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CTRI Number  CTRI/2025/08/092584 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Psychotherapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the efficacy of Modified Multimodal Psychotherapy Intervention for Internet Gaming Disorder in comparison to a control intervention of supportive psychotherapy and stress management. 
Scientific Title of Study   Modified Multimodal Psychotherapy Intervention for Internet Gaming Disorder (IGD): A Randomised Control Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ahsana T H 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Clinical Psychology, third floor, Dr. M V Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences, Hosur road, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  8078239589  
Fax    
Email  ahsanahakeem@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Anand 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Clinical Psychology, third floor, Dr. M V Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences, Hosur road, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  9886276668  
Fax    
Email  nitinanand19800@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nitin Anand 
Designation  Additional Professor 
Affiliation  National Institute of Mental Health and Neuro Sciences 
Address  Department of Clinical Psychology, third floor, Dr. M V Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences, Hosur road, Bangalore


KARNATAKA
560029
India 
Phone  9886276668  
Fax    
Email  nitinanand19800@gmail.com  
 
Source of Monetary or Material Support  
University Grants Commision - Junior Research Fellowship (UGC-JRF) 
 
Primary Sponsor  
Name  University Grants Commision Junior Research Fellowship  
Address  Bahadur Shah Zafar Marg, New Delhi, India - 110002 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ahsana T H  National Institute of Mental Health and Neuro Sciences  Third floor, Department of Clinical Psychology, Dr. M. V. Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences, Hosur Road, Near Bangalore Milk Diary, Bangalore, 560029
Bangalore
KARNATAKA 		 8078239589

ahsanahakeem1510@gmail.com 
Ahsana T H  NIMHANS Centre for Well-being  Services for Healthy Use of Technology (SHUT) Clinic, NIMHANS Centre for Well-being, 1B, 9th Main, 1st Stage, BTM Layout, Bengaluru - 560076
Bangalore
KARNATAKA 		 8078239589

ahsanahakeem1510@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Mental Health and Neuro Sciences, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multimodal Psychotherapy Intervention for Internet Gaming Disorder (IGD)  Multimodal psychotherapy intervention for Internet Gaming Disorder (IGD) is a therapeutic approach that incorporates various psychotherapy strategies to address different aspects of excessive internet gaming and enhance an individuals overall well-being. This includes increasing the motivation of the individual towards realistic change, addressing the negative beliefs or thoughts associated with gaming, teaching digital hygiene skills to reduce the gaming symptoms and encouraging healthy use of technology, enhancing self-esteem and developing a sense of personal agency, enhancing interpersonal effectiveness, addressing parent-child communication difficulties and helping with relapse prevention. Total duration of the intervention is 10-12 weeks.  
Comparator Agent  Supportive psychotherapy and stress management for Internet Gaming Disorder (IGD)  The interevention involves receiving information about Internet Gaming Disorder (IGD) and supportive therapy and learning stress management and digital hygiene skills, which provide valuable insights and practical skills for managing gaming activities. Total duration of the intervention is 10-12 weeks.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  28.00 Year(s)
Gender  Both 
Details  Individuals reporting excessive gaming and associated challenges and with a severity score of equal to or more than 25 on the Internet Gaming Disorder Scale - Short-form (IGDS9-SF)
Individuals who have stabilized on pharmacological interventions for the past 4 weeks
Individuals who can read, write and understand English and communicate in either English or Malayalam
 
 
ExclusionCriteria 
Details  Individuals with the diagnosis of psychiatric disorders such as schizophrenia, psychosis, bipolar affective disorder, severe depression, suicidal risk, substance use and substance dependence or any other clinical condition that makes it difficult to participate in the study
Individuals with neurological conditions/organicity/medical conditions that affect their participation in the study
Individuals with intellectual developmental disorder, severe symptoms of autism spectrum disorder, attention-deficit hyperactivity disorder or other neurodevelopmental disorders that hinder their participation in the current study
Individuals who have undergone psychotherapy in the past 3 months or currently undergoing psychotherapy that is addressing internet gaming disorder.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Gaming severity, Internet addiction, clinical global impression - severity of illness and global improvement, socio-occupational functioning  Primary outcomes are measured at baseline, in-between intervention (at week 4, 7, 10 and 12), post intervention (after 10-12 weeks) & follow-up after 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Gaming motives, maladaptive gaming cognitions, depression, anxiety, emotion regulation & well-being  Secondary outcomes are measured at baseline, post intervention (after 10-12 weeks) & follow-up after 4 weeks. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/09/2025 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ahsanahakeem1510@gmail.com].

  6. For how long will this data be available start date provided 01-07-2028 and end date provided 30-06-2033?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to modify the multimodal psychotherapy intervention to address gaming symptoms and the multiple psychological risk factors involved in the development and maintenance of Internet Gaming Disorder (IGD) and assess its efficacy in treating IGD. This is a parallel-arm, randomized, controlled design with an intervention group and a control group. Intervention group receives modified multimodal psychotherapy intervention for IGD and control group receives supportive psychotherapy and stress management techniques. Assessments will be done at the baseline, post-intervention, and follow up at 4 weeks and 12 weeks, if possible. 
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