NCT04257890

Brief Summary

This RCT study develops a brief group-based CBT intervention. The primary objective is to evaluate the efficacy of the CBT in reducing IGD, compare to a wait-list control group.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
2 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

December 27, 2019

Last Update Submit

July 29, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline Internet gaming disorder (IGD) immediately after the interventions

    The DSM-5 classification of IGD: The 9-item IGD checklist is a short, user-friendly, self-report measure for assessing the DSM-5 classification of IGD. Symptoms to be assessed include preoccupation, tolerance, withdrawal, unsuccessful attempts to limit gaming, deception or lies about gaming, loss of interest in other activities, use despite knowledge of harm, use for escape or relief of negative mood, and harm in the past 12 months. Response options are no (0) and yes (1). As per the DSM-5 recommendation, those with \>=5 'yes' responses are considered IGD cases. The Chinese version has been validated with high internal consistency.

    immediately after the interventions

  • Change from baseline Internet gaming disorder (IGD) at 6 months

    The DSM-5 classification of IGD: The 9-item IGD checklist is a short, user-friendly, self-report measure for assessing the DSM-5 classification of IGD. Symptoms to be assessed include preoccupation, tolerance, withdrawal, unsuccessful attempts to limit gaming, deception or lies about gaming, loss of interest in other activities, use despite knowledge of harm, use for escape or relief of negative mood, and harm in the past 12 months. Response options are no (0) and yes (1). As per the DSM-5 recommendation, those with \>=5 'yes' responses are considered IGD cases. The Chinese version has been validated with high internal consistency.

    six months after the interventions

Study Arms (2)

CBT intervention group

EXPERIMENTAL

In addition to the information about IGD of the control group, the intervention group will receive eight weekly group-based 90-minute CBT sessions.

Behavioral: Cognitive behavioral therapyOther: Education material about IGDOther: Education material about CBT

Wait-list control group

ACTIVE COMPARATOR

Members will receive printed education material about IGD but not CBT during the treatment period.

Behavioral: Cognitive behavioral therapyOther: Education material about IGDOther: Education material about CBT

Interventions

The CBT focuses on cognitive restructuring to reduce the specific key maladaptive beliefs on Internet gaming suggested by King's model, and develop useful coping skills (self-regulation/control, emotion regulation, problem-solving coping) that are adapted from previous CBT for adolescent IGD. In addition, it provides training on relapse-prevention and maintenance techniques.

CBT intervention groupWait-list control group

Printed education material introducing IGD will be distributed.

CBT intervention groupWait-list control group

Printed education material introducing CBT will be distributed.

CBT intervention groupWait-list control group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • secondary 1-4 students (grade 7-10),
  • positive screening results (i.e. IGD cases) according to a validated questionnaire (the 5 DSM-5 criteria for IGD),
  • students' and parental consent,
  • Chinese speaking.

You may not qualify if:

  • self-reported history of any psychiatric or neurological illness,
  • current use of any psychotropic medication.
  • We do not include Secondary 5-6 students due to their preparation for public examinations and practical difficulty in follow-up after their graduation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

HKMLC Queen Maud Secondary School

Hong Kong, Hong Kong, China

ACTIVE NOT RECRUITING

Henrietta Secondary School

Hong Kong, Hong Kong

RECRUITING

Po Kok Secondary School

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

Po Leung Kuk Lee Shing Pik College

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

S.T.F.A. Lee Shau Kee College

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

Shun Tak Fraternal Association Leung Kau Kui College

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Internet Addiction Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Xue Yang

    JC School of Public Health and Primary Care, Faculty of Medicine, CUHK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

December 27, 2019

First Posted

February 6, 2020

Study Start

March 19, 2021

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

August 2, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations