| CTRI Number |
CTRI/2021/12/039039 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Individualised Rehabilitation Intervention] |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Understand rehabilitation needs of women with severe mental illness and to provide individualised rehabilitation intervention |
|
Scientific Title of Study
|
Individualized Rehabilitation Intervention for Women with Severe mental illness in rural Karnataka- development and feasibility testing |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meera J |
| Designation |
Phd Student |
| Affiliation |
National institute of mental health and neuro sciences (NIMHANS) |
| Address |
15,PRS building 3rd floor National Institute of Mental Health and Neurosciences, hosur road
bangalore 560029
National Institute of Mental Health and Neurosciences, hosur road
bangalore 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
6362887924 |
| Fax |
|
| Email |
meerapsw@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Sivakumar |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Additional Professor,Dept of Psychiatry Room no 4,Psychiatric Rehabilitation Services 3rd floor National Institute of Mental Health and Neurosciences hosur road Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9379488666 |
| Fax |
|
| Email |
drt.sivakumar@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shanivaram Reddy |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Room no 10
Department of Psychiatric Social Work
National Institute of Mental Health and Neurosciences
Bangalore-560029, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9480747319 |
| Fax |
|
| Email |
shanivaramreddyk@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences (NIMHANS) |
|
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Primary Sponsor
|
| Name |
National institute of Mental Health and Neurosciences |
| Address |
National Institute of Mental Health and Neurosciences(NIMHANS)
Hosur road, Bangalore 560029 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| meera |
National Institute of Mental Health and Neurosciences |
15,prs third floor, Hosur road,Bangalore-560029
Davanagere
KARNATAKA |
6362887924
meerapsw@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Behavioural science division ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, (2) ICD-10 Condition: F310||Bipolar disorder, current episodehypomanic, (3) ICD-10 Condition: F203||Undifferentiated schizophrenia, (4) ICD-10 Condition: F319||Bipolar disorder, unspecified, (5) ICD-10 Condition: F22||Delusional disorders, (6) ICD-10 Condition: F21||Schizotypal disorder, (7) ICD-10 Condition: F250||Schizoaffective disorder, bipolartype, (8) ICD-10 Condition: F251||Schizoaffective disorder, depressive type, (9) ICD-10 Condition: F258||Other schizoaffective disorders, (10) ICD-10 Condition: F201||Disorganized schizophrenia, (11) ICD-10 Condition: F202||Catatonic schizophrenia, (12) ICD-10 Condition: F205||Residual schizophrenia, (13) ICD-10 Condition: F208||Other schizophrenia, (14) ICD-10 Condition: F301||Manic episode without psychotic symptoms, (15) ICD-10 Condition: F302||Manic episode, severe with psychotic symptoms, (16) ICD-10 Condition: F303||Manic episode in partial remission, (17) ICD-10 Condition: F308||Other manic episodes, (18) ICD-10 Condition: F311||Bipolar disorder, current episodemanic without psychotic features, (19) ICD-10 Condition: F312||Bipolar disorder, current episodemanic severe with psychotic features, (20) ICD-10 Condition: F313||Bipolar disorder, current episodedepressed, mild or moderate severity, (21) ICD-10 Condition: F314||Bipolar disorder, current episodedepressed, severe, without psychotic features, (22) ICD-10 Condition: F315||Bipolar disorder, current episodedepressed, severe, with psychotic features, (23) ICD-10 Condition: F317||Bipolar disorder, currently in remission, (24) ICD-10 Condition: F318||Other bipolar disorders, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Rehabilitation Intervention for Women with Severe Mental Illness in Rural Karnataka- Development and Feasibility Testing |
tailor-made interventions will be provided for women with severe mental illness |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Disorders with primary diagnosis meeting the criteria as per International Classification of Diseases (ICD-10) for F.20.0-29; Schizophrenia Schizotypal and delusional disorder, F.31.0-31.9; Bipolar Affective Disorder. |
|
| ExclusionCriteria |
| Details |
Individuals who are not amenable to qualitative interviews.
Individuals with any neurological disability or life-threatening illness requiring priority medical management.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome: Reduction in disability score
Indian Disability Evaluation and Assessment Scale (IDEAS) will be used to assess the reduction in the disability score. Scale used are Indian Disability Evaluation and Assessment Scale (IDEAS) Rehabilitation committee of the Indian Psychiatric Society 2002) |
T1 baseline before the intervention
T2 six months after the intervention |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Variables are symptom severity,Level of functioning factors influencing adherence, stigma,Quality of life. Scale used are Clinical impression scale CGI-SCH, CGI- BP (Haro et al., 2003), (Spearing et al., 1997)World Health Organisation Disability Assessment Schedule (WHO-DAS 2.012) item interviewer rating WHO 2010Schedule of Factors Influencing Adherence (SOFIA) Reddy 2013 Internalized stigma of Mental Illness Scale (ISMI) Ritsher, J. B, 2003World Health Organisation-Quality of life -Bref(WHOQOL-bref) WHO 2001 |
T1 baseline before the intervention
T2 six months after the intervention |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/01/2022 |
| 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 Yet Recruiting |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [meerapsw@gmail.com].
- For how long will this data be available start date provided 16-11-2022 and end date provided 16-11-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Women with mental health problems are vulnerable due to gender-specific factors and have limitations in accessing appropriate care. Prior research into rehabilitation need assessment has addressed issues unique to women with mental illness. Available studies were conducted in institutional settings with a cross-sectional design. There is paucity of literature on addressing issues unique to women with severe mental illness in rural communities. Thus, there is a need to study and address rehabilitation needs of women with mental illness in rural community. This will help develop rehabilitation interventions to address unique needs of women with severe mental illness in rural communities. For this researcher would initially develop need assessment interview guide to assess the rehabilitation needs unique to women with severe mental illness in Jagaluru. Need assessment would be followed by development of individualised rehabilitation intervention after in person interview with stakeholders. Individualised intervention would be provided to 30 women recruited through convenience sampling method. Research would be using mixed methodology as research design and would do analysis using thematic analysis (qualitative data) and appropriate statistical tests for quantitative data. |