| CTRI Number |
CTRI/2016/01/006571 [Registered on: 27/01/2016] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Psychiatric Social Work Intervention to Enhance Insight on illness in Persons with Schizophrenia" |
|
Scientific Title of Study
|
"Efficacy of Psychiatric Social Work Intervention as an Add on measure in enhancing insight among persons with first episode schizophrenia" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Boban Joseph |
| Designation |
Ph.D Scholar |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatric Social Work,M.V Govindaswamy Block,PB No 2900,NIMHANS,Dharmaram PO,Bangalore,Karnataka,India
Department of Psychiatric Social Work,M.V Govindaswamy Block,PB No 2900,NIMHANS,Dharmaram PO,Bangalore,Karnataka,India
Bangalore
KARNATAKA
56029
India |
| Phone |
09483429290 |
| Fax |
|
| Email |
bobinjoseph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivarama Varambally |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Additional Professor
Dept. of Psychiatry
PB No 2900
NIMHANS
Bengaluru
Consultant
Schizophrenia Clinic
PB No 2900
NIMHANS
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
ssv.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivarama Varambally |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Additional Professor
Dept. of Psychiatry
PB No 2900
NIMHANS
Bengaluru
Consultant
Schizophrenia Clinic
PB No 2900
NIMHANS
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
ssv.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health And Neuro SciencesInstitute of National Importance |
| Address |
Department of Psychiatric Social Work, PB No 2900
NIMHANS, Bengaluru 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Boban Joseph |
Out Patient Under Department of Psychiatry and Schizophrenia Clinic |
National Institute of Mental Health and Neurosciences,Department of Psychiatry,PB No 2900,Bengaluru-560029
Bangalore
KARNATAKA |
09483429290
bobinjoseph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
First episode schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention Group |
In intervention Group the researcher will be provided treatment for the randomly included participants based on the package developed for insight as part of the study. |
| Comparator Agent |
Treatment As Usual |
In this group The Researcher make sure that the randomly included participants receives routine clinical care for the participants. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Diagnosis of DSM V criteria for Schizophrenia
2)Subjects symptoms should be stabilized on regular medication minimum 3 months prior to the entry into the study.
3)Subjects insight score should be 4 or less in the CGI severity Scale
4)Duration of illness is greater or equal to 6 months to less or equal to 5 years
5)Family caregiver who accompany the person with first episode schizophrenia to NIMHANS OPD |
|
| ExclusionCriteria |
| Details |
1)Subjects with history of any comorbid psychiatric or neurological disorders.
2)Subjects with psychiatric emergencies(i.e catatonia,suicidal ideation,aggression)
3)Subjects with substance abuse/dependence
4)Subjects with severe formal thought disorder
5)Subjects with intellectual disability as assessed clinically. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Better self knowledge and Insight
2)Decreased internalized stigma
2)Better treatment attitude
3)Better socio-occupational functioning
4)Higher chances of early remission.
|
Baseline and Immediately after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Decreased involuntary hospitalization
2)Able to identify warning signs and side effects
3)Fewer incidence of destructive behaviour.
4)Better coping
5)Low Expressed Emotions
6)Reduced deficits due to illness
7)Early Remission
8)Decreased Duration of Untreated Psychosis |
Baseline and immediately after the post intervention. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/08/2015 |
| Date of Study Completion (India) |
29/04/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Insight is a critical factor in determining recovery from schizophrenia.Lack of insight into the illness is a cardinal symptom which is seen by researchers and clinical diagnostic manuals as a hindrance to seeking and continuing required treatment by the affected population.The relevance of this study is that, There are lack of studies attempted in improving insight into schizophrenia in India under psychosocial basis.If research can develop an effective package based on psychosocial grounds at the first episode itself then we could restrict or reduce the duration of illness by providing effective treatment and the rest of the negative consequences among people with schizophrenia and their care providers .Hence, this study is an attempt to develop and test the efficacy of an exclusive Psychiatric Social Work Intervention for insight enhancement for person with first episode schizophrenia in the clinical setting.This study is Randomised Controlled Trial with Researcher blinding,random allocation of subjects to the study etc.If the study proved effective in results then, it would be widely used in the mental health clinical setting by any multi-disciplinary team member for a wide population during their first episode of schizophrenia across any centres in our country. |