| CTRI Number |
CTRI/2026/03/105646 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study aimed to assess reduction in suicidal thoughts and behaviour between two groups of participants with suicide attempt where one of them subsequently receiving usual care and another group receiving safety planning intervention and periodic follow-ups along with usual care. |
|
Scientific Title of Study
|
A comparative study on safety planning intervention and periodic follow-up contacts versus usual care on patients with suicide attempt attending emergency department of tertiary medical care. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPGME&R/IEC/2024/0715-B |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayan Mondal |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Psychiatry, IPGMER and SSKM Hospital
Kolkata
WEST BENGAL
700025
India |
| Phone |
7980261230 |
| Fax |
|
| Email |
sayan.mondal1729@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUJIT SARKHEL |
| Designation |
Professor |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Psychiatry, IPGMER and SSKM Hospital
Kolkata
WEST BENGAL
700025
India |
| Phone |
9836074700 |
| Fax |
|
| Email |
sujitsarkhel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sayan Mondal |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Psychiatry, IPGMER and SSKM Hospital
WEST BENGAL
700025
India |
| Phone |
7980261230 |
| Fax |
|
| Email |
sayan.mondal1729@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH |
| Address |
IPGME&R and SSKM Hospital, 244 A. J. C. Bose Road, Kolkata 70020 |
| 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 |
| SAYAN MONDAL |
IPGME&R AND SSKM HOSPITAL |
244, A.J.C. Bose Road, Kolkata 700 020
EMERGENCY DEPARTMENT
EMERGENCY OBSERVATION WARD(EOW)
Kolkata
WEST BENGAL |
7980261230
sayan.mondal1729@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
| IPGME&R Research Oversight Committee |
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 |
| Intervention |
SAFETY PLANNING INTERVENTION WITH PERIODIC FOLLOW UP CONTACTS |
Participants will receive a structured Safety Planning Intervention (SPI) delivered during emergency department visit, including identification of warning signs, internal coping strategies, social support contacts, professional resources, and means restriction counseling. In addition, participants will receive seven scheduled follow-up contacts over a period of six months, along with usual psychiatric care. |
| Comparator Agent |
USUAL CARE |
Participants will receive standard psychiatric evaluation and management as per institutional protocol without structured safety planning or scheduled follow-up contacts. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
AGE 18 YEARS AND ABOVE, ATTEMPTED SUICIDE WHO ATTENDED EMERGENCY DEPARTMENT OF IPGME&R AND SSKM HOSPITAL, FLUENT IN LOCAL LANGUAGE AND WILLING TO CONSENT FOR THE STUDY |
|
| ExclusionCriteria |
| Details |
UNWILLING TO CONSENT FOR THE STUDY AND GCS SCORE LESS THAN 15 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN SUICIDAL IDEATION AND REPEAT SUICIDE ATTEMPTS |
6 MONTHS FOLLOW UP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GENERAL WELLBEING |
6 MONTHS FOLLOW UP |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Suicide attempt is a major public health concern and is associated with high risk of repetition and completed suicide. Evidence suggests that structured safety planning and follow-up contact interventions may reduce suicidal behaviour; however, data from tertiary care emergency settings in India are limited. This prospective, controlled interventional study aims to compare the effectiveness of Safety Planning Intervention (SPI) combined with periodic follow-up contacts in addition to usual care versus usual care alone among patients presenting with suicide attempt to the emergency department of a tertiary care hospital. Eligible participants will be allocated into two groups: the intervention group will receive structured safety planning and seven scheduled follow-up contacts over six months along with standard treatment, while the control group will receive usual care only. The primary outcome will be reduction in suicidal ideation and repeat suicide attempts over a six-month follow-up period. Secondary outcomes include changes in depression, anxiety, and overall well-being scores. The findings may help strengthen suicide prevention strategies in emergency care settings. |