| CTRI Number |
CTRI/2023/07/055211 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
12/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Other (Specify) [Developing an App] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing a Mobile Application to help young people with mental health issues in colleges and clinics in Chennai, India |
|
Scientific Title of Study
|
A Comprehensive, collaborative and sustainable intervention package to help young people with depression in educational and clinical settings in Chennai, India |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRF-SR/04/FEB-2022 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thara R |
| Designation |
Vice Chairman, Schizophrenia Research Foundation |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Department of Psychiatry Schizophrenia Research Foundation R/7A, North Main Road, Anna Nagar West Extension
Chennai
TAMIL NADU
6000101
India
Chennai
TAMIL NADU
6000101
India |
| Phone |
9840238870 |
| Fax |
|
| Email |
thara@scarfindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Thara R |
| Designation |
Vice Chairman, Schizophrenia Research Foundation |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Department of Psychiatry Schizophrenia Research Foundation R/7A, North Main Road, Anna Nagar West Extension
Chennai
TAMIL NADU
6000101
India
Chennai
TAMIL NADU
6000101
India |
| Phone |
9840238870 |
| Fax |
|
| Email |
thara@scarfindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Thara R |
| Designation |
Vice Chairman, Schizophrenia Research Foundation |
| Affiliation |
Schizophrenia Research Foundation |
| Address |
Department of Psychiatry Schizophrenia Research Foundation R/7A, North Main Road, Anna Nagar West Extension
Chennai
TAMIL NADU
6000101
India
Chennai
TAMIL NADU
6000101
India |
| Phone |
9840238870 |
| Fax |
|
| Email |
thara@scarfindia.org |
|
|
Source of Monetary or Material Support
|
| Indira Foundation, 939 Coast Blvd., Unit 20A La Jolla, CA 92037, USA |
|
|
Primary Sponsor
|
| Name |
Indira Foundation |
| Address |
939 Coast Blvd., Unit 20A La Jolla, CA 92037, USA
|
| Type of Sponsor |
Other [Non-governmental foundation] |
|
|
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 Thara R |
Schizophrenia Research Foundation (SCARF) |
Schizophrenia Research Foundation, R/7A, North Main Road, Anna Nagar West Extension, Chennai – 600101, Tamil Nadu, India
Chennai
TAMIL NADU |
9840238870
thara@scarfindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of SCARF |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F30-F39||Mood [affective] disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
YES App-Peer Support Volunteer |
A secure mobile application will be developed to host and deliver a robust and widely used depression screening tool to screen for depression, anxiety and stress among young people. Along with this, regular monitoring and tracking of wellbeing will be done using dedicated applications which document the changes in the wellbeing, stressors, emotions, and other related parameters on a regular basis. Patient Health questionnaire-9 (PHQ-9) will be used to screen for depression. PHQ-9 has high sensitivity and specificity to identify depression and suicidal ideation from the general population and young people. The test results will be provided to the user and all the user information will be kept confidential. The mobile app can be used at all times and the assessments will be completed at baseline, 6 months, 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Young people in the age group of 18-25 will be the target population for the proposed project. These young people will be identified and recruited into the project from two settings as mentioned above, namely colleges and SCARF youth clinic. Willing to provide written informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Not willing to provide written informed consent to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient Health questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-(GAD-7), Perceived Stress Scale-(PSS) |
Baseline, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To improve mental health literacy (MHL) about common mental health issues including depression among young people.
To monitor their wellbeing & screen them for depression
To provide information on referral pathways based on symptom severity
To deliver interventions for depression through mobile based applications & peer support
a. At the educational institutions & follow-up through peer support
b. At the clinical setting & follow-up through case managers
To sustain the peer support training through trainer of trainer (ToT) model |
Baseline 6 months 12 months |
|
|
Target Sample Size
|
Total Sample Size="15300"
Sample Size from India="15300"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2023 |
| 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="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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 03-07-2025 and end date provided 03-09-2025?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Depression is a widespread condition affecting individuals of all age groups, with a significant increase in its occurrence among children and adolescents. In India, the impact of depression on the youth is particularly concerning, as it leads to various negative outcomes such as hospitalizations, recurring episodes, psychosocial impairment, substance abuse, and even suicide. Early detection of depression in young people is crucial for improving prognosis and implementing effective interventions. This can be achieved through strategies like mental health literacy (MHL) and validated screening measures. MHL aims to increase knowledge about mental health and disorders, enabling early recognition and treatment-seeking. Validated screening measures, such as the Patient Health Questionnaire and Beck Depression Inventory, are essential for accurate diagnosis, efficient patient care, and monitoring treatment response. Online interventions hold promise in engaging young people and providing them with information and support. The proposed pilot study aims to develop and test a comprehensive intervention package targeting 18-25-year-old individuals with depression in educational institutions and clinical settings in Chennai, India. The study includes objectives such as improving mental health literacy, monitoring wellbeing and screening for depression, providing referral information based on symptom severity, delivering interventions through mobile applications and peer support, and sustaining peer support training. |