| CTRI Number |
CTRI/2024/07/071180 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Suicide Prevention Training for Frontline Healthcare Workers of the National Tuberculosis Elimination Programme |
|
Scientific Title of Study
|
Effectiveness of Online Suicide Prevention (Gatekeeper) E-Module Training Compared to In-Person Training for Frontline Healthcare Workers of the National Tuberculosis Elimination Programme (NTEP) in Karnataka - An Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Guru S |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health And Neuro Sciences (NIMHANS), Bengaluru |
| Address |
Department of Psychiatry, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9901758577 |
| Fax |
|
| Email |
drgsgowda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Guru S |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health And Neuro Sciences (NIMHANS), Bengaluru |
| Address |
Department of Psychiatry, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9901758577 |
| Fax |
|
| Email |
drgsgowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Guru S |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health And Neuro Sciences (NIMHANS), Bengaluru |
| Address |
Department of Psychiatry, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9901758577 |
| Fax |
|
| Email |
drgsgowda@gmail.com |
|
|
Source of Monetary or Material Support
|
| National TB Elimination Programme and District Mental Health Programme, Directorate, Health and Family Welfare Services, National Health Mission, Government of Karnataka, Arogya Soudha, Madagi Road, Bengaluru - 560023, Karnataka State, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research, New Delhi |
| Address |
Indian Council of Medical Research (ICMR), Government of India, New Delhi |
| 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 |
| Guru S |
National Institute of Mental Health And Neuro Sciences (NIMHANS) |
Department of Psychiatry
Bangalore
KARNATAKA |
9901758577
drgsgowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee (Behavioural Science Division), NIMHANS, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health Workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In person training - Gate Keeper Suicide Prevention Training (GKSPT) |
Mode of DELIVERY (in-person) -Gate Keeper Suicide Prevention Training (GKSPT) equips individuals with the specific attitudes, knowledge, and skills needed to prevent suicide. The trainings key components are preparing, connecting, understanding, assisting, and networking. Through GKSPT, individuals can identify community members who are at risk of suicide and direct them towards additional support as needed. GKSPT has successfully imparted knowledge, built skills, and shaped attitudes in military personnel, school staff, clinicians, and peer helpers.
The intervention consists of 10 modules, each lasting 20 to 30 minutes.
The in-person training will be delivered over two (2) days, incorporating didactic methods, role-playing, quizzes, and adult learning principles. |
| Intervention |
Online e-module training - Gate Keeper Suicide Prevention Training (GKSPT) |
Mode of DELIVERY (e -module, online). Gate Keeper Suicide Prevention Training (GKSPT) equips individuals with the specific attitudes, knowledge, and skills needed to prevent suicide. The trainings key components are preparing, connecting, understanding, assisting, and networking. Through GKSPT, individuals can identify community members who are at risk of suicide and direct them towards additional support as needed. GKSPT has successfully imparted knowledge, built skills, and shaped attitudes in military personnel, school staff, clinicians, and peer helpers.
The Online e-module training intervention consists of 10 modules, each lasting 15 to 20 minutes.
The training is recommended to be completed over 10 days using an online asynchronous learning management solution (e-module), which includes multiple-choice questions and end-of-module assessments. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
a) Age between 18 – 60 years.
b) Any gender.
c) At least six months of working experience in the KSTEP programme.
d) Willingness to participate and undergo the gatekeeper suicide prevention training (GKSPT) and the Suicide Risk Assessment App
|
|
| ExclusionCriteria |
| Details |
nclusion Criteria:
a) Age between 18 – 60 years.
b) Any gender.
c) At least six months of working experience in the KSTEP programme.
d) Willingness to participate and undergo the gatekeeper suicide prevention training (GKSPT) and the Suicide Risk Assessment App
Exclusion Criteria:
a) Those who get superannuation from the service in the next 24 months.
b) Refusal to give an informed consent
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the effectiveness of GateKeeper Suicide Prevention (GKSPT) online e-module training compared to in-person training for frontline healthcare workers (HCWs) of the National Tuberculosis Elimination Programme (NTEP) in Karnataka |
At baseline (0 months), 3 months, 6 months, 9 months, 12
months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the identifying suicidality (including suicidal ideation, attempts, and mortality) and their linkage to the nearest District Mental Health Programme (DMHP) among TB patients referral pattern between online e-module and in-person training for frontline healthcare workers (HCWs). |
0 months, 3 months, 6 months, 9 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="2"
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
|
1) Title: Effectiveness of Online Suicide Prevention (Gatekeeper) E-Module Training Compared to In-Person Training for Frontline Healthcare Workers of the National Tuberculosis Elimination Programme (NTEP) in Karnataka - An Interventional Study 2.1 - Background: Suicide-related mortality rates in tuberculosis (TB) patients are twenty to seventy times higher than the rate of suicide among the general population in India. Therefore, gatekeeper suicide prevention training (GKSPT) is considered an effective suicide prevention strategy for identifying warning signs, risks, and protective factors associated with suicide. The current proposal investigates the effectiveness of GKSPT online training compared to in-person training for the healthcare workers (HCWs) of the National Tuberculosis Elimination Programme (NTEP). 2.2 – Novelty: This would be the first study to develop, validate, and explore the effectiveness of a GKSPT online e-module training compared to in-person training, as well as an added Suicide Risk Assessment (SRA) app, for the HCWs of NTEP. 2.3 – Objectives: This study aims to investigate the effectiveness of GKSPT online e-module training compared to in-person training for the HCWs of NTEP. 2.4 - Methods: NIMHANS will develop and validate Gatekeeper Suicide Prevention (GKSPT) content, collaborating with III-T Bengaluru; an online e-module and SRA App for suicide risk assessment will be jointly developed. Through randomized district-level allocation, NTEP HCWs will receive either online or in-person GKSPT training, with access to the SRA App as a variable. The study will measure pre- and post-training changes in HCWs’ ability to identify suicidality in TB patients and assess skill retention. By conducting follow-up evaluations, the study will determine the acquired skill retention in suicide prevention among HCWs. 2.5 - Expected Outcomes: The study is expected to yield insights into the relative effectiveness of the GKSPT online e-module training and In-person training for frontline HCWs in the NTEP. Additionally, HCWs anticipated demonstrating improved skills in identifying warning signs and risk factors associated with suicidal ideation among TB patients and making appropriate and timely referrals to mental health services. |