| CTRI Number |
CTRI/2024/05/067561 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Suicide and its determinants |
|
Scientific Title of Study
|
The association of impulsivity response inhibition and childhood adversities to self harm or suicide |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajvi Amlani |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical college, Manipal, Udupi |
| Address |
Department of psychiatry, Kasturba Medical college, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7263956872 |
| Fax |
|
| Email |
amlanirajvi11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar MN |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical college, Manipal, Udupi |
| Address |
Department of psychiatry, Kasturba Medical college, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9901911667 |
| Fax |
|
| Email |
anilkumar.nagaraj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar MN |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical college, Manipal, Udupi |
| Address |
Department of psychiatry, Kasturba Medical college, Manipal, Udupi
KARNATAKA
576104
India |
| Phone |
9901911667 |
| Fax |
|
| Email |
anilkumar.nagaraj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Kasturba medical college, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical college |
| Address |
Kasturba Medical College, Tiger circle, Manipal, Udupi District 576104 |
| Type of Sponsor |
Private 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 Rajvi Amlani |
Kasturba Hospital, Manipal |
Department of psychiatry, Kasturba hospital,Manipal, Udupi 576104
Udupi
KARNATAKA |
7263956872
amlanirajvi11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics committee - Student research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X71-X83||Intentional self-harm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of any gender, above the age of 18 who can provide informed consent and are actively/willing to participate in the assessment procedures
2.Intentional Self-Harm/suicide attempts in the last 2 weeks.
3.Participants who can read and write in Kannada/English. |
|
| ExclusionCriteria |
| Details |
1.Cognitive Impairment
2.Inability to cooperate with the interview |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Columbia-Suicide Severity Rating Scale(CSSRS)
Barratt Impulsiveness Scale (BIS-11)
Stop signal task(SST)
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Childhood Experiences (ACE) Questionnaire |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
30/05/2024 |
| 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="1"
Months="3"
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 investigate the association of impulsivity, response inhibition, and childhood adversities with intentional self-harm/suicide attempts among individuals; Objectives: 1. To investigate the association of response inhibition to intentional self-harm/suicide attempts among individuals. 2. To investigate the association of impulsivity to intentional selfharm/suicide attempts among individuals. 3. To investigate the association of childhood adversities to intentional self-harm/suicide attempts. 4. To investigate the Mediating role of response inhibition, childhood adversities, and impulsivity to self-harm/suicide attempt. Phase 1 includes approvals from the Department scientific committee (obtained), Institution Ethics Committee, and CTRI registration. The necessary scales have been translated to kannada as per WHO guidelines.Phase 2 involves recruiting patients meeting inclusion criteria from the psychiatry departments at KMC and consultation liaison psychiatry at KH. Informed consent will be obtained with translated information sheets. Sociodemographic data will be collected, followed by administering the HMSE,CSSRS,BIS-11,ACE questionnaire, and Stop signal task via laptop/computer with the psytoolkit software. The estimated time for each assessment is: sociodemographic proforma(15 mins),HMSE(15mins),CSSRS(20 mins),BIS 11(15 mins), Stop signal task(15 mins), ACE questionnaire(15 mins), totaling 95minutes for the entire interview |