Division name	Department of Educational Foundations
Address	Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
TEL	+2347066725165
Email	moses.ede@unn.edu.ng

Public contact
Name of contact person	Moses Onyemaechi Ede
Organization	University of Nigeria, Nsukka
Division name	Department of Educational Foundations
Address	Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Educatio
TEL	+2347066725165
Homepage URL
Email	moses.ede@unn.edu.ng

Sponsor
Institute	Otusum Consult Nigeria
Institute
Department

Funding Source
Organization	University of Nigeria, Nsukka
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 12 Day
Anticipated trial start date	2018 Year 03 Month 15 Day
Last follow-up date	2018 Year 06 Month 08 Day
Date of closure to data entry	2018 Year 09 Month 21 Day
Date trial data considered complete	2018 Year 10 Month 18 Day
Date analysis concluded	2018 Year 11 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 22 Day
Last modified on	2018 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040270