| CTRI Number |
CTRI/2024/03/064689 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How does mindfulness help tackle excessive gaming habits? |
|
Scientific Title of Study
|
Efficacy of a Mindfulness integrated Cognitive Behavioural Intervention (MiCBT) for Gaming Disorder(GD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syed Yaseen Ahmed |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Clinical Psychology,
M.V. Govindaswamy Building (3rd Floor),
NIMHANS, Hosur Road,
Bengaluru.
National Institute of Mental Health and Neurosciences (NIMHANS),
Hosur Road,
Bengaluru.
Bangalore
KARNATAKA
560029
India |
| Phone |
8985281856 |
| Fax |
|
| Email |
yaseen.acad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Clinical Psychology,
M.V. Govindaswamy Building (3rd Floor),
NIMHANS, Hosur Road,
Bengaluru.
Bangalore
KARNATAKA
560029
India |
| Phone |
9886176879 |
| Fax |
|
| Email |
paulomi.sudhir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paulomi M Sudhir |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Clinical Psychology,
M.V. Govindaswamy Building (3rd Floor),
NIMHANS, Hosur Road,
Bengaluru.
KARNATAKA
560029
India |
| Phone |
9886176879 |
| Fax |
|
| Email |
paulomi.sudhir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material and Infrastructure:
National Institute of Mental Health and Neurosciences (NIMHANS),
Hosur Road,
Bengaluru,
Karnataka – 560029 |
| Monetary:
University Grants Commission – Junior Research Fellowship (UGC-JRF) |
|
|
Primary Sponsor
|
| Name |
University Grants Commission – Junior Research Fellowship (UGC-JRF) |
| Address |
University Grants Commission (UGC),Bahadur Shah Zafar Marg,
New Delhi - 110002 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Dr Paulomi M Sudhir |
National Institute of Mental Health and Neurosciences (NIMHANS) |
Behavioural Medicine Unit (BMU),
Department of Clinical Psychology,
M.V. Govindaswamy Building (Basement), Child and Adolescent Psychiatry Unit (CAP) and NCWB, 1B, 9th Main, 1st Stage, 1st Phase, BTM Layout, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore – 560029 & 560076.
Bangalore
KARNATAKA |
9886176879
paulomi.sudhir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committee - Behavioural Sciences |
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 |
Mindfulness Integrated Cognitive Behaviour Therapy (MiCBT) |
Mindfulness-integrated Cognitive Behaviour Therapy (MiCBT) from the MiCBT Institute is an evidence-based approach seamlessly blending mindfulness from the Vipassana tradition with core Cognitive Behaviour Therapy (CBT) methods. Comprising four stages, MiCBT offers a transdiagnostic framework to address psychological disorders, stress, and pain. The stages include Intrapersonal Regulation, emphasizing mindfulness, equanimity, and insight; Behavioural Regulation, integrating exposure methods; Interpersonal Regulation, applying skills in social situations; and Transpersonal Regulation, cultivating compassion and ethics to prevent relapse. MiCBT empowers individuals to manage thoughts, emotions, and relationships, fostering a compassionate and ethical mindset.
This intervention is offered to clients diagnosed with Gaming disorder over 10-12 sessions each lasting 75 minutes spread across 10-12 weeks. |
| Comparator Agent |
None |
The baseline period acts as a control condition for participants. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged between 16-25 years.
All genders.
Self-reported difficulties / caregiver reported difficulties with controlling their gaming
behavior.
Stabilized on medication for the past four weeks for those who are receiving pharmacological interventions.
Participants who can read and write English and who can communicate in one of the following languages : English, Hindi, Telugu. Sessions will be offered in face to face format and audio/video based format will be offered optionally. Face to face sessions will be preferred over the internet based session and only 20% of the session will be offered in the online format (to reduce dropout rate). |
|
| ExclusionCriteria |
| Details |
A diagnosis of a severe mental illness such as severe depression, psychosis, suicidality, substance use (except nicotine) or any other clinical condition that makes participation in the study difficult.
Individuals with organic or neurological conditions with functional impairments whose condition will prevent them from participation in the study.
Participants who have received more than 3 sessions of individual psychotherapy in the last 3 months specifically targeting GD (This criterion ensures that the effectiveness of MiCBT intervention can be evaluated independently) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A score of 25 or more on the The Internet Gaming Disorder Scale-Short-Form (IGDS9-SF) |
Baseline, Weekly, Post intervention and Followup. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual Analog Scale (VAS) to measure level of craving before and after intervention.
2. Clinical Global Impression Scale at pre-intervention, post-intervention and follow up time periods.
3. Depression Anxiety Stress Scales – 21 items (DASS-21) at pre-intervention, post-intervention and follow up time periods.
4. The World Health Organization Quality of Life Scale - Brief version (WHOQOL-BREF) at pre-intervention, post-intervention and follow up time periods.
5. Five Facet Mindfulness Questionnaire (FFMQ) pre-intervention, post-intervention and follow up time periods. |
Pre-intervention, Post-intervention and follow up time periods. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/07/2024 |
| 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="5"
Months="0"
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 - NO
|
|
Brief Summary
|
In 2019, the World Health Organization (WHO) recognized Gaming Disorder as a mental health issue in the ICD-11, with prevalence varying globally. However, this concern has received limited attention in India, marked by a scarcity of studies. Existing literature on Internet Gaming Disorder (IGD) shows limitations, including insufficient control groups, sample size justification, and follow-up data. Mindfulness-based interventions for IGD have gained support from systematic reviews and meta-analyses. The research seeks to examine MiCBT’s efficacy on disordered gaming and its impact on various psychological factors. The study’s findings are expected to inform treatment guidelines, validate MiCBT for IGD in the Indian context, and contribute to public health strategies addressing gaming addiction. The study is a single group, nonconcurrent, multiple-baseline, single-case design with baseline, post and follow-up assessments testing the efficacy of a Mindfulness integrated Cognitive Behavioural Intervention (MiCBT) for Gaming Disorder(GD). The participants will be seen at Behavioural Medicine Unit (BMU) and NIMHANS Centre for Wellbeing (NCWB) under the Department of Clinical Psychology, NIMHANS. The intervention consists of 10-12 psychotherapy sessions lasting 75 minutes each, conducted every week. The primary outcome measure is the scores on the Internet Gaming Disorder Scale-Short-Form at the end of 12 weeks and 3 months follow-up. The secondary outcomes will be craving, depression, anxiety and stress, impulsivity, mindfulness, quality of life and sleep quality at baseline, the end of 12 weeks (post intervention) and 3 months follow-up. |