FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [munoorinn@gmail.com].

  6. 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.

  7. 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.

 
Close