| CTRI Number |
CTRI/2024/12/078838 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Nomophobic therapy on Behaviour Emotion and developing Insight among High School students with Nomophobia at Selected Schools |
|
Scientific Title of Study
|
Nomophobia Effectiveness of Nomophobic therapy on Behaviour Emotion and developing Insight among High School students with Nomophobia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujitha Jebarose Jebanesy T |
| Designation |
Research Scholar |
| Affiliation |
Bharath Institute of Higher Education and Research |
| Address |
Department of Nursing
Bharath Institute of Higher Education and Research
173 Agharam Road
Selaiyur
Chennai
Chennai TAMIL NADU 600073 India |
| Phone |
8681979871 |
| Fax |
|
| Email |
sujisiga@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vasantha S |
| Designation |
Principal |
| Affiliation |
Bharath College of Nursing Bharath Institute of Higher Education and Research |
| Address |
Bharath College of Nursing
Bharath Institute of Higher Education and Research
173 Agharam Road
Selaiyur
Chennai
Chennai TAMIL NADU 600073 India |
| Phone |
8681979871 |
| Fax |
|
| Email |
vasanthishanju@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sujitha Jebarose Jebanesy T |
| Designation |
Research scholar |
| Affiliation |
Bharath Institute of Higher Education and Research |
| Address |
Department of Nursing
Bharath Institute of Higher Education and Research
173 Agharam Road
Selaiyur
Chennai
Chennai TAMIL NADU 600073 India |
| Phone |
8681979871 |
| Fax |
|
| Email |
sujisiga@gmail.com |
|
|
Source of Monetary or Material Support
|
| SKDJ Higher Secondary School, Thiruverkadu, Chennai-600077 Tamilnadu India - Infrastructure Support |
|
|
Primary Sponsor
|
| Name |
Sujitha Jebarose Jebanesy T |
| Address |
Bharath Institute of Higher Education and Research
Selaiyur
Chennai
Tamilnadu
India
600073
|
| 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 |
| NrSujitha Jebarose Jebanesy T |
SKDJ Higher Secondary School |
Class room no 8th E
Balaji Govinda Nagar
Thiruverkadu
Chennai 600077
Thiruvallur TAMIL NADU |
8681979871
sujisiga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaarath Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mild and Moderate level of Nomophobia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Intervention |
During the data collection period, school routines will be followed, and after the pre- and post-tests, students will receive Nomophobic Therapy, an interventional package designed to treat nomophobia and its associated psychological, behavioral, and emotional difficulties. The therapy includes two main components: a Nomophobia Lecture and Cognitive Behavioral Therapy (CBT). The Nomophobia Lecture, lasting 40 minutes, is a PowerPoint-assisted program that educates students about nomophobia, its definition, causes, symptoms, prevention, and management, aiming to raise awareness and help students recognize the disorder they may unknowingly suffer from. Following the lecture, CBT sessions will be conducted over 8 weeks, each lasting 40 minutes in the afternoons. The sessions focus on helping students identify and reframe the automatic thoughts, emotions, and behaviors linked to nomophobia. A group of 20 students will meet weekly on Saturdays, where each session begins with reviewing homework from the previous week, followed by new material and concluding with assigning homework for the next session. The program aims to raise awareness, modify maladaptive behaviors, and improve emotional and behavioral responses to mobile phone dependence |
| Intervention |
Nomophobic Therapy |
Nomophobic therapy is an interventional package designed to treat nomophobia and psychological behavioural and emotional difficulties associated with nomophobia.
This interventional package consists of the following.
Nomophobia lecture
Cognitive Behaviour Therapy (CBT)
Nomophobic Lecture
It is a power point assisted instructional program about Nomophobia its Meaning Incidence Risk Factors Causes Types Signs and Symptoms Prevention Management and Self-assessment techniques. This teaching will be given in the second session for about a period of 40 mts followed by the Introduction session.
The goal of this teaching is to educate the students on nomophobia and familiarize them with this noveldisorder that they may not be aware of but they actually suffer with.This teaching aims to impart knowledge on Nomophobia and make the students familiar with this novel disorder which they suffer with not familiar of it. Acquiring a deeper understanding of the subject, delivers in-depth knowledge about nomophobia will also help ones insight into this concept.
CBT for students with Nomophobia
Cognitive Behaviour Therapy (CBT) is a short-term psychotherapy approach that focuses on the interplay between our thoughts emotions and actions. It is designed to help school students with Nomophobia by reconstructing the automatic thoughts ofNomophobia.
The therapist applies many techniques to raise awareness among students about their emotional and behavioural problems associated with Nomophobia and replacing maladaptive behaviours and emotions with adaptive ones, using an integrative approach.
The program includes8 weekly sessions of 40 minutes each, will be held in schools in the afternoonhours. The group meetings will be performed through a contact session for a group of 20 students in group.The facilitator meet the participants every Saturday to administer the program. Each group meeting will begin by examining participants’ homework from the previous session then new structured intervention material will be introduced and the groups will be finished with giving homework for the next session.
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Students who have mild to moderate level of Nomophobia
Students and their Parents, giving consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Students , diagnosed with any kind of psychiatric illness and undergoing treatment
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Nomophobia symptoms in high school students, measured by changes in behavior, emotional regulation, and insight development regarding smartphone dependency |
Baseline assessment-Day 0
Post test- 1-3 days after administering intervention for 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvements in academic performance, enhanced social interactions, reduced stress levels, and the development of healthier coping strategies for managing smartphone separation anxiety. |
Baseline assessment-Day 0
Post test- A month after administering intervention for 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="320" Sample Size from India="320"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="4" 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, titled "Nomophobia: Effectiveness of Nomophobic Therapy on Behavior, Emotion, and Developing Insight Among High School Students with Nomophobia," uses quantitative research approach with the following Objectives Evaluate the effectiveness of Nomophobic Therapy on behaviour, emotion and developing insight regarding Nomo phobia among High school students with Nomophobia Correlate the Behaviour , Emotion and level of insight regarding Nomo phobia among high school students with Nomophobia
This study employs a Randomized Controlled Trial (RCT) design to evaluate the impact of an 8-session Nomophobic Therapy intervention over one month, with two sessions per week. The study will begin with a pre-assessment on Day 0 to establish baseline measures of behavior, emotional responses, and insight regarding nomophobia. Following the intervention, a post-test will be conducted within 1-3 days to assess changes in these dimensions. Through quantitative analysis, the study aims to provide valuable insights into the therapeutic benefits of Nomophobic Therapy for high school students struggling with nomophobia.
In conclusion, this study aims to assess the effectiveness of Nomophobic Therapy in reducing nomophobia among high school students and to explore the correlations between their behavior, emotional responses, and insights. The findings could provide valuable insights for developing effective interventions to support adolescents facing nomophobia. |