| CTRI Number |
CTRI/2019/01/017267 [Registered on: 25/01/2019] Trial Registered Prospectively |
| Last Modified On: |
14/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reforming psychiatric hospitals in India |
|
Scientific Title of Study
|
Psychiatric Hospital Reform in Low and Middle-income Countries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tasneem Raja |
| Designation |
Principal Investigator (Student) |
| Affiliation |
Tata Trusts |
| Address |
Tata Trusts, 26th Floor, World Trade Centre-Centre-1, Cuffe Parade, Mumbai-400005, Maharashtra
Mumbai
MAHARASHTRA
400005
India |
| Phone |
7506091860 |
| Fax |
|
| Email |
traja@tatatrusts.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Swaran Singh |
| Designation |
Supervisor |
| Affiliation |
University of Warwick |
| Address |
Head, Mental health and wellbeing
Warwick medical school
Coventry
United Kingdom
CV4 7AL
Other |
| Phone |
7920531216 |
| Fax |
|
| Email |
S.P.Singh@warwick.ac.uk |
|
Details of Contact Person
Public Query
|
| Name |
Tasneem Raja |
| Designation |
Principal Investigator |
| Affiliation |
Tata Trusts |
| Address |
Tata Trusts, 26th Floor, World Trade Centre-Centre-1, Cuffe Parade, Mumbai-400005, Maharashtra
Mumbai
MAHARASHTRA
400005
India |
| Phone |
7506091860 |
| Fax |
|
| Email |
traja@tatatrusts.org |
|
|
Source of Monetary or Material Support
|
| Tata Trusts, 26th Floor, Center 1, World Trade Center, Mumbai 400005
|
|
|
Primary Sponsor
|
| Name |
Tata Trusts |
| Address |
Tata Trusts, 26th Floor, World Trade Centre- Centre-1, Cuffe Parade, Mumbai |
| Type of Sponsor |
Other [Philanthropic Organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| RG Manudhane Motivation for Excellence Foundation |
2201, Anmol, A wing,off S.V. Road, Goregaon West, Mumbai 400067 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tasneem Raja |
Regional Mental Hospital Nagpur |
Regional Mental Hospital, Nelson Square, Chindwara Road, Nagpur
Nagpur
MAHARASHTRA |
7506091860
traja@tatatrusts.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vikas Anwesh Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F29||Unspecified psychosis not due to asubstance or known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Psychiatric Hospital Reform |
In patients who are not receiving SITAR |
| Intervention |
Structured Individualized Intervention and Recovery (SITAR) |
In Patients receiving SITAR along with the hospital reform components |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. A primary diagnosis of psychosis
2. Continuous length of stay in the hospital ≥ 12 to 120 months.
3. Male or female patient
4. Over the age of 18 years |
|
| ExclusionCriteria |
| Details |
1. Service users over the age of 60 years
2. Service users with neuro-developmental disorders such as epilepsy
3. Service users with Intellectual Disability
4. Service users in acute wards
5. Service users in forensic wards
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is disability levels as measured by the WHODAS 2 |
Baseline, post intervention- the intervention period being six months, three months post intervention and six months post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Social and Occupational Functioning |
Baseline, post intervention- the intervention period being six months, three months post intervention and six months post intervention |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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 1 |
|
Date of First Enrollment (India)
|
22/04/2019 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
DATA SHARING STATEMENT
Analyzed data will be shared with the co-authors of the study through a password-protected process. The password for the file will be shared through a phone call made for this purpose. No personal or primary data will be shared. The completely anonymized data set will be made available on request, with due permissions, in keeping with Indian legislation, once primary data analysis is published.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
None yet |