| CTRI Number |
CTRI/2025/09/093989 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral Other (Specify) [NEUROCOGNITIVE THERAPY] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Helping Adolescents with Internet Gaming Addiction: Effects of a Brain-Training Program |
|
Scientific Title of Study
|
APPLICABILITY OF A BRIEF NEUROCOGNITIVE
INTERVENTION FOR ADOLESCENTS WITH INTERNET GAMING DISORDER: THE IGNITE-A TRIAL |
| Trial Acronym |
IGNITE-A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KRITI KANWAR |
| Designation |
PhD SCHOLAR |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI |
| Address |
Child and adolescent centre, Department of clinical psychology, CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI
Ranchi JHARKHAND 834006 India |
| Phone |
7023753844 |
| Fax |
|
| Email |
Kritikanwar369@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
KRITI KANWAR |
| Designation |
PhD SCHOLAR |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI |
| Address |
CHILD AND ADOLESCENT CENTRE, DEPARTMENT OF CLINICAL PSYCHOLOGY, CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI
Ranchi JHARKHAND 834006 India |
| Phone |
7023753844 |
| Fax |
|
| Email |
Kritikanwar369@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr VARUN SMEHTA |
| Designation |
PROFESSOR OF PSYCHIATRY |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHITARY, RANCHI |
| Address |
CHILD AND ADOLESCENCE CENTRE, DEPARTMENT OF PSYCHIATRY, CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI
Ranchi JHARKHAND 834006 India |
| Phone |
834006 |
| Fax |
|
| Email |
vs_mehta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KRITI KANWAR |
| Address |
DEPARTMENT OF CLINICAL PSYCHOLOGY, CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| KRITI KANWAR |
CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI |
CHILD AND ADOLESCENCE CENTRE, DEPARTMENT OF CLINICAL PSYCHOLOGY Ranchi JHARKHAND |
7023753844
Kritikanwar369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, CIP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F638||Other impulse disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief neurocognitive intervention for adolescents with gaming addiction |
Name of intervention: Neurocognitive Intervention for Gaming Addiction in Adolescents
Description: The intervention is a structured neurocognitive training program aimed at enhancing executive functions (attention, working memory, response inhibition, and cognitive flexibility) among adolescents with gaming addiction.
Mode of delivery: Individual, computer-based tasks combined with therapist-guided sessions.
Frequency & duration: 12 sessions (3 sessions per week, each lasting 45–60 minutes) over 4 weeks.
Therapist qualifications: Clinical Psychologist trained in neurocognitive interventions.
Primary objective: To reduce problematic gaming behavior and improve neurocognitive control (self-regulation, attention, memory). |
| Comparator Agent |
Treatment as Usual (TAU) / Psychoeducation and Supportive Counseling |
Description: Participants in the comparator arm will receive standard psychoeducation about healthy gaming habits, time management, sleep hygiene, and lifestyle balance, along with supportive counseling.
Mode of delivery: Individual sessions with a Clinical Psychologist.
Frequency & duration: 4 sessions (once a week, 30–40 minutes each) over 4 weeks.
Primary objective: To provide general awareness and support, without structured neurocognitive training. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents with problematic online gaming behaviours as their main complaint who endorse at least five out of nine criteria of Internet Gaming Disorder in DSM 5. Adolescents of either gender aged 13 years to less than 19 years. Adolescents providing written assent to participate in the study. Caregivers providing written informed consent for participation of their adolescent. Right handed adolescents who can speak, read and write in English. |
|
| ExclusionCriteria |
| Details |
Adolescents with dependence on substances such as alcohol, cannabinoids, solvents, opioids, stimulants, cocaine, sedatives, hypnotics and hallucinogens except nicotine and caffeine.
Adolescents diagnosed with genetic syndromes or neurodevelopmental disorders known to affect executive functions such as Fragile X syndrome, Williams syndrome, intellectual disability, ADHD, communication disorder, autism spectrum disorder, specific learning disorder, or motor disorder.
Adolescents with conduct disorder, neurological illness, traumatic brain injury, or any physical disability interfering with participation in the study.
Adolescents with past or current history of psychosis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes include improvement in executive functioning (attention, planning, mental flexibility, working memory, and response inhibition), reduction in gaming addiction severity, and enhancement of quality of life in adolescents with Internet Gaming Disorder in the experimental group compared to the control group.
|
7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes include improvement in emotional regulation, academic performance, social functioning, sleep quality, motivation for alternative activities, self-esteem, and reduction in parental stress.
|
11 weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="11" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Kritikanwar369@gmail.com].
- For how long will this data be available start date provided 20-01-2029 and end date provided 01-01-0001?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized controlled trial evaluating a brief neurocognitive intervention for adolescents with internet gaming disorder. The participants are adolescents aged 13 to 19 years recruited from clinical and community settings. The intervention combines the Executive Functions module of the Brain Wave R program with Behaviour Modification strategies from the PIPATIC program. The experimental group receives the structured intervention and the control group receives treatment as usual. Primary outcomes include improvement in executive functioning domains, reduction in gaming addiction severity, and enhancement of quality of life. Secondary outcomes include emotional regulation, social and academic functioning, sleep quality, motivation, and self esteem. The study is conducted at the Central Institute of Psychiatry Ranchi |