CTRI Number |
CTRI/2023/03/050896 [Registered on: 20/03/2023] Trial Registered Prospectively |
Last Modified On: |
04/03/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
Suicide Prevention Programme for Deaddiction Centre |
Scientific Title of Study
|
Development and Pilot Testing of a Suicide Prevention Programme for Persons with Substance Use Disorder |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Muhammed Noorudheen |
Designation |
Ph. D. Scholar |
Affiliation |
NIMHANS |
Address |
Room No 137
Department of Psychiatric Social Work
First floor Dr MV Govindaswamy Centre
National Institute of Mental Heath and Neuro Sciences
Hosur Road
Bengaluru 560029 Karnataka
Bangalore KARNATAKA 560029 India |
Phone |
9895877669 |
Fax |
|
Email |
munoorinn@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anish V Cherian |
Designation |
Associate Professor |
Affiliation |
NIMHANS |
Address |
Room No 139
Department of Psychiatric Social Work
First floor Dr MV Govindaswamy Centre
National Institute of Mental Heath and Neuro Sciences
Hosur Road
Bengaluru 560029 Karnataka
Bangalore KARNATAKA 560029 India |
Phone |
08026995917 |
Fax |
|
Email |
anishvcherian@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Muhammed Noorudheen |
Designation |
Ph. D. Scholar |
Affiliation |
NIMHANS |
Address |
Room No 137
Department of Psychiatric Social Work
First floor Dr MV Govindaswamy Centre
National Institute of Mental Heath and Neuro Sciences
Hosur Road
Bengaluru 560029 Karnataka
Bangalore KARNATAKA 560029 India |
Phone |
9895877669 |
Fax |
|
Email |
munoorinn@gmail.com |
|
Source of Monetary or Material Support
|
Dept. of Psychiatric Social Work and Centre for Addiction Medicine (CAM), National Institute of Mental Health and Neuro Sciences (NIMHANS). |
|
Primary Sponsor
|
Name |
University Grant Commission |
Address |
University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi - 110002. 011-23604446, 011-23604200. ugc@nic.in. |
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 |
Muhammed Noorudheen |
National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru |
Inpatient Wards (Male and Female), Centre for Addiction Medicine (CAM), Department of Psychiatry, NIMHANS, Hosur Road, Bengaluru 560029. Bangalore KARNATAKA |
9895877669
munoorinn@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Suicide Prevention Programme |
Total 4-6 group sessions will be done on alternative days, each group containing 4-7 participants. 80 to 90 min/session.
Importance and resources of help-seeking.
Association between Substance Use Disorder and suicide.
Knowledge includes Risk and protective factors of suicide.
Myths and Misconceptions about suicide.
Warning signs of suicide.
Steps in addressing suicidal thoughts.
Safety plan.
Treatment and follow up.
Total duration is approximately 14 days. |
Comparator Agent |
Treatment as Usual |
Treatment as Usual which provides from the centre for addiction medicine
Total duration is approximately 14 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
59.00 Year(s) |
Gender |
Both |
Details |
1. Participants who are taking in-patient treatment from the Centre for Addiction Medicine, NIMHANS.
2. Participants were diagnosed with substance use disorder.
2. Aged between 18-59 years.
4. Participants who can speak either Kannada, English, Malayalam or Tamil.
|
|
ExclusionCriteria |
Details |
1. Participants who have persisting psychotic symptoms, complex withdrawal, and cognitive impairments.
2. Participants who have chronic medical conditions. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Primary Outcome: Improve help seeking to reduce suicidal behaviours. |
at baseline, 4 weeks, and 8 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Enhancement in Knowledge of suicidal behaviours
Reduction of Stigma towards Suicide
|
at baseline, 4 weeks and, 8 weeks |
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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 3 |
Date of First Enrollment (India)
|
01/01/2024 |
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="3" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [munoorinn@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
|
Background of the study Suicide is a significant public health issue worldwide, particularly in India, where its multi-factorial etiology affects both the health and social sectors. Since, Substance use is one of the prominent risk factors for suicide, more efforts to address suicidality in the population needs to be initiated. Also, best of our knowledge, the current treatment is not addressing the preventive measures for suicide. It is crucial to develop interventions to address suicide prevention in this view. The current study aims to develop and pilot testing a suicide prevention program for persons with substance use disorder. Method The study will be adopted a mixed-method research design. The first two phases would adopt a qualitative research design to review the literature and need assessment to develop the suicide prevention program. The third phase would be using a Quasi-experimental mixed method research design, a waitlist comparison group with pretest-posttest, and a three month follow up to pilot testing of the developed programme. To recruit the participants in the quantitative and qualitative phases will adopt the consecutive sampling and the purposive sampling method, respectively. The persons taking treatment from the Centre for Addiction Medicine (CAM) NIMHANS are considered the study population. The study will be carried out in the IP service of CAM. Implication The study focuses on developing suicide prevention initiatives in addiction settings, considering that persons with substance use disorder are at high risk of suicide attempts and suicide. The current study addresses the gap between suicide prevention in addiction treatment. Primarily, the suicide prevention programme might be helping the participants in improving their help seeking for reducing suicidal behaviours. It also enhance knowledge and reduce the stigma toward suicide. Conclusion Contextually appropriate and culturally sensitive suicide prevention programmes can be protective factors preventing suicide attempts and suicide in post discharging scenarios. Inculcating the programme to the regular deaddiction treatment will be an effective strategy for suicide prevention. Additionally, the study outcome can be an integral part of the national suicide prevention strategy. |