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CTRI Number  CTRI/2019/06/019498 [Registered on: 03/06/2019] Trial Registered Prospectively
Last Modified On: 03/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Peer Support Programme for Prisoners with mental disorders 
Scientific Title of Study   Development and Feasibility Testing of Peer Support Programme for Prisoners with Common Mental Disorders(CMD) and substance Use(SU) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SreekanthT 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and NeuroSciences 
Address  Room number 227, Thunga Hostel, NIMHANS, Bangalore, Karnataka, India-560029

Bangalore
KARNATAKA
560029
India 
Phone  8123573648  
Fax    
Email  sreekanthnairgck@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aarti Jagannathan 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and NeuroSciences 
Address  No:106, First floor, Department of Psychiatric Social Work, M.V Govindswamy Centre, NIMHANS Bangalore KARNATAKA 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9448150690  
Fax    
Email  jaganaarti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aarti Jagannathan 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and NeuroSciences 
Address  No:106, First floor, Department of Psychiatric Social Work, M.V Govindswamy Centre, NIMHANS Bangalore KARNATAKA 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9448150690  
Fax    
Email  jaganaarti@gmail.com  
 
Source of Monetary or Material Support  
University Grant Commission Bahadur Shah Zafar Marg, New Delhi - 110002.  
 
Primary Sponsor  
Name  University Grand Commission Junior Research Fellowship 
Address  University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi - 110002 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sreekanth T  Central Prison, Bangalore  Central Prison Bangalore, Parappana Agrahara, Bangalore
Bangalore
KARNATAKA 
8123573648

sreekanthnairgck@gmail.com 
SreekanthT  National Institute of Mental Health and Neuro Sciences  Department of Psychiatric Social Work
Bangalore
KARNATAKA 
8123573648

sreekanthnairgck@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Mental Health and Neuro Sciences Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Convicted Prisoners and Jail Staff 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Not applicable 
Intervention  The Peer Support Programme   The peer support programme would be conducted by trained Prison volunteers and staff for a period of six months. This programme would be provided prisoners with common mental disorders and will help in identify, provide basic peer support and referral 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1.Male prisoners who have been convicted for a minimum of 6 months or longer
2.Age of the person between 18-60 years
3.The prisoners who have been identified as volunteers for various prison activities and willingness to provide peer support interviewed by the researcher as appropriate for the training.
4.Understand and speak fluently in Kannada or English language
5. Education of 8th standard and above and should have the ability to administer and document simple questionnaire.
6. Prison staff will include police constables, vocational trainers, medical staff

 
 
ExclusionCriteria 
Details  Nil 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of cases identified
 
At the end of 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Coping  Baseline and at the end of 6 months 
Wellbeing  Baseline and at the end of 6 months 
Knowledge about Mental illness  Baseline and at the end of 1 week 
Attitude towards mental illness  Baseline and at the end of 1 week 
Self esteem  Baseline and at the end of 1 week 
Subjective level of satisfaction   At the end of 6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/08/2019 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

There is a need to develop a model where peers and prison staff can be used as resources for identifying and providing supportive services to prisoners with common mental health and addiction. The process of development would include Systematic review of peer-support interventions in the prison to understand the models used across the world in the area of prisoner’s mental health. Further key informant interviews with mental health professionals (n= 3), prison officials (n = 3) and the forensic psychiatry team (n = 2) would be conducted to formulate a programme of conducting a peer support programme for prisoners with common mental health disorder and substance use in the Central Jail at Bengaluru, India. The peer support programme developed for feasibility testing would be in three phases. Phase1: Training peers (convicted prisoners) and staff of prison in mental health promotion, common mental health problems and substance use, identification of persons with common mental health problems, basic supportive skills and methods of referral. Phase 2: Conducting mental health promotion in different barracks in the prison by peers and staff. Phase 3: Identification and provision of mental health services to prisoners with 6 months follow up to assess, number of cases identified, number people referred, improvement in clients’ symptoms, coping and wellbeing, satisfaction and challenges of the trainers and the end users.

 
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