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CTRI Number  CTRI/2022/04/042305 [Registered on: 29/04/2022] Trial Registered Prospectively
Last Modified On: 28/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Feasibility study for Social Cognition and Interaction Training (SCIT)]  
Study Design  Single Arm Study 
Public Title of Study   Adaptation and feasibility of Social Cognition and Interaction Training (SCIT) for persons with Schizophrenia 
Scientific Title of Study   Feasibility of social cognition and interaction training in persons with schizophrenia adapted to an Indian context 
Trial Acronym  FOSCITS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Upasana Ravinder 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS)  
Address  Psychiatric Rehabilitation Services, National Institute of Mental Health and Neurosciences, Hosur Road / Marigowda Road, Bangalore – 560029 Karnataka, India.

Bangalore
KARNATAKA
560029
India 
Phone  9810792049  
Fax    
Email  upasanaravinder@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Poornima Bhola 
Designation  Professor, Department of Clinical Psychology 
Affiliation  National Institute of Mental Health and Neurosciences, Bangalore, India 
Address  Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur Road/ Marigowda Road, Bangalore – 560029 Karnataka, India.

Bangalore
KARNATAKA
560029
India 
Phone  9844026260  
Fax    
Email  poornimabhola@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Poornima Bhola 
Designation  Professor, Department of Clinical Psychology 
Affiliation  National Institute of Mental Health and Neurosciences, Bangalore, India 
Address  Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur Road/ Marigowda Road, Bangalore – 560029 Karnataka, India.

Bangalore
KARNATAKA
560029
India 
Phone  9844026260  
Fax    
Email  poornimabhola@gmail.com  
 
Source of Monetary or Material Support  
NIMHANS PhD Institutional Stipend and annual contingency grant for students 
 
Primary Sponsor  
Name  NIMHANS  
Address  National Institute of Mental Health and Neuro Sciences (NIMHANS) Hosur Road / Marigowda Road, (Lakkasandra, Wilson Garden) Bangalore – 560029 Karnataka, India. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Upasana Ravinder  National Institute of Mental Health and Neurosciences  Department: Psychiatry Division: Psychiatric Rehabilitation Services Room: Consultation room, second floor, DPNR building, National Institute of Mental Health and Neurosciences, Hosur Road / Marigowda Road, Bangalore – 560029 Karnataka, India.
Bangalore
KARNATAKA 
9810792049

upasanaravinder@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (BEHAVIOURAL SCIENCES DIVISION), NIMHANS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA This is a single arm open label trial, hence, there is no comparator agent. 
Intervention  Social Cognition and Interaction Training (SCIT)   A manualized treatment with three modules; (introduction and emotions, figuring out situations and checking it out) that targets social cognitive deficits and biases among adults with schizophrenia (Roberts & Penn, 2016). This module will be adapted for use in an Indian Context. The module will be delivered over a time frame of approximately 2-2.5 months for a duration for 45-60 minutes per session based on adaptation and feasibility.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Persons diagnosed with Schizophrenia
2) Duration of illness <10 years
3) CGI score<3
4) Change of medications by less than 25% of their dose in the past 8 weeks
5) Minimum education up to class 7.
6) 18-50 years of age
7) Working knowledge of English or Hindi
 
 
ExclusionCriteria 
Details  1) Co-morbid neurological conditions
2) History of head injury
3) Current substance dependence, except nicotine
4) Clinical evidence of intellectual disability
5) Current symptoms of severe depression
6) Having undergone electroconvulsive therapy in the preceding six months
7) Having received social skills/cognition training of at least ten sessions in the past one year.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is Social Cognition  Baseline and post-intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
Symptomatology, neuro-cognition, recovery, quality of life and disability.
Other aspects of feasibility i.e. acceptability, attrition rate and rate of recruitment. 
Baseline and post-intervention.
Aspects of acceptability of the intervention such as satisfaction with the intervention will be evaluated post each module 
 
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" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/05/2022 
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="4"
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 - NO
Brief Summary  

Aim and Objectives: The primary aim of this study is to adapt Social Cognition and Interaction Training (SCIT) to an Indian Context and evaluate its feasibility in patients with Schizophrenia.  Following are the  objectives as per the phase in which the study will take place:

 

Phase I:

To adapt SCIT to an Indian context.

Phase II:

To evaluate the feasibility of a contextually adapted intervention for social cognition in patients with schizophrenia.


(1)   To examine the rate of recruitment to the study among eligible patients with schizophrenia.

(2)   To examine the attrition rate among eligible patients consenting to receive the intervention.

(3)   To examine the acceptability of the intervention among eligible patients receiving the intervention.


        (4)   To conduct limited efficacy testing of the adapted intervention on outcome measures of social cognition, symptoms of schizophrenia, neurocognition,   recovery, quality of life, and disability.

 

Background and Rationale: Social cognition refers to mental operations that underlie social interactions, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others. Social cognition is considered to have four primary domains: emotional and social perception, theory of mind (ToM), and attributional style. Social Cognition has been identified as a deficit consistently across various stages and episodes in persons with Schizophrenia. In the Indian context, though social cognition as a domain has been researched along with the adaptation of tools to measure social cognition, published research on comprehensive interventions for social cognition as well as their availability and implementation is limited. Hence, it was decided to adapt called “Social Cognition and Interaction Training (SCIT)” in an Indian context, which has efficacy in various settings and has been adapted in various countries. This intervention widely covers the domains of social cognition and approaches intervention purely from a social cognitive perspective while taking a practical standpoint. It is thus important to have a contextualized intervention that is also feasible to use.

Method: This study will follow an open-label design with a single-arm experimental research design with baseline, post-module (aspects of acceptability), and post-intervention assessments. This study will be conducted in two main phases wherein the first phase would involve adaptation (in terms of the process, duration, frequency, mode of delivery, content, language, images, video, audio files, etc.) of the intervention in consultation with the authors (with expert validation), and a pilot study for patients with schizophrenia early in their course.

The second phase of the study aims to evaluate the feasibility of the intervention in domains of acceptability, recruitment rate, attrition, and limited-efficacy testing (n=30) for patients with schizophrenia early in their course, with > 10 years duration of illness, between 18-50 years of age with minimum education till class 7. Some of the outcome measures associated with limited-efficacy testing include symptomatology, social cognition, neuro-cognition, recovery, quality of life, and disability. Towards the end, attempts will be made to manualize the adapted intervention and make it widely accessible for use.

Analysis: Appropriate statistical analysis techniques involving descriptive and inferential statistics will be used, along with thematic analysis for the qualitative aspects for interpretation.

 
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