| CTRI Number |
CTRI/2021/11/037821 [Registered on: 03/11/2021] Trial Registered Prospectively |
| Last Modified On: |
15/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Internet overuse in mental disorder |
|
Scientific Title of Study
|
Internet addiction in patient of common mental disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajeet Sidana |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Level-V, Department of Psychiatry,GMCH-32, Chandigarh
Chandigarh
CHANDIGARH
160036
India |
| Phone |
9646121614 |
| Fax |
|
| Email |
ajeetsidana@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Level-V, Department of Psychiatry,GMCH-32, Chandigarh
CHANDIGARH
160036
India |
| Phone |
9646121614 |
| Fax |
|
| Email |
ajeetsidana@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Level-V, Department of Psychiatry,GMCH-32, Chandigarh
CHANDIGARH
160036
India |
| Phone |
9646121614 |
| Fax |
|
| Email |
ajeetsidana@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital,Sector 32,Pin code- 160030, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
GMCH Sector 32 Chandigarh Pincode- 160036 |
| Type of Sponsor |
Government medical college |
|
|
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 Ajeet Sidana |
GMCH-32,Chandigarh |
Psychiatry OPD, B-BLock, Level-4, GMCH-32,Chandigarh
Pincode- 160030
Chandigarh
CHANDIGARH |
9646121614
ajeetsidana@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GMCH, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, (2) ICD-10 Condition: F33||Major depressive disorder, recurrent, (3) ICD-10 Condition: F32||Major depressive disorder, singleepisode, (4) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed with CMD- As per ICD-10- F10-19, F32-33, F40-48
2.Age more than 18 years
3. Patients having internet access
4. Patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
1. Psychotic Disorder and Bipolar Disorder
2. Severe depression with psychotic symptoms |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Internet Addiction measured using Youngs Internet Addiction |
0 (Baseline)- To be assessed only once as it is a cross sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association between severity of mental illness
with severity of internet addiction. |
0 (Baseline)- To be assessed only once as it is a cross sectional study |
|
|
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)
|
15/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims at identifying the extent of internet use and addiction in psychiatry patients and its association with severity of illness. Internet addiction is characterized by excessive or poorly controlled preoccupations, urges or behaviours regarding computer use and internet access that lead to impairment or distress. Although there is huge amount of data on the prevalence of internet addiction (IA) in healthy population but there is a paucity of data on internet addiction in patients with mental illness. Common mental morbidity represents a group of disorders which are highly common and are often misdiagnosed as physical illnesses in primary care settings leading to their mismanagement and resulting in long term disability. It includes depression (excluding severe depression with psychotic symptoms), neurosis and substance use disorders (excluding tobacco use disorders). The study will help to understand the extent of internet addiction by providing prevalence and further the association with severity of illness in patients with common mental disorders.
|