| CTRI Number |
CTRI/2024/03/064506 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Usefulness of regular contact in preventing repeat suicide attempts |
|
Scientific Title of Study
|
Efficacy of a co-designed brief contact and outreach intervention in attempted suicide: A Randomized Controlled Trial |
| 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 Vikas Menon |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Dept of Psychiatry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry-605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098158528 |
| Fax |
|
| Email |
drvmenon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Menon |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Dept of Psychiatry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry-605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098158528 |
| Fax |
|
| Email |
drvmenon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jilisha G |
| Designation |
PhD Scholar |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Dept of Psychiatry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry-605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488740321 |
| Fax |
|
| Email |
jillufenris@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund from Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry, 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Gorimedu, Dhanvantari Nagar, Puducherry, 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vikas Menon |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Room no-1080, Dept of Psychiatry, Old hospital block, JIPMER, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
8098158528
drvmenon@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Interventional studies), JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X838||Intentional self-harm by other specified means, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief contact and outreach intervention |
During baseline visit,
a) An IEC session (45-60 min) covering an overview of risk and protective factors for suicide, warning signs of a suicide crisis, coping strategies, and availing help during crisis.
b) These components will be included in a pamphlet which will be given to the participants.
c) The participants will also be oriented about safety planning intervention and a paper-based safety plan will be provided to them after the discussion.
After discharge from hospital,
a) Safety plan will be sent to them through SMS.
b) SMS messages with elements of safety planning, coping strategies etc. Helpline numbers will be included in the message content additionally.
The IEC session intervention will be provided once to all participants at baseline. The SMS intervention will be provided from the time of discharge till the study end point (2 years 6 months) to all participants. |
| Comparator Agent |
Treatment as usual |
A brief supportive counselling intervention as a 10-15 minute session with screening for psychiatric morbidity. Pharmacotherapy will be provided as needed and they will be referred to psychologist or social worker as appropriate. For those
with diagnosed psychiatric morbidity, additionally, the appropriate pharmacological intervention will be given along with follow-up advice and allocation to the appropriate follow-up clinic
(mood disorders/psychotic disorders clinic) where patients will come every four weeks for their drug refills. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with suicide attempts, confirmed using Columbia-Suicide Severity Rating Scale (C-SSRS), aged 18 years and above with access to mobile phones, admitted to the hospital and visiting Psychiatry department. |
|
| ExclusionCriteria |
| Details |
People with suicide attempts who are medically unstable, those who have known bipolar disorder or schizophrenia or are unable to give consent or those who refuse to participate. Patients with BPD and schizophrenia will also be excluded based on diagnosis by a qualified psychiatrist. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Increase in time to occurrence of first repeat suicide related event (occurrence of significant suicidal ideation, hospitalization for suicide related reasons, actual suicide attempt, interrupted attempt, or suicide) |
At baseline
At three months
At nine months
At eighteen months
At study endpoint
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Reduction in depressive symptoms
Improvement in coping
Improvement in general functioning |
At baseline
Three months after intervention
Nine months after intervention
Eighteen months after intervention
Study endpoint
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="362"
Sample Size from India="362"
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)
|
31/07/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
An initial brief Intervention during first contact and further sustained contact attempts at regular intervals could prove to be beneficial in reducing repeat suicide attempts. Hence, the current study aims to assess the efficacy of a brief contact and mHealth based intervention in reducing reattempts and suicidal ideation. The study will also assess the efficacy of the intervention in reducing depressive symptoms, functioning and in improving coping mechanisms of individual. |