| CTRI Number |
CTRI/2021/09/036112 [Registered on: 01/09/2021] Trial Registered Prospectively |
| Last Modified On: |
30/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study psychological strengths and difficulties in people who attempt suicide. |
|
Scientific Title of Study
|
Suicide attempt and correlates of resilience: a cross-sectional explorative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar Mysore Nagaraj |
| Designation |
Associate professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Psychiatry
KMC, Tiger circle, Manipal
KMC, Tiger circle
Udupi
KARNATAKA
576104
India |
| Phone |
09901911667 |
| Fax |
|
| Email |
nagarajakm24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhiram PN |
| Designation |
Senior resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Psychiatry
KMC, Tiger circle, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9481338686 |
| Fax |
|
| Email |
abhiram.pn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhiram PN |
| Designation |
Senior resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Psychiatry
KMC, Tiger circle, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9481338686 |
| Fax |
|
| Email |
abhiram.pn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry,Kasturba hospital, Kasturba Medical College, Manipal. |
|
|
Primary Sponsor
|
| Name |
Department of Psychiatry |
| Address |
kasturba Medical College, Manipal Academy of Higher education, Tiger Circle, Manipal - 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhiram PN |
Department of psychiatry, Kasturba Medical College and Kasturba Hospital |
Tiger circle
Manipal - 576104
Udupi
KARNATAKA |
9481338686
abhiram.pn@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X71-X83||Intentional self-harm, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All those who have done Suicide attempt and have been hospitalized or evaluated at out-patient-department. (Suicide attempt is defined as any nonfatal self-directed potentially injurious behavior with any intent to die as a result of the behavior.)
2. Age: 18 – 60 years.
3. Any gender. |
|
| ExclusionCriteria |
| Details |
1. Co-morbid acute major psychiatric illness.
2. Medically unstable patients.
3. Suicide attempt done under intoxication due to alcohol or other substance.
4. Those who refuse to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Scores on the Brief resilience scale, Columbia suicide severity rating scale, Depression anxiety stress scale, Standardized assessment of personality abbreviated scale and perceived stress scale.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation among scores of Brief resilience scale, Columbia suicide severity rating scale, Depression anxiety stress scale, Standardized assessment of personality abbreviated scale and perceived stress scale. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
03/09/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All those who have attempted suicide (as per the selection criteria listed below) will be approached for willingness to participate in this research study as per the approval of the ethics committee.All subjects will be assessed using a comprehensive semi-structured proforma to collect the socio-demographic and clinical details like birth and development, family history, personal history and related other information.
Following structured clinical scales will be applied by investigators. 1. Brief Resilience Scale (BRS) 2. Perceived Stress Scale (PSS) 3. Standardised Assessment of Personality – Abbreviated scale (SAPAS) 4. Depression, Anxiety and Stress Scale (DASS-21) 5. Columbia Suicide Severity Rating Scale (C-SSRS)
Scores on the above-mentioned scales are the primary outcome variables of interest. Correlation among clinical variables and scores on these scales will be assessed.
Participation in the study is completely voluntary. All subjects fulfilling eligibility criteria will be given a participation information sheet and the procedure followed will be explained in detail. The participant has the right to refuse or withdraw consent at any part of the study. In such an event, it ensured that the participant continues to receive the best possible care and treatment. Complete confidentiality will be maintained related to the information about the participant obtained during the course of the study.
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