| CTRI Number |
CTRI/2025/08/093707 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psychosocial intervention programmes (group session , lectures)] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating a psychosocial intervention to reduce internet addiction and improve mental well-being among adolescents in Goa" |
|
Scientific Title of Study
|
A study to assess effectiveness of Psychosocial Intervention Programme on internet addiction and related psychological factors among adolescents from Goa |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangam sawant |
| Designation |
Phd Scholar |
| Affiliation |
College of Nursing , Teerthanker Mahaveer University |
| Address |
College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.) 244001
College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.) 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8806077430 |
| Fax |
|
| Email |
sangsaw25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Jasline |
| Designation |
Principal |
| Affiliation |
College of Nursing , Teerthanker Mahaveer University |
| Address |
College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.) 244001
College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.) 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8279816167 |
| Fax |
|
| Email |
drjaslinejohn.msn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangam sawant |
| Designation |
Phd Scholar |
| Affiliation |
College of Nursing , Teerthanker Mahaveer University |
| Address |
College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.) 244001
College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.) 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8806077430 |
| Fax |
|
| Email |
sangsaw25@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, Teerthanker Mahaveer University, Moradabad |
|
|
Primary Sponsor
|
| Name |
Sangam Sawant |
| Address |
College of Nursing, Teerthanker Mahaveer University,
NH-24, Bagarpur, Delhi Road, Moradabad (U.P.) 244001 |
| Type of Sponsor |
Other [Self Sponsored ] |
|
|
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 |
| Yeshwant Sawant |
Shri. Bhumika Higher Secondary School |
Room No. 03 , Shri Bhumika HSS, Parye Post, Sankhalim , sattari Goa
North Goa
GOA |
9420425995
ysawant1965@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE TEERTHANKER MAHAVEER DENTAL COLLEGE & RESEARCH CENTRE, Delhi Road, Moradabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
I am screening for internet addiction among adolescent and will give psychosocial intervention programme (lectures, group discussions) to prevent the same |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
This is a pre-experimental one-group pretest-post test design with no comparator or control group. |
| Intervention |
Psychosocial intervention programme |
A structured psychosocial interventions including psychoeducation, time management techniques,explaining effects of internet addiction , how to prevent internet addiction and group discussions aimed at reducing internet addiction and improving psychological well-being among adolescents.
Mode of Delivery: Group Sessions
duration: everyday 1 hour for 7 days |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents aged 10 to 19 years.
Willingness to participate in the study and attend all intervention sessions.
Ability to understand and respond to the study questionnaires in English
Informed consent obtained from parents/guardians and assent from the adolescent. |
|
| ExclusionCriteria |
| Details |
Adolescents with a diagnosed psychiatric disorder (e.g., psychosis, severe depression, bipolar disorder) that requires clinical or pharmacological intervention.
Adolescents currently undergoing psychotherapy or counseling for internet addiction or any other psychological issues.
Adolescents with neurological disorders or intellectual disabilities that impair their ability to participate in the intervention or respond to questionnaires.
Adolescents who do not provide assent or whose parents/guardians do not provide consent.
Adolescents with visual, auditory, or communication impairments that limit their ability to engage with the intervention content. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome Name: Reduction in Internet Addiction
Type of Outcome: Primary
Outcome Description: Change in Internet Addiction scores as measured by Young’s Internet Addiction Test (IAT) from baseline to post-intervention (after 6–8 weeks).
|
Pre-intervention (baseline) and immediately post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome 1
Outcome Name: Change in Depression Levels
Outcome Description: Measured using the Depression subscale of DASS-21 at baseline and post-intervention.
|
Pre-intervention (baseline) and immediately post-intervention. |
Secondary Outcome 2
Outcome Name: Change in Anxiety Levels
Outcome Description: Measured using the Anxiety subscale of DASS-21 at baseline and post-intervention. |
Pre-intervention (baseline) and immediately post-intervention. |
Secondary Outcome 3
Outcome Name: Change in Stress Levels
Outcome Description: Measured using the Stress subscale of DASS-21 at baseline and post-intervention |
Pre-intervention (baseline) and immediately post-intervention. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
06/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to assess the effectiveness of a psychosocial intervention programme in reducing internet addiction and improving related psychological factors among adolescents in Goa. The intervention includes raising awareness about internet addiction, explaining its consequences and prevention strategies, and providing techniques to reduce anxiety, stress, and depression through lectures and group discussions. The hypothesis is that adolescents receiving the intervention will show a significant reduction in internet addiction scores measured by Young’s Internet Addiction Test, along with improvements in depression, anxiety, and stress levels measured by the DASS-21 scale, compared to their baseline scores. |