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
|
|
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
|
|
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. |