| CTRI Number |
CTRI/2022/02/040113 [Registered on: 08/02/2022] Trial Registered Prospectively |
| Last Modified On: |
21/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors Associated with Personal Recovery in Patients with Schizophrenia |
|
Scientific Title of Study
|
Personal Recovery and its Correlates in Patients with Schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarnajeet Das |
| Designation |
M.Phil Trainee |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Clinical Psychology
5th floor Academic Building
LGBRIMH
Tezpur
Sonitpur
ASSAM
784001
India
Department of Clinical Psychology
5th floor Academic Building
LGBRIMH
Tezpur
Sonitpur
ASSAM
784001
India
Sonitpur
ASSAM
784001
India |
| Phone |
9706793463 |
| Fax |
|
| Email |
sarnajeetdas95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Saxena |
| Designation |
Associate Professor & HOD |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Clinical Psychology
5th floor Academic Building
LGBRIMH
Tezpur
Sonitpur
ASSAM
784001
India
Department of Clinical Psychology
5th floor Academic Building
LGBRIMH
Tezpur
Sonitpur
ASSAM
784001
India
Sonitpur
ASSAM
784001
India |
| Phone |
9859931931 |
| Fax |
|
| Email |
priyasaxena175@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Saxena |
| Designation |
Associate Professor & HOD |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Clinical Psychology
5th floor Academic Building
LGBRIMH
Tezpur
Sonitpur
ASSAM
784001
India
Department of Clinical Psychology
5th floor Academic Building
LGBRIMH
Tezpur
Sonitpur
ASSAM
784001
India
Sonitpur
ASSAM
784001
India |
| Phone |
9859931931 |
| Fax |
|
| Email |
priyasaxena175@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Clinical Psychology, LGBRIMH, Tezpur |
|
|
Primary Sponsor
|
| Name |
Sarnajeet Das |
| Address |
Department of Clinical Psychology,LGBRIMH, Tezpur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sarnajeet Das |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
Department of Clinical
Psychology,Tezpur,
Sonitpur
ASSAM
Sonitpur
ASSAM |
9706793463
sarnajeetdas95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, LGBRIMH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female patients diagnosed with Schizophrenia Currently in remission. Individuals between 18 to 50 years of age.Individuals amenable for participation in the study. |
|
| ExclusionCriteria |
| Details |
Co morbid psychiatric disorders or neurological illness, as documented in patient’s file Presence of intellectual disability, as documented in patient’s file. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The research will help to understand the personal recovery perspectives. It will also help to understand what are the various factors associated with the experience of recovery, both internal as well as external factors. Personal recovery will be assessed as primary outcome measure at a single time point. |
One time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2022 |
| Date of Study Completion (India) |
21/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background of the study: Recovery among the patients with a psychiatric illness is an important aspect which impacts the overall experience of life. Studies show that apart from symptom reduction, the psychological recovery or personal recovery is an important aspect of the overall recovery. It is a way of living a satisfying, hopeful, and contributing life even with limitations caused by illness. The goal of treatment in severe mental illnesses has gradually evolved from a focus on symptom remission to a personal recovery–based approach. Aim & objectives: The aim of the present research is to study the experience of personal recovery and examine the factors associated with it in patients with schizophrenia. The specific objectives of the study are to examine the relationship between selected factors, such as, coping with stigma, patient satisfaction with mental health services, perceived social support, and personal recovery. And also qualitatively explore the subjective meaning and factors associated with personal recovery in patients with schizophrenia. Need of the study: There are very limited research related to recovery of patients with severe mental illness and associated factors in Indian context especially in north eastern part of India. This study has been undertaken to understand the factors associated with personal recovery in a tertiary hospital setting in Assam. Methodology: It will be a mixed-method study with a cross-sectional design, where, patients attending psychiatry OPD with schizophrenia will be included after applying inclusion and exclusion criteria and written consent. Tools to be applied: A Semi-structured socio-demographic data and PANSS will be used for initial screening and thereafter 76 patients will be assessed using Recovery Assessment Scale (RAS), Stigma Coping Orientation Scale (SCOS), Patient Satisfaction Questionnaire-18 (PSQ-18), Multidimensional Scale of Perceived Social Support and World Health Organization Quality of Life-Brief version scales. |