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
|
|
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 |
|
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.
|